Endometrial Cancer Clinical Trial Pipeline Insights: 50+ Companies Shaping Future Treatment Paradigms
New York, USA, July 15, 2025 (GLOBE NEWSWIRE) -- Endometrial Cancer Clinical Trial Pipeline Insights: 50+ Companies Shaping Future Treatment Paradigms | DelveInsight
Endometrial Cancer is a type of cancer that begins in the lining of the uterus, most commonly affecting postmenopausal women. Rising prevalence due to increasing obesity rates and aging population, along with advancements in targeted therapies and early diagnostic tools, are key factors driving market growth.
DelveInsight's 'Endometrial Cancer Pipeline Insight 2025' report provides comprehensive global coverage of pipeline endometrial cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the endometrial cancer pipeline domain.
Key Takeaways from the Endometrial Cancer Pipeline Report
DelveInsight's endometrial cancer pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline endometrial cancer drugs.
Key endometrial cancer companies such as Eli Lilly and Company, Karyopharm Therapeutics, NETRIS Pharma, TORL Biotherapeutics, Compugen, 3D Medicines, Evergreen Therapeutics, Acrivon Therapeutics, Eisai, Xadcera Biopharmaceutical (Suzhou) Co., Ltd., Huabo Biopharm Co., Ltd., Multitude Therapeutics, Context Therapeutics, Leap Therapeutics, Mersana Therapeutics, MacroGenics, Accent Therapeutics, Shanghai Henlius Biotech, Imvax, and others are evaluating new endometrial cancer drugs to improve the treatment landscape.
Promising pipeline endometrial cancer therapies, such as Selinexor, Abemaciclib, NP137, TORL-1-23, COM 701, Envafolimab, EG-007, Prexasertib, E7386, DM002, HB0025, AMT-151, CTIM-76, Sirexatamab (DKN-01), XMT-1660, MGC026, DHX9 (ATX-559), HLX17, IEC-001, and others, are in different phases of endometrial cancer clinical trials.
In June 2025, Daiichi Sankyo announced the first patient had been dosed in the DESTINY-Endometrial01 clinical trial evaluating Enhertu (trastuzumab deruxtecan) in combination with rilvegostomig or Merck's Keytruda (pembrolizumab) as a first-line treatment for patients with HER2-expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
In May 2025, Kaida BioPharma announced it had entered into a manufacturing agreement with Northway Biotech, Inc., an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), for the manufacturing of lead product candidate, KAD101.KAD101, a novel biologic prolactin receptor antagonist, is being initially developed for the treatment of platinum-resistant ovarian cancer (PROC) with expansion opportunities into endometrial, uterine, and breast cancers.
In May 2025, PRISM BioLab, Co. Ltd. announced that the analysis of a combination study of E7386 created through collaboration research with Eisai Co., Ltd., and Lenvatinib mesylate will be presented by Eisai at the American Society of Clinical Oncology (ASCO) Congress 2025, held in Chicago, USA from May 30 to June 3, 2025. To determine the optimal dose of E7386 in combination with Lenvatinib in the open-label Phase Ib study (NCT04008797), expansion cohort of advanced endometrial cancer patients who progressed following platinum-based chemotherapy and anti-PD (L)1 immunotherapy have been implemented by Eisai, and the enrollment of 30 patients was completed.
In March 2025, Faeth Therapeutics and The GOG Foundation, Inc. (GOG-F) announced that the first patient has been dosed in its Phase II combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel. The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer.
In February 2025, Acrivon Therapeutics announced that the FDA had granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer.
In December 2024, Repare Therapeutics Inc. reported positive data from its MYTHIC Phase I gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase II dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.
In December 2024, IDEAYA Biosciences, Inc. announced that it has dosed the first patient in the IDEAYA-sponsored Phase I trial evaluating the combination of IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in endometrial cancer patients with high microsatellite instability (MSI-high) and microsatellite stable(MSS).
