Ulcerative Colitis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

Ulcerative Colitis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight’s, “Ulcerative Colitis Pipeline Insight” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Ulcerative Colitis pipeline landscape. It covers the Ulcerative Colitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Ulcerative Colitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Ulcerative Colitis pipeline products in this space.

 

Stay ahead with the latest insights! Download DelveInsight’s comprehensive Ulcerative Colitis Pipeline Report to explore emerging therapies, key Ulcerative Colitis Companies, and future Ulcerative Colitis treatment landscapes @ Ulcerative Colitis Pipeline Outlook Report

 

Key Takeaways from the Ulcerative Colitis Pipeline Report

  • In February 2025:- Boehringer Ingelheim:- This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.
  • In February 2025:- Janssen Research & Development LLC:- The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
  • In January 2025:- Eli Lilly and Company:- The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC). The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
  • In January 2025:- AbbVie:- Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed.
  • In January 2025:- Genentech Inc:- The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
  • In January 2025:- Bristol-Myers Squibb;- The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.
  • DelveInsight’s Ulcerative Colitis pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Ulcerative Colitis treatment.
  • The leading Ulcerative Colitis Companies such as Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others
  • Promising Alpha-1 Antitrypsin Deficiency Pipeline Therapies such as VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others.

 

Discover how the Ulcerative Colitis treatment paradigm is evolving. Access DelveInsight’s in-depth Ulcerative Colitis Pipeline Analysis for a closer look at promising breakthroughs @ Ulcerative Colitis Clinical Trials and Studies

 

Ulcerative Colitis Emerging Drugs Profile

  • Obefazimod: Abivax

Obefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis.

 

  • ABBV-668: AbbVie

ABBV-668 is under development for the treatment of crohn’s disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.

 

  • TEV-48574: Teva Pharmaceutical

Anti-TL1A (TEV-’574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-’574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-’574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn’s disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-’574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.

 

  • SOR102: Sorriso Pharmaceuticals

SOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis.

 

The Ulcerative Colitis pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Ulcerative Colitis 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 Ulcerative Colitis Treatment.
  • Ulcerative Colitis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Ulcerative Colitis 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 Ulcerative Colitis market.

 

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Ulcerative Colitis Companies

Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others

 

Ulcerative Colitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

 

Ulcerative Colitis Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

 

Download DelveInsight’s latest report to gain strategic insights into upcoming Ulcerative Colitis Therapies and key Ulcerative Colitis Developments @ Ulcerative Colitis Market Drivers and Barriers, and Future Perspectives

 

Scope of the Ulcerative Colitis Pipeline Report

  • Coverage- Global
  • Ulcerative Colitis Companies- Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others
  • Alpha-1 Antitrypsin Deficiency Pipeline Therapies– VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others.
  • Ulcerative Colitis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Ulcerative Colitis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

Which companies are leading the race in Ulcerative Colitis drug development? Find out in DelveInsight’s exclusive Ulcerative Colitis Pipeline Report—access it now! @ Ulcerative Colitis Emerging Drugs and Major Companies

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Ulcerative Colitis: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Ulcerative Colitis– DelveInsight’s Analytical Perspective
  7. In-depth Commercial Assessment
  8. Ulcerative Colitis Collaboration Deals
  9. Late Stage Products (Preregistration)
  10. Mirikizumab: Eli Lilly and Company
  11. Drug profiles in the detailed report…..
  12. Late Stage Products (Phase III)
  13. Obefazimod: Abivax
  14. Drug profiles in the detailed report…..
  15. Mid Stage Products (Phase II)
  16. ABBV-668: AbbVie
  17. Drug profiles in the detailed report…..
  18. Early Stage Products (Phase I)
  19. SOR102: Sorriso Pharmaceuticals
  20. Drug profiles in the detailed report…..
  21. Preclinical Stage Products
  22. Drug Name: Company Name
  23. Drug profiles in the detailed report…..
  24. Inactive Products
  25. Ulcerative Colitis Key Companies
  26. Ulcerative Colitis Key Products
  27. Ulcerative Colitis- Unmet Needs
  28. Ulcerative Colitis- Market Drivers and Barriers
  29. Ulcerative Colitis- Future Perspectives and Conclusion
  30. Ulcerative Colitis Analyst Views
  31. Ulcerative Colitis Key Companies
  32. Appendix

 

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