Crohn's Disease Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Crohn's Disease pipeline constitutes 40+ key companies continuously working towards developing 50+ Crohn's Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.
' Crohn's Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Crohn's Disease Market.
Crohn's disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract, causing inflammation anywhere from the mouth to the anus, but most commonly in the small intestine and the beginning of the large intestine (colon). It belongs to a group of conditions known as inflammatory bowel diseases (IBD).
Some of the key takeaways from the Crohn's Disease Pipeline Report:
Companies across the globe are diligently working toward developing novel Crohn's Disease treatment therapies with a considerable amount of success over the years.
Crohn's Disease companies working in the treatment market are Morphic Therapeutic, Orchard Therapeutics, Thetis Pharmaceuticals, AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, Bristol-Myers Squibb, Eisai Inc, Janssen Pharmaceutical, Eli Lilly and Company, Gilead Sciences, RedHill Biopharma, Celgene Corporation, AstraZeneca, and others, are developing therapies for the Crohn's Disease treatment
Emerging Crohn's Disease therapies in the different phases of clinical trials are- MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, Brazikumab, and others are expected to have a significant impact on the Crohn's Disease market in the coming years.
In March 2025, Celltrion announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), after receiving FDA approval in December 2024. STEQEYMA is authorized for the same indications as STELARA, ensuring reliable treatment options for both patients and healthcare providers.
In March 2025, Johnson & Johnson announced that the FDA has approved TREMFYA® (guselkumab), making it the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options for adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition affecting the gastrointestinal tract.
In February 2025, Eli Lilly shared findings from the VIVID-2 open-label extension study at the Crohn's and Colitis Congress (CCC), revealing that most patients with moderately-to-severely active Crohn's disease treated continuously with OMVOH for two years achieved sustained clinical and endoscopic outcomes, including 43.8% of patients who had previously failed biologic therapies.
In January 2025, The FDA approved OMVOH (mirikizumab) for Crohn's disease, reinforcing the role of IL-23 inhibitors. Demonstrating robust long-term effectiveness, OMVOH is also under investigation for use in pediatric patients, potentially fulfilling a critical unmet need in this group.
Crohn's Disease Overview
Crohn's Disease is a chronic inflammatory bowel disease (IBD) that causes inflammation of the digestive tract, most commonly affecting the small intestine and the beginning of the colon. It can lead to symptoms such as abdominal pain, diarrhea, fatigue, weight loss, and malnutrition. The exact cause is unknown but is believed to involve an abnormal immune response, genetics, and environmental factors. Crohn's can affect any part of the gastrointestinal tract and may lead to complications like strictures, fistulas, or bowel obstruction. While there is no cure, treatments including medications, dietary changes, and sometimes surgery can help manage symptoms and inflammation.
Emerging Crohn's Disease Drugs Under Different Phases of Clinical Development Include:
MORF 057: Morphic Therapeutic
OTL-104: Orchard Therapeutics
TP-317: Thetis Pharmaceuticals
AZD 7798: AstraZeneca
IMU 856: Immunic
CBP-307: Suzhou Connect Biopharmaceuticals
PF-06651600: Pfizer
Deucravacitinib: Bristol-Myers Squibb
E6011: Eisai Inc
Guselkumab: Janssen Pharmaceutical
Mirikizumab: Eli Lilly and Company
Filgotinib: Gilead Sciences
RHB-104: RedHill Biopharma
Ozanimod: Celgene Corporation
Brazikumab: AstraZeneca
Crohn's Disease Route of Administration
Crohn's Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
Oral
Parenteral
Intravenous
Subcutaneous
Topical
Crohn's Disease Molecule Type
Crohn's Disease Products have been categorized under various Molecule types, such as
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
Crohn's Disease Pipeline Therapeutics Assessment
Crohn's Disease Assessment by Product Type
Crohn's Disease By Stage and Product Type
Crohn's Disease Assessment by Route of Administration
Crohn's Disease By Stage and Route of Administration
Crohn's Disease Assessment by Molecule Type
Crohn's Disease by Stage and Molecule Type
DelveInsight's Crohn's Disease Report covers around 50+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further Crohn's Disease product details are provided in the report. Download the Crohn's Disease pipeline report to learn more about the emerging Crohn's Disease therapies
Some of the key companies in the Crohn's Disease Therapeutics Market include:
Key companies developing therapies for Crohn's Disease are - Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, and others.