Request a sample and discover the recent advances in endometrial cancer drugs @ Endometrial Cancer Pipeline Report
The endometrial cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage endometrial cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the endometrial cancer clinical trial landscape.
Endometrial Cancer Overview
Endometrial cancer, which arises from the uterus's inner lining (the endometrium), is the most common gynecologic cancer in developed countries, with its occurrence steadily increasing. This rise is linked to factors like aging populations and growing obesity rates. Most diagnoses occur in postmenopausal women, with abnormal uterine bleeding being the most frequent symptom. Because this symptom often prompts early medical evaluation, many cases are detected at an initial stage, improving treatment success.
Several risk factors play a role in the development of endometrial cancer. Obesity, metabolic syndrome, and diabetes are key contributors, with obesity responsible for about 40% of cases. Reproductive history, such as early onset of menstruation, delayed menopause, never having given birth, and infertility, also raises risk. Genetic factors, especially Lynch syndrome, increase susceptibility. In contrast, combined oral contraceptives have been linked to a decreased risk.
Diagnosis usually involves an endometrial biopsy, often following a transvaginal ultrasound to measure endometrial thickness. However, research suggests transvaginal ultrasound can produce false-negative results, particularly in Black women, indicating that biopsy remains the definitive diagnostic method. Surgical staging, based on the International Federation of Gynecology and Obstetrics (FIGO) criteria, is essential for assessing disease extent and planning treatment.
Treatment varies by stage. Early-stage disease is generally treated with a total hysterectomy and removal of both ovaries and fallopian tubes. Additional therapies such as radiation or chemotherapy may be recommended depending on risk factors. For advanced or recurrent disease, newer treatments like immunotherapy show promise. In particular, the combination of dostarlimab (JEMPERLI) with chemotherapy has improved survival in advanced or recurrent cases. Research continues to evolve to optimize these treatment approaches and improve patient outcomes.Find out more about endometrial cancer drugs @ Endometrial Cancer Treatment
A snapshot of the Pipeline Endometrial Cancer Drugs mentioned in the report:
Drugs
Company
Phase
MoA
RoA
Selinexor
Karyopharm Therapeutics
III
Exportin 1 protein inhibitors
Oral
EG-007
Evergreen Therapeutics
III
Epidermal growth factor receptor antagonists
Injectable
Abemaciclib
Eli Lilly and Company
II
Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors
Oral
Envafolimab
Alphamab Oncology/Ascletis/3D Medicine
II
Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
Subcutaneous
Sirexatamab (DKN-01)
Leap Therapeutics
II
DKK1 protein inhibitors
Intravenous
NP137
NETRIS Pharma
II
Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
Intravenous
COM 701
Compugen
I/II
Antibody-dependent cell cytotoxicity; CD112 receptor antagonists; T lymphocyte stimulants
Intravenous
XMT-1660
Mersana Therapeutics
I
Tubulin inhibitors
Intravenous
Learn more about the emerging endometrial cancer therapies @ Endometrial Cancer Clinical Trials
Endometrial Cancer Therapeutics Assessment
The endometrial cancer pipeline report proffers an integral view of the emerging endometrial cancer therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action.
Scope of the Endometrial Cancer Pipeline Report
Coverage: Global
Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
Therapeutics Assessment By Mechanism of Action: Exportin 1 protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, T lymphocyte stimulants, Programmed cell death-1 ligand-1 inhibitors, Endopeptidase Clp stimulants, TNF-related apoptosis-inducing ligand receptor agonists, DKK1 protein inhibitors, Tubulin inhibitors, Epidermal growth factor receptor antagonists
Key Endometrial Cancer Companies: Eli Lilly and Company, Karyopharm Therapeutics, NETRIS Pharma, TORL Biotherapeutics, Compugen, 3D Medicines, Evergreen Therapeutics, Acrivon Therapeutics, Eisai, Xadcera Biopharmaceutical (Suzhou) Co., Ltd., Huabo Biopharm Co., Ltd., Multitude Therapeutics, Context Therapeutics, Leap Therapeutics, Mersana Therapeutics, MacroGenics, Accent Therapeutics, Shanghai Henlius Biotech, Imva,x and others.
