Ulcerative Colitis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Ulcerative Colitis Pipeline Insight 2025" 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 pipeline products in this space.

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Key Takeaways from the Ulcerative Colitis Pipeline Report

* In April 2025, Merck Sharp & Dohme LLC announced a study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.
* In April 2025, Janssen Research & Development, LLC announced a 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).
* 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 Ulcerative Colitis therapies such as VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others.

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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.

* 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

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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.
* Ulcerative Colitis 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

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Table of Content

* Introduction
* Executive Summary
* Ulcerative Colitis: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Ulcerative Colitis- DelveInsight's Analytical Perspective
* In-depth Commercial Assessment
* Ulcerative Colitis Collaboration Deals
* Late Stage Products (Preregistration)
* Mirikizumab: Eli Lilly and Company
* Drug profiles in the detailed report.....
* Late Stage Products (Phase III)
* Obefazimod: Abivax
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* ABBV-668: AbbVie
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* SOR102: Sorriso Pharmaceuticals
* Drug profiles in the detailed report.....
* Preclinical Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* Ulcerative Colitis Key Companies
* Ulcerative Colitis Key Products
* Ulcerative Colitis- Unmet Needs
* Ulcerative Colitis- Market Drivers and Barriers
* Ulcerative Colitis- Future Perspectives and Conclusion
* Ulcerative Colitis Analyst Views
* Ulcerative Colitis Key Companies
* Appendix

About Us

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