Crohn's Disease Pipeline Analysis:
The Crohn's Disease pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Crohn's Disease with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Crohn's Disease Treatment.
Crohn's Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Crohn's Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Crohn's Disease market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Crohn's Disease Pipeline Market Drivers
High prevalence of Crohn's Disease, increase in Drug Development for Crohn's treatment, change in lifestyle patterns are some of the important factors that are fueling the Crohn's Disease Market.
Crohn's Disease Pipeline Market Barriers
However, lack of early diagnosis of the disease, high cost associated with the treatment and other factors are creating obstacles in the Crohn's Disease Market growth.
Scope of Crohn's Disease Pipeline Drug Insight
Coverage: Global
Key Crohn's Disease Companies: Morphic Therapeutic, Orchard Therapeutics, Thetis Pharmaceuticals, AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, Bristol-Myers Squibb, Eisai Inc, Janssen Pharmaceutical, Eli Lilly and Company, Gilead Sciences, RedHill Biopharma, Celgene Corporation, AstraZeneca, and others
Key Crohn's Disease Therapies: MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, Brazikumab, and others
Crohn's Disease Therapeutic Assessment: Crohn's Disease current marketed and Crohn's Disease emerging therapies
Crohn's Disease Market Dynamics: Crohn's Disease market drivers and Crohn's Disease market barriers
Table of Contents
1. Crohn's Disease Report Introduction
2. Crohn's Disease Executive Summary
3. Crohn's Disease Overview
4. Crohn's Disease- Analytical Perspective In-depth Commercial Assessment
5. Crohn's Disease Pipeline Therapeutics
6. Crohn's Disease Late Stage Products (Phase II/III)
7. Crohn's Disease Mid Stage Products (Phase II)
8. Crohn's Disease Early Stage Products (Phase I)
9. Crohn's Disease Preclinical Stage Products
10. Crohn's Disease Therapeutics Assessment
11. Crohn's Disease Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Crohn's Disease Key Companies
14. Crohn's Disease Key Products
15. Crohn's Disease Unmet Needs
16 . Crohn's Disease Market Drivers and Barriers
17. Crohn's Disease Future Perspectives and Conclusion
18. Crohn's Disease Analyst Views
19. Appendix
20. About DelveInsight
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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
Media Contact
Company Name: DelveInsight
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/
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Crohn's Disease Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Crohn's Disease pipeline constitutes 40+ key companies continuously working towards developing 50+ Crohn's Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. ' Crohn's Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Crohn's Disease Market. Crohn's disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract, causing inflammation anywhere from the mouth to the anus, but most commonly in the small intestine and the beginning of the large intestine (colon). It belongs to a group of conditions known as inflammatory bowel diseases (IBD). Some of the key takeaways from the Crohn's Disease Pipeline Report: Companies across the globe are diligently working toward developing novel Crohn's Disease treatment therapies with a considerable amount of success over the years. Crohn's Disease companies working in the treatment market are Morphic Therapeutic, Orchard Therapeutics, Thetis Pharmaceuticals, AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, Bristol-Myers Squibb, Eisai Inc, Janssen Pharmaceutical, Eli Lilly and Company, Gilead Sciences, RedHill Biopharma, Celgene Corporation, AstraZeneca, and others, are developing therapies for the Crohn's Disease treatment Emerging Crohn's Disease therapies in the different phases of clinical trials are- MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, Brazikumab, and others are expected to have a significant impact on the Crohn's Disease market in the coming years. In March 2025, Celltrion announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), after receiving FDA approval in December 2024. STEQEYMA is authorized for the same indications as STELARA, ensuring reliable treatment options for both patients and healthcare providers. In March 2025, Johnson & Johnson announced that the FDA has approved TREMFYA® (guselkumab), making it the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options for adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition affecting the gastrointestinal tract. In February 2025, Eli Lilly shared findings from the VIVID-2 open-label extension study at the Crohn's and Colitis Congress (CCC), revealing that most patients with moderately-to-severely active Crohn's disease treated