Key Endometrial Cancer Pipeline Therapies: Selinexor, Abemaciclib, NP137, TORL-1-23, COM 701, Envafolimab, EG-007, Prexasertib, E7386, DM002, HB0025, AMT-151, CTIM-76, Sirexatamab (DKN-01), XMT-1660, MGC026, DHX9 (ATX-559), HLX17, IEC-001, and others.
Dive deep into rich insights for new endometrial cancer treatments, visit @ Endometrial Cancer Drugs
Table of Contents
1.
Endometrial Cancer Pipeline Report Introduction
2.
Endometrial Cancer Pipeline Report Executive Summary
3.
Endometrial Cancer Pipeline: Overview
4.
Analytical Perspective In-depth Commercial Assessment
5.
Endometrial Cancer Clinical Trial Therapeutics
6.
Endometrial Cancer Pipeline: Late-Stage Products (Pre-registration)
7.
Endometrial Cancer Pipeline: Late-Stage Products (Phase III)
8.
Endometrial Cancer Pipeline: Mid-Stage Products (Phase II)
9.
Endometrial Cancer Pipeline: Early-Stage Products (Phase I)
10.
Endometrial Cancer Pipeline Therapeutics Assessment
11.
Inactive Products in the Endometrial Cancer Pipeline
12.
Company-University Collaborations (Licensing/Partnering) Analysis
13.
Key Companies
14.
Key Products in the Endometrial Cancer Pipeline
15.
Unmet Needs
16.
Market Drivers and Barriers
17.
Future Perspectives and Conclusion
18.
Analyst Views
19.
Appendix
For further information on the endometrial cancer pipeline therapeutics, reach out @ Endometrial Cancer Therapeutics
Related Reports
Endometrial Cancer Epidemiology Forecast
Endometrial Cancer Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted endometrial cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Endometrial Cancer Market
Endometrial Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometrial cancer companies, including GlaxoSmithKline, Merck & Co, AstraZeneca, Karyopharm Therapeutics, Evergreen Therapeutics, Incyte Corporation, among others.
Advanced Endometrial Cancer Pipeline
Advanced Endometrial Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced endometrial cancer companies, including Incyte Corporation, Byondis B.V., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Ability Pharmaceuticals SL, Zymeworks Inc., AstraZeneca, Eli Lilly and Company, Pfizer, Karyopharm Therapeutics, Genentech, Eli Lilly and Company, Genentech, Inc., NETRIS Pharma, Five Prime Therapeutics, Inc., Millennium Pharmaceuticals, Inc., Novartis Oncology, Takeda, Mundipharma-EDO GmbH, Zai Lab (Shanghai) Co., Ltd., Haihe Biopharma Co., Ltd., Xencor, Compugen Ltd, Checkpoint Therapeutics, Inc., Celon Pharma SA, Dragonfly Therapeutics, among others.
Endometriosis Pipeline
Endometriosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis companies, including Enteris BioPharma, Bayer, Hope Medicine, Tiumbio, Organon, among others.
Endometriosis Pain Market
Endometriosis Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others.
Endometriosis Pain Pipeline
Endometriosis Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others.
DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion.
Other Business Pharmaceutical Consulting Services
Healthcare Conference Coverage
Pipeline Assessment
Healthcare Licensing Services
Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences.
Connect with us at LinkedIn
CONTACT: Contact Us Shruti Thakur info@delveinsight.com +14699457679 www.delveinsight.comSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
3 hours ago
- Business Upturn
Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
New York, USA, July 22, 2025 (GLOBE NEWSWIRE) — Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment options. Melanoma Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. Uveal Melanoma Market Uveal Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key uveal melanoma companies, including Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co, GlaxoSmithKline, Janssen, among others. Metastatic Melanoma Market Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic melanoma companies, including Cancer Insight LLC, Elios Therapeutics LLC, Evaxion Biotech A/S, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, InxMed (Shanghai) Co. Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on LinkedIn|Facebook|Twitter Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
8 hours ago
- Yahoo
Medical Packaging Films Market Size to Expand 1.9X from 2025 Driving USD 17.65 Bn by 2034
According to a recent analysis by Towards Packaging, the global medical packaging films market is projected to expand from USD 8.72 billion in 2024 to USD 17.65 billion by 2034, recording a CAGR of 7.3% between 2025 and 2034. Ottawa, July 22, 2025 (GLOBE NEWSWIRE) -- The global medical packaging films market size was recorded at USD 9.36 billion in 2025 and is forecast to increase to USD 17.65 billion in 2034, as per findings from a study published by Towards Packaging, a sister firm of Precedence medical packaging films market is driven by increasing demand for safe, durable, and contamination-resistant packaging solutions in the healthcare sector. These films are widely used for packaging pharmaceuticals, medical devices, and diagnostic products, ensuring product integrity, extended shelf life, and protection against external factors such as moisture, oxygen, and microbial contamination. Advancements in material science and the growing preference for flexible packaging formats over rigid alternatives are accelerating innovation in film structures and barrier properties. Additionally, rising healthcare expenditure, aging populations, and stringent regulatory requirements regarding medical product safety and sterility contribute to the market's steady growth. Sustainability concerns are also influencing the shift toward recyclable and bio-based medical packaging films. What is Meant by Medical Packaging Films? Medical packaging films refer to specialized plastic films used to package medical and healthcare products, ensuring their safety, sterility, and integrity throughout storage, transportation, and usage. These films are designed to meet stringent regulatory and hygiene standards, offering excellent barrier properties against moisture, oxygen, light, and contaminants. They are commonly used for packaging items such as surgical instruments, medical devices, pharmaceuticals, diagnostic kits, and disposable products. Medical packaging films can be made from various materials, including polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), and polyethylene terephthalate (PET), depending on the required strength, flexibility, and protective qualities. Often used in multi-layered structures, these films may also incorporate features like peelability, seal strength, and transparency for easy inspection and handling. Their role is critical in maintaining product sterility, preventing cross-contamination, and ensuring patient safety, particularly in highly sensitive and regulated environments such as hospitals, laboratories, and pharmaceutical manufacturing Are the Latest Trends in the Medical Packaging Films Market? Smart Packaging Technologies Medical packaging films are increasingly integrated with smart features like sensors, QR codes, and RFID tags, enabling real-time tracking of temperature, humidity, and tampering for sensitive healthcare products. Active and Antimicrobial Films The use of active packaging films embedded with oxygen scavengers, moisture absorbers, and antimicrobial agents is rising to maintain sterility and extend the shelf life of pharmaceuticals and medical devices. High-Barrier Multi-Layer Films Advanced multilayer film structures are being adopted widely to offer superior resistance to external contaminants such as moisture, oxygen, and light, ensuring the integrity of medical products during storage and transport. Sustainable and Eco-Friendly Materials There is a growing trend toward using sustainable packaging materials like recyclable, bio-based, and compostable films that reduce environmental impact without compromising safety or performance standards. Patient-Centric and Safety-Enhanced Designs Manufacturers are focusing on developing films with child-resistant, senior-friendly, and tamper-evident features to ensure product safety, ease of use, and better patient adherence to prescribed is the Potential Growth Rate of the Medical Packaging Films Market? Growing Healthcare Expenditure Globally Increased healthcare investments by governments and private players are supporting the infrastructure and demand for medical packaging solutions. For instance, in January 2025, the Organisation for Economic Co-operation and Development, India's healthcare budget