Prurigo Nodularis Treatment Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, NDA Approvals, Medication, Prevalence, MOA, Revenue, Statistics and Companies by DelveInsight
Prurigo Nodularis Companies are Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others.
(Albany, USA) DelveInsight's ' Prurigo Nodularis Market Insights, Epidemiology, and Market Forecast-2034 ″ report offers an in-depth understanding of the Prurigo Nodularis, historical and forecasted epidemiology as well as the Prurigo Nodularis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
The Prurigo Nodularis market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Prurigo Nodularis market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Prurigo Nodularis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Prurigo Nodularis market.
Some of the key facts of the Prurigo Nodularis Market Report:
The Prurigo Nodularis market size is anticipated to grow with a significant CAGR during the study period (2020-2034)
In March 2025, Incyte (Nasdaq:INCY) announced results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (≥18 years) with prurigo nodularis (PN). The positive TRuE-PN1 data were presented as a late-breaking oral presentation (Session: S028 – Late-Breaking Research: Session 1) today at the 2025 American Academy of Dermatology (AAD) Annual Meeting, being held March 7–11, 2025, in Orlando.
In February 2025, Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab's subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
In August 2024, Galderma has announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection to treat adults with prurigo nodularis. Nemluvio received Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024, highlighting its potential to significantly enhance treatment for serious conditions.
In March 2024, Incyte revealed recently released late-breaking data from a Phase II study assessing povorcitinib in individuals diagnosed with prurigo nodularis.
According to Morgan et al. (2022), the estimated prevalence of prurigo nodularis was recorded at 3.27 cases per 10,000 patients.
In 2023, among the 7MM, the United States had the largest diagnosed prevalent population of prurigo nodularis.
DUPIXENT (dupilumab) stands as the sole therapeutic approved by the US FDA for the treatment of prurigo nodularis, with several other treatments currently undergoing development.
Key Prurigo Nodularis Companies: Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others
Key Prurigo Nodularis Therapies: Nalbuphine ER, Nemolizumab, Vixarelimab(KPL-716), Povorcitinib(INCB-54707), Ruxolitinib Cream, INCB054707, serlopitant, CC-10004, Pimecrolimus, Abrocitinib, Dupilumab SAR231893, and others
The Prurigo Nodularis epidemiology based on gender analyzed that females are affected more as compared to males, in the case of Prurigo Nodularis
The Prurigo Nodularis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Prurigo Nodularis pipeline products will significantly revolutionize the Prurigo Nodularis market dynamics.
Prurigo Nodularis Overview
Prurigo Nodularis (PN) is a chronic inflammatory skin disorder characterized by the presence of multiple, intensely itchy, firm nodules that develop due to prolonged scratching and skin trauma. The exact cause of Prurigo Nodularis remains unclear, but it is associated with immune system dysregulation, chronic pruritus, nerve abnormalities, and underlying conditions such as atopic dermatitis, diabetes, chronic kidney disease, HIV, and psychiatric disorders.
Prurigo Nodularis Patients experience severe, persistent pruritus (itching), often leading to excoriated, hyperpigmented, or lichenified nodules that typically affect the arms, legs, and trunk. The itch-scratch cycle worsens the condition, making it difficult to treat. Prurigo Nodularis significantly impacts quality of life, causing sleep disturbances, anxiety, depression, and social embarrassment.
Prurigo Nodularis Diagnosis is clinical, based on the characteristic nodules and patient history, but may require skin biopsies, blood tests, or nerve function assessments to rule out underlying conditions. Treatment focuses on breaking the itch-scratch cycle using topical corticosteroids, calcineurin inhibitors, antihistamines, and emollients. In severe cases, biologic therapies (such as IL-31 inhibitors), immunosuppressants, gabapentinoids, and phototherapy may be needed. Recent advancements in targeted biologics and neuromodulators are improving outcomes, offering new hope for long-term disease control and symptom relief in Prurigo Nodularis patients.