continuously with OMVOH for two years achieved sustained clinical and endoscopic outcomes, including 43.8% of patients who had previously failed biologic therapies. In January 2025, The FDA approved OMVOH (mirikizumab) for Crohn's disease, reinforcing the role of IL-23 inhibitors. Demonstrating robust long-term effectiveness, OMVOH is also under investigation for use in pediatric patients, potentially fulfilling a critical unmet need in this group. Crohn's Disease Overview Crohn's Disease is a chronic inflammatory bowel disease (IBD) that causes inflammation of the digestive tract, most commonly affecting the small intestine and the beginning of the colon. It can lead to symptoms such as abdominal pain, diarrhea, fatigue, weight loss, and malnutrition. The exact cause is unknown but is believed to involve an abnormal immune response, genetics, and environmental factors. Crohn's can affect any part of the gastrointestinal tract and may lead to complications like strictures, fistulas, or bowel obstruction. While there is no cure, treatments including medications, dietary changes, and sometimes surgery can help manage symptoms and inflammation. Emerging Crohn's Disease Drugs Under Different Phases of Clinical Development Include: MORF 057: Morphic Therapeutic OTL-104: Orchard Therapeutics TP-317: Thetis Pharmaceuticals AZD 7798: AstraZeneca IMU 856: Immunic CBP-307: Suzhou Connect Biopharmaceuticals PF-06651600: Pfizer Deucravacitinib: Bristol-Myers Squibb E6011: Eisai Inc Guselkumab: Janssen Pharmaceutical Mirikizumab: Eli Lilly and Company Filgotinib: Gilead Sciences RHB-104: RedHill Biopharma Ozanimod: Celgene Corporation Brazikumab: AstraZeneca Crohn's Disease Route of Administration Crohn's Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as Oral Parenteral Intravenous Subcutaneous Topical Crohn's Disease Molecule Type Crohn's Disease Products have been categorized under various Molecule types, such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Crohn's Disease Pipeline Therapeutics Assessment Crohn's Disease Assessment by Product Type Crohn's Disease By Stage and Product Type Crohn's Disease Assessment by Route of Administration Crohn's Disease By Stage and Route of Administration Crohn's Disease Assessment by Molecule Type Crohn's Disease by Stage and Molecule Type DelveInsight's Crohn's Disease Report covers around 50+ products under different phases of clinical development like Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Further Crohn's Disease product details are provided in the report. Download the Crohn's Disease pipeline report to learn more about the emerging Crohn's Disease therapies Some of the key companies in the Crohn's Disease Therapeutics Market include: Key companies developing therapies for Crohn's Disease are - Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, and others. Crohn's Disease Pipeline Analysis: The Crohn's Disease pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Crohn's Disease with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Crohn's Disease Treatment. Crohn's Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Crohn's Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Crohn's Disease market. 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Scope of Crohn's Disease Pipeline Drug Insight Coverage: Global Key Crohn's Disease Companies: Morphic Therapeutic, Orchard Therapeutics, Thetis Pharmaceuticals, AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, Bristol-Myers Squibb, Eisai Inc, Janssen Pharmaceutical, Eli Lilly and Company, Gilead Sciences, RedHill Biopharma, Celgene Corporation, AstraZeneca, and others Key Crohn's Disease Therapies: MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, Brazikumab, and others Crohn's Disease Therapeutic Assessment: Crohn's Disease current marketed and Crohn's Disease emerging therapies Crohn's Disease Market Dynamics: Crohn's Disease market drivers and Crohn's Disease market barriers Table of Contents 1. Crohn's Disease Report Introduction 2. Crohn's Disease Executive Summary 3. Crohn's Disease Overview 4. Crohn's Disease- Analytical Perspective In-depth Commercial Assessment 5. Crohn's Disease Pipeline Therapeutics 6. Crohn's Disease Late Stage Products (Phase II/III) 7. Crohn's Disease Mid Stage Products (Phase II) 8. Crohn's Disease Early Stage Products (Phase I) 9. Crohn's Disease Preclinical Stage Products 10. Crohn's Disease Therapeutics Assessment 11. Crohn's Disease Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Crohn's Disease Key Companies 14. Crohn's Disease Key Products 15. Crohn's Disease Unmet Needs 16 . Crohn's Disease Market Drivers and Barriers 17. Crohn's Disease Future Perspectives and Conclusion 18. Crohn's Disease Analyst Views 19. Appendix 20. About DelveInsight 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. 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