is expected to double from Rs 3.2 lakh crore in 2020 - 2021 to Rs 6.1 lakh crore in 2025. This amounts to an 18% compound annual growth rate. The Department of Health and Family Welfare will get a sizable amount of this spending, which is an 11% increase over the prior year. Limitations & Challenges in the Medical Packaging Films Market: Strict Regulatory and Compliance Requirements & Environmental Concerns Related to Plastic Waste The key players operating in the medical packaging films market are facing issues due to strict regulatory laws and environmental concerns. Volatility in the prices of petroleum-based raw materials like polyethylene and polypropylene affects production costs and profit margins. Meeting the complex and varying global regulations for medical packaging involves time-consuming certification processes and high costs. The non-biodegradable nature of many medical films raises sustainability concerns, leading to regulatory pressure and consumer pushback. Medical packaging waste, especially contaminated films, is difficult to recycle due to strict safety protocols and a lack of proper facilities. More Insights of Towards Packaging: Radioactive Material Packaging Market - The global radioactive material market is forecast to grow at a CAGR of 5.14%, from USD 847.33 million in 2025 to USD 1326.84 million by 2034. Sterile Medical Containers Market - The sterile medical containers market is booming, poised for a revenue surge into the hundreds of millions from 2025 to 2034. Medical Tubing and Catheters Market - The global medical tubing and catheters market is forecast to grow from USD 36.00 billion in 2025 to USD 74.99 billion by 2034, driven by a CAGR of 8.5% from 2025 to 2034. Medical Transport Box Market - The medical transport box market is expected to increase from USD 801.15 million in 2025 to USD 1488.77 million by 2034, growing at a CAGR of 7.14%. Sterile Medical Paper Packaging Market - Consumer Insights & Growth Strategies Healthcare facilities worldwide are focusing more on infection control, leading to a surging demand for sterile medical paper packaging. Medical Device Packaging Market - The global medical device packaging market size was valued at USD 29.70 billion in 2024 and anticipated to calculate USD 60.76 billion by 2034, expanding at a 7.42%. Meat Packaging Films Market - The meat packaging films market is expected to increase from USD 5.63 billion in 2025 to USD 8.81 billion by 2034, growing at a CAGR of 5.1% throughout the forecast period from 2025 to 2034. Micro Perforated Films Packaging Market - The micro perforated films market is projected to reach USD 3.09 billion by 2034, growing from USD 2.02 billion in 2025. Peelable Lidding Films Market - The global peelable lidding films market is set to rise from USD 687.05 million in 2024 to USD 1,196.02 million by 2034, registering a CAGR of 5.7% from 2025 to 2034. Biodegradable Plastic Films Market - The biodegradable plastic films market is predicted to expand from USD 1.31 billion in 2025 to USD 1.95 billion by 2034, growing at a CAGR of 4.50%. Regional Analysis: Who is the Leader in the Medical Packaging Films Market? Asia Pacific dominates the medical packaging films market due to its rapidly expanding pharmaceutical and healthcare industries, driven by large population bases and increasing healthcare expenditures in countries such as China, India, and Japan. The increasing demand for affordable and high-quality medical treatments, combined with government initiatives to enhance healthcare infrastructure, has heightened the need for efficient medical packaging solutions. Asia Pacific also benefits from cost-effective manufacturing, abundant raw material availability, and growing investments by global packaging companies. Moreover, advancements in medical technology and rising awareness regarding hygiene and safety further support the widespread adoption of high-performance medical packaging films. China Market Trends China leads the region with its strong pharmaceutical manufacturing base and vast healthcare sector. Government initiatives like "Healthy China 2030" and heavy investments in medical infrastructure have significantly boosted demand for advanced medical packaging. Local production capabilities and export-oriented packaging manufacturing also support market dominance. India Market Trends India is rapidly emerging as a pharmaceutical hub, known for cost-effective generic drug production and growing exports. The government's 'Make in India' initiative and increasing investments in healthcare infrastructure have accelerated the need for reliable, sterile packaging films. Japan Market Trends Japan contributes significantly due to its advanced medical technology, aging population, and high standards for medical safety and hygiene. The country's focus on innovation and quality compliance drives the demand for high-barrier and multi-layer medical packaging films. South Korea Market Trends South Korea has a well-developed healthcare system and a strong pharmaceutical R&D ecosystem. The country's focus on high-end medical devices and precision packaging solutions enhances demand for advanced medical packaging films. Australia Market Trends Australia's market growth is supported by a stable healthcare system, rising health awareness, and regulatory alignment with global standards. Demand for sustainable and recyclable packaging is also gaining traction here. How is the Opportunistic Rise of North America in the Medical Packaging Films Market? North America is experiencing rapid growth in the medical packaging films market, driven by its highly advanced healthcare infrastructure, increasing pharmaceutical production, and the strong presence of global medical device manufacturers. The region's strict regulatory standards, including those from the FDA, drive the adoption of high-quality, sterile, and compliant packaging solutions. Rising demand for innovative drug delivery systems, an aging population, and the growing prevalence of chronic diseases further fuel the need for reliable and protective packaging. Additionally, continuous R&D investments, a focus on sustainability, and the adoption of smart and antimicrobial packaging technologies are accelerating market expansion in the region. U.S. Market Trends The U.S. is the largest contributor to market growth in North America, owing to its robust pharmaceutical and healthcare industries. High demand for advanced medical devices, strict FDA regulations, and strong R&D activities encourage the use of innovative, compliant, and sterile packaging films. The growing elderly population and rising chronic disease burden further support sustained demand. Canada Market Trends Canada's well-established healthcare system, along with government support for pharmaceutical innovation and public health infrastructure, is driving growth in the medical packaging films sector. Emphasis on sustainability and patient safety is also promoting the adoption of high-barrier and recyclable packaging films. How Big is the Success of the European Medical Packaging Films Market? Europe is experiencing notable growth in the medical packaging films market due to its well-established pharmaceutical and healthcare sectors, along with stringent regulatory frameworks that demand high-quality, sterile, and safe packaging solutions. The increasing aging population and rising prevalence of chronic diseases are boosting the consumption of pharmaceuticals and medical devices, thereby driving packaging needs. Technological advancements in barrier films, sustainability-driven innovations, and the adoption of recyclable and bio-based materials are also key contributors. Additionally, the strong presence of major packaging manufacturers, government healthcare initiatives, and rising export of medical products further support the region's steady market expansion. How Crucial is the Role of Latin America in the Medical Packaging Films Market? Latin America is growing at a considerable rate in the medical packaging films market due to improving healthcare infrastructure, increasing pharmaceutical production, and rising demand for affordable medical solutions. Countries like Brazil and Mexico are expanding their domestic healthcare services, leading to higher consumption of packaged drugs and medical devices. Government initiatives to enhance public health systems and attract foreign investment in pharmaceutical manufacturing are further fueling market growth. Additionally, the growing awareness of hygiene, patient safety, and the need for sterilized packaging is driving the adoption of high-barrier and flexible medical films across hospitals, clinics, and diagnostic centers in the region. How does the Middle East and Africa lead the Medical Packaging Films Market? The Middle East and Africa support the growth of the medical packaging films market through ongoing improvements in healthcare infrastructure, increased government spending on public health, and the rising burden of chronic and infectious diseases. Countries like the UAE, Saudi Arabia, and South Africa are witnessing growing demand for pharmaceuticals and medical devices, which in turn drives the need for high-quality, sterile packaging solutions. The region's push to localize pharmaceutical manufacturing and reduce reliance on imports is attracting investments in packaging Outlook Material Insights The polypropylene packaging segment was dominant in the medical packaging films market in 2024 and is expected to grow at the fastest CAGR in the coming years due to its exceptional material properties and suitability for healthcare applications. Polypropylene offers excellent chemical resistance, high thermal stability, and superior moisture barrier properties, making it ideal for protecting medical devices, surgical instruments, and pharmaceutical products. Its ability to withstand high-temperature sterilization methods like autoclaving enhances its suitability for healthcare applications that demand sterility. Additionally, polypropylene is lightweight, durable, and recyclable, aligning with the increasing focus on sustainable and eco-friendly packaging solutions. Its compatibility with advanced packaging techniques such as thermoforming and metallization further boosts its demand. Type Insights The thermoformable packaging segment holds a dominant position in the medical packaging films market due to its exceptional versatility, product protection, and compatibility with various healthcare applications. Thermoformable films can be easily molded into customized shapes and sizes, making them ideal for packaging surgical instruments, medical trays, diagnostic devices, and implants. They offer strong barrier properties against moisture, oxygen, and contaminants, ensuring