Prurigo Nodularis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Prurigo Nodularis Epidemiology Segmentation:
The Prurigo Nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalence of Prurigo Nodularis
Prevalent Cases of Prurigo Nodularis by severity
Gender-specific Prevalence of Prurigo Nodularis
Diagnosed Cases of Episodic and Chronic Prurigo Nodularis
Download the report to understand which factors are driving Prurigo Nodularis epidemiology trends @ Prurigo Nodularis Epidemiology Forecast
Prurigo Nodularis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Prurigo Nodularis market or expected to get launched during the study period. The analysis covers Prurigo Nodularis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Prurigo Nodularis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Prurigo Nodularis Therapies and Key Companies
Nalbuphine ER: Trevi Therapeutics
Nemolizumab: Galderma
Vixarelimab(KPL-716): Genentech
Povorcitinib(INCB-54707): Incyte Corporation
Ruxolitinib Cream: Incyte Corporation
INCB054707: Incyte Corporation
serlopitant: Vyne Therapeutics Inc.
CC-10004: Celgene Corporation
Pimecrolimus: Novartis
Abrocitinib: Pfizer
Dupilumab SAR231893: Regeneron Pharma
Discover more about therapies set to grab major Prurigo Nodularis market share @ Prurigo Nodularis Treatment Market
Prurigo Nodularis Market Strengths
Novel drug formulations are unlocking the new market outlook and the potential to improve the QoL of patients suffering from the serious symptoms associated with chronic neurologically mediated conditions for which there are few, if any, treatment options. Vixarelimab's dual mechanism offers potential pruritus relief and nodule improvement in prurigo nodularis.
Prurigo Nodularis Market Opportunities
Increasing population gives a lucrative opportunity to increase the awareness and innovation of therapeutics to drive the prurigo nodularis market. Due to one approved drug in the market, there is a huge opportunity for the companies who are coming with novel emerging therapies.
Scope of the Prurigo Nodularis Market Report
Study Period: 2020–2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Prurigo Nodularis Companies: Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others
Key Prurigo Nodularis Therapies: Nalbuphine ER, Nemolizumab, Vixarelimab(KPL-716), Povorcitinib(INCB-54707), Ruxolitinib Cream, INCB054707, serlopitant, CC-10004, Pimecrolimus, Abrocitinib, Dupilumab SAR231893, and others
Prurigo Nodularis Therapeutic Assessment: Prurigo Nodularis current marketed and Prurigo Nodularis emerging therapies
Prurigo Nodularis Market Dynamics: Prurigo Nodularis market drivers and Prurigo Nodularis market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Prurigo Nodularis Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement
To know more about Prurigo Nodularis companies working in the treatment market, visit @ P rurigo Nodularis Clinical Trials and Therapeutic Assessment
Table of Contents
1. Prurigo Nodularis Market Report Introduction
2. Executive Summary for Prurigo Nodularis
3. SWOT analysis of Prurigo Nodularis
4. Prurigo Nodularis Patient Share (%) Overview at a Glance
5. Prurigo Nodularis Market Overview at a Glance
6. Prurigo Nodularis Disease Background and Overview
7. Prurigo Nodularis Epidemiology and Patient Population
8. Country-Specific Patient Population of Prurigo Nodularis
9. Prurigo Nodularis Current Treatment and Medical Practices
10. Prurigo Nodularis Unmet Needs
11. Prurigo Nodularis Emerging Therapies
12. Prurigo Nodularis Market Outlook
13. Country-Wise Prurigo Nodularis Market Analysis (2020–2034)
14. Prurigo Nodularis Market Access and Reimbursement of Therapies
15. Prurigo Nodularis Market Drivers
16. Prurigo Nodularis Market Barriers
17. Prurigo Nodularis Appendix
18. Prurigo Nodularis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare 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.
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Company Name: DelveInsight Business Research LLP
Contact Person: Ankit Nigam
Email: Send Email
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
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Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. 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- Cision Canada
Oncolytics Biotech® Names New CEO to Accelerate Momentum in Immunotherapy Programs
SAN DIEGO and CALGARY, AB, June 11, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors. Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics' Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Mr. Kelly added, "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies. In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types. As a material inducement to Mr. Kelly's appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company's then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly's long-term incentives with the creation of shareholder value. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics' belief that pelareorep's consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships; our belief that we will move pelareorep forward effectively and efficiently to a place where prospective partners will see potential value; our plans and strategies to advance pelareorep towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics. ca Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@lifesciadvisors. com
