Ulcerative Colitis Clinical Trials Analysis 2025: Advancing Biologics, Small Molecules, and Next-Generation Immunotherapies to Transform Care | DelveInsight

DelveInsight's "Ulcerative Colitis - Clinical Trials Analysis, 2025" reviews the expanding landscape of therapies in development for ulcerative colitis (UC), a chronic inflammatory bowel disease that continues to impose substantial morbidity worldwide. While anti-TNF biologics, JAK inhibitors, and S1P modulators have reshaped treatment in recent years, many patients with moderate-to-severe UC remain refractory, underscoring persistent unmet needs.

The UC clinical trial space is rapidly evolving, with next-generation IL-23 and TYK2 inhibitors, selective JAK agents, and gut-targeted S1P modulators leading innovation. Alongside these targeted approaches, novel modalities such as microbiome-directed therapies, mesenchymal stem cell treatments, and advanced small molecules are under investigation to achieve deeper and more durable remission. Combination regimens and head-to-head trials are also gaining momentum, aiming to optimize sequencing and improve outcomes in biologic-experienced populations.

With several late-stage programs advancing, particularly IL-23 antagonists and selective kinase inhibitors, the UC treatment paradigm is poised for a major shift. Precision-driven, oral, and immune-selective strategies are expected to enhance efficacy, improve safety, and expand long-term remission rates, ultimately transforming the care landscape for patients living with this chronic inflammatory condition.

Interested in learning more about the current treatment landscape and the key drivers shaping the Ulcerative Colitis pipeline? Click here: https://www.delveinsight.com/report-store/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Ulcerative Colitis Pipeline Report
• DelveInsight's ulcerative colitis pipeline analysis depicts a robust space with 70+ active players working to develop 75+ pipeline drugs for ulcerative colitis treatment.
• The leading ulcerative colitis companies include 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 are evaluating their lead assets to improve the ulcerative colitis treatment landscape.
• Key ulcerative colitis pipeline therapies in various stages of development include VTX002, Vixarelimab, TEV-48574, Spesolimab, SOR102, SHR0302, RPC1063, Rosnilimab, R-3750, MK-7240, ALTB-268, ABBV-668, IMU-838, KSP-0243, LMT503, MORF-057, OST-122, PL8177, Etrasimod, Description, Ivarmacitinib, Cobitolimod, TREMFYA, Omilancor, PRA023, Remestemcel-L, Ritlecitinib, Brepocitinib, and others.
• In July 2025, the FDA accepted the Biologics License Application (BLA) for BAT2506, a proposed biosimilar to SIMPONI (golimumab), submitted by Accord BioPharma on behalf of Bio-Thera Solutions. BAT2506 targets multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The FDA's goal date for review is May 16, 2026, and the application also seeks interchangeable status with Simponi.
• In May 2025, ALPCO announced the European launch of its Calprotectin Immunoturbidimetric Assay to support the diagnosis of inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Already FDA-cleared and IVDD-certified, the assay helps distinguish IBD from irritable bowel syndrome (IBS) when used with other clinical data.
• In May 2025, Teva Pharmaceuticals and Alvotech announced that the FDA approved SELARSDITM (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). Starting April 30, 2025, SELARSDI is available in all presentations matching the reference product, for the treatment of adults and pediatric patients with psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.
• In January 2025, Eli Lilly and Company (NYSE: LLY) announced that the FDA approved OMVOH (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults. Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), after its approval in October 2023 as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.
• In January 2025, Rise Therapeutics announced that the FDA accepted its IND application to begin a Phase I cancer trial for R-5780, marking the company's fourth clinical program. Ongoing studies for other products are focused on ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.

Request a sample and discover the recent breakthroughs happening in the ulcerative colitis pipeline landscape @ https://www.delveinsight.com/report-store/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ulcerative Colitis Overview
Ulcerative Colitis is a chronic inflammatory bowel disease (IBD) characterized by inflammation and ulceration of the innermost lining of the large intestine (colon) and r3ctum. It typically causes symptoms such as abdominal pain, persistent diarrhea often with blood or pus, urgency to defecate, and weight loss. The exact cause of UC is unknown but involves an abnormal immune response in genetically susceptible individuals, potentially triggered by environmental factors. Diagnosis is made through clinical evaluation, endoscopy with biopsy, and imaging studies. Treatment focuses on reducing inflammation and managing symptoms using medications like aminosalicylates, corticosteroids, immunomodulators, and biologics. In severe cases, surgery to remove the colon may be necessary. UC is a relapsing condition requiring ongoing management to improve quality of life and reduce complications.

Find out more about ulcerative colitis medication @ https://www.delveinsight.com/report-store/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ulcerative Colitis Treatment Analysis: Drug Profile
Obefazimod: Abivax
Obefazimod is an oral small-molecule drug candidate developed for moderately to severely active ulcerative colitis (UC). It has shown promising anti-inflammatory effects in preclinical studies and Phase IIa and IIb clinical trials. The drug is currently advancing through Phase III clinical trials for UC treatment.

ABBV-668: AbbVie
ABBV-668 is being developed to treat ulcerative colitis, Crohn's disease, and other unspecified immunological disorders. It works by inhibiting receptor interacting serine/threonine protein kinase 1 (RIPK1) and is administered orally. ABBV-668 is currently in Phase II clinical trials for ulcerative colitis.

TEV-48574: Teva Pharmaceutical
TEV-48574, also known as Anti-TL1A (TEV-'574), is a human IgG1 monoclonal antibody targeting TNF-like ligand 1A (TL1A), which plays a key role in driving inflammation and fibrosis in asthma and inflammatory bowel disease (IBD). By inhibiting TL1A, TEV-48574 aims to reduce the overactive immune response seen in ulcerative colitis and Crohn's disease. The drug is currently in Phase IIb clinical trials for ulcerative colitis. Its safety and efficacy are yet to be reviewed by regulatory authorities.

Learn more about the novel and emerging ulcerative colitis pipeline therapies @ https://www.delveinsight.com/report-store/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ulcerative Colitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Ulcerative Colitis Pipeline Report
• Coverage: Global
• Key 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.
• Key Ulcerative Colitis Pipeline Therapies: Etrasimod, Description, Ivarmacitinib, Cobitolimod, TREMFYA, Omilancor, PRA023, Remestemcel-L, ritlecitinib, brepocitinib, ABBV-668, TEV-48574, SOR102, and others.

Dive deep into rich insights for drugs used for ulcerative colitis treatment; visit @ https://www.delveinsight.com/report-store/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Ulcerative Colitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Ulcerative Colitis Pipeline Therapeutics
6. Ulcerative Colitis Pipeline: Late-Stage Products (Phase III)
7. Ulcerative Colitis Pipeline: Late-Stage Products (Phase III)
8. Ulcerative Colitis Pipeline: Mid-Stage Products (Phase II)
9. Ulcerative Colitis Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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.

This release was published on openPR.