the sterility and integrity of medical products throughout storage and transportation. Moreover, thermoformable packaging supports a wide range of materials such as polypropylene and polyvinyl chloride, which can be sterilized using methods like ethylene oxide or gamma radiation. Its cost-effectiveness, ease of handling, and ability to provide tamper-evident and clear visual inspection features make it the preferred choice for both manufacturers and healthcare providers, driving its dominance in the medical packaging films market. The barrier films segment is the fastest-growing segment in the medical packaging films market due to the rising need for enhanced protection and extended shelf life of sensitive medical and pharmaceutical products. These films offer superior resistance to moisture, oxygen, UV light, and other external contaminants, which is critical for preserving the sterility and efficacy of medical devices, drugs, and diagnostic products. As the global demand for biologics, vaccines, and high-value pharmaceuticals increases, particularly those requiring cold chain logistics, the need for high-barrier packaging solutions is accelerating. Barrier films also support advanced materials like metallized films and multilayer laminates, combining strength, flexibility, and performance. Their compatibility with various sterilization methods and sustainability-driven innovations further contributes to their rapid adoption across hospitals, clinics, and pharmaceutical industries. Application Insights The bag segment is the dominant application segment in the medical packaging films market due to its extensive use in storing and transporting a wide range of sterile medical products. Medical bags are essential for packaging items such as intravenous (IV) fluids, blood products, drainage devices, and surgical supplies. These bags provide excellent barrier protection against moisture, oxygen, and contaminants, helping maintain sterility and product integrity. They are also compatible with various sterilization methods like autoclaving and gamma radiation, making them ideal for hospital and clinical settings. Additionally, medical bags are flexible, lightweight, and easy to handle, which enhances convenience and reduces the risk of contamination. The rising demand for disposable, hygienic, and safe medical packaging solutions, especially in the wake of increasing healthcare procedures and infectious disease control, continues to drive the dominance of the bag segment in the market. The tubes application segment is the fastest-growing area in the medical packaging films market, driven by several key factors that reflect its critical role in healthcare delivery. Tubes used to pack items such as ointments, creams, gels, and topical medications demand films with exceptional barrier performance and puncture resistance to preserve product sterility, prevent contamination, and maintain structural integrity during handling and transport. Additionally, the segment benefits from compatibility with diverse sterilization methods (e.g., ethylene oxide, gamma irradiation) and stringent regulatory requirements that prioritize patient safety and drug efficacy. Tubes also align with increasing consumer and clinical preference for convenient, hygienic, and tamper-evident dosage formats, which are easier to use, dispense, and store. Finally, manufacturing innovations in film extrusion and multilayer structures have made high-barrier, flexible films more cost-effective for Breakthroughs in the Market: In June 2025, Honeywell declared that its Evercare pharmaceutical brand will use Aclar film, which was chosen by Evertis, a top manufacturer of packaging film. As the industry works to transition to recyclable solutions, Evertis' assortment of Aclar films will help guarantee that patients everywhere get the life-saving drugs they require in safe packaging. In June 2024, Evertis introduces the Evercare M brand of medical-grade films intended to support regulatory compliance and offer the healthcare industry excellent performance. Over 65 years of reliable technical expertise in creating PET and PEG films for regulated applications that satisfy sustainability standards form the foundation of Evercare M. In May 2025, Jindal Poly Films (JPFL) is spending INR 700 crore to expand its facility in Nashik in order to increase production of BOPP, PET, and CPP films - all of which are essential for pharmaceutical and medical packaging. JPFL hopes to strengthen its position in the flexible packaging industry with this development, and additional production lines should be up and running in two to three years. Top Medical Packaging Films Market Players Amcor Berry Global Uflex Limited West Pharmaceutical Services Sigma Plastics Group AptarGroup, Inc. Parekhplast India Limited SABIC Innovative Plastics SCHOTT AG SGD Pharma WestRock Honeywell International, Inc. Inteplast Group Corporation Huhtamaki India Ltd Medical Packaging Films Market Segments By Type Thermoformable film Barrier films Metallized film Others By Material Polyethylene (PE) Polypropylene (PP) Polyvinyl chloride (PVC) Polyamide Polyester (PET) Others By Application Bags Tubes Others By Region North America U.S. Canada Europe Germany UK France Italy Spain Sweden Denmark Norway Asia Pacific China Japan India South Korea Thailand Latin America Brazil Mexico Argentina Middle East and Africa (MEA) South Africa UAE Saudi Arabia Kuwait Invest in Premium Global Insights @ If you have any questions, please feel free to contact us at sales@ About Us Towards Packaging is a leading global consulting firm specializing in providing comprehensive and strategic research solutions. With a highly skilled and experienced consultant team, we offer a wide range of services designed to empower businesses with valuable insights and actionable recommendations. We stay abreast of the latest industry trends and emerging markets to provide our clients with an unrivalled understanding of their respective sectors. We adhere to rigorous research methodologies, combining primary and secondary research to ensure accuracy and reliability. Our data-driven approach and advanced analytics enable us to unearth actionable insights and make informed recommendations. We are committed to delivering excellence in all our endeavours. Our dedication to quality and continuous improvement has earned us the trust and loyalty of clients worldwide. Our Trusted Data Partners: Precedence Research | Statifacts |Towards Automotive | Towards Healthcare | Towards Food and Beverages | Towards Chemical and Materials | Towards Consumer Goods | Towards Dental | Towards EV Solutions | Nova One Advisor | Healthcare Web Wire | Packaging Web Wire | Automotive Web Wire For Latest Update Follow Us: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10 hours ago
- Yahoo
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.1,2,3 The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.4,5,6,7,8 "The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease." Data submitted to the FDA as part of the NDA include: Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)e 90 compared to placebo at Week 16.4 A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.5 Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.6 Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.7,8 Comprehensive results are being prepared for presentation at a future medical meeting. Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting. Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.9 Editor's notes: a. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. b. ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. c. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10 e. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11 f. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.9 About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.12 ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.13 ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.14 Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.15,16 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.17,18 About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.19 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.20 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.20 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.21 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.22 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.22,23 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,1 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.2,3 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.24 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.25 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.26,27,28 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis; and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.2 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.3 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.4 Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.5 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.6 Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025.7 Data on file.8 Data on file.9 A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 2025.10 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed July 2025.11 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: Accessed July 2025.12 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: Accessed July 2025.13 A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. Accessed July 2025.14 A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. Accessed July 2025.15 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed July 2025.16 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Accessed July 2025.17 A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. National Psoriasis Foundation. About Psoriasis. Available at: Accessed July 2025.20 National Psoriasis Foundation. Psoriasis Statistics. Available at: Accessed July 2025.21 National Psoriasis Foundation. Plaque Psoriasis. Available at: Accessed July 2025.22 National Psoriasis Foundation. Life with Psoriasis. Available at: Accessed July 2025.23 National Psoriasis Foundation. High Impact Sites. Available at: Accessed July 2025.24 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.25 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: Accessed July 2025.26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: Accessed July 2025.27 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: Accessed July 2025.28 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: Accessed July 2025. Media contact: Meg Farina mfarina@ Investor contact: Lauren Johnson investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
