Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by inflammation and ulceration of the colon and rectum. According to Catherine Le Berre et al., 2023, the global prevalence of ulcerative colitis was approximately 5 million cases in 2023, with incidence rising worldwide. The UC drug pipeline includes biologics, small molecules, and novel therapies targeting inflammatory pathways and immune modulation. According to the ulcerative colitis pipeline analysis by Expert Market Research, there is a growing focus on personalized treatment approaches, improved efficacy, and reduced side effects. The pipeline’s expansion is expected to drive significant market growth in the coming years.
Major companies involved in the ulcerative colitis pipeline analysis include Eli Lilly and Company, Accro Bioscience (Suzhou) Limited, and others.
Leading drugs currently in the pipeline include AC-101, ABX464, PF-07054894, and others.
The pipeline is poised for growth due to the development of targeted biologics and novel small-molecule therapies, alongside increasing clinical trials focusing on personalized treatment and improved safety profiles.
The Ulcerative Colitis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into ulcerative colitis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for ulcerative colitis. The ulcerative colitis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The ulcerative colitis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with ulcerative colitis treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to ulcerative colitis.
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Ulcerative colitis is a chronic inflammatory bowel disease affecting the colon and rectum, characterized by persistent inflammation and ulcer formation in the intestinal lining. It arises from a combination of genetic factors, abnormal immune responses, and environmental triggers, causing the immune system to attack the colon. Common symptoms include abdominal pain, diarrhea, rectal bleeding, fatigue, and urgent bowel movements, which can severely affect quality of life. Rising global prevalence underscores the need for effective management to prevent complications such as severe bleeding, colon perforation, and increased colorectal cancer risk.
Treatment for ulcerative colitis aims to control inflammation, induce remission, and maintain long-term disease management. Standard therapies include anti-inflammatory drugs, immunosuppressants, biologics, and emerging targeted treatments, all designed to alleviate symptoms, improve daily functioning, and prevent disease progression. In October 2023, the FDA approved mirikizumab, a breakthrough therapy targeting interleukin-23, for moderate-to-severe ulcerative colitis. Clinical trials demonstrated its effectiveness in both induction and maintenance phases, achieving significant clinical remission and reducing bowel urgency, offering patients a safer and more effective long-term treatment option.
According to Catherine Le Berre et al., 2023, the global prevalence of ulcerative colitis (UC) is estimated at 5 million cases, with incidence rising steadily worldwide. As per Gastroenterology Advisor, over 2.39 million Americans are affected by inflammatory bowel disease (IBD), including 1.25 million with UC, and more than 0.7% of Americans are expected to be diagnosed with IBD during their lifetime. According to Mehmet A. Veral et al., 2025, approximately 3.9 million females and 3 million males are affected by IBD globally, with Europe reporting around 0.2% prevalence and the United Kingdom among the countries with the highest incidence and prevalence rates. As per Ulcerative Colitis (UC) Epidemiology Report by Expert Market Research, 14-35% of UC patients present with pancolitis, 16-45% with left-sided colitis, and 30–60% with proctitis. These epidemiological trends underscore the increasing need for novel and effective UC therapies.
This section of the report covers the analysis of ulcerative colitis drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The ulcerative colitis pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II with 42% covers a major share of the total ulcerative colitis clinical trials, reflecting strong clinical development activity and promising therapeutic innovations. Phase III contributes 27%, indicating advanced-stage candidates nearing regulatory approval. Phase I holds 17%. This balanced pipeline supports sustained market growth and expands treatment options.
The drug molecule categories covered under the ulcerative colitis pipeline analysis include small molecules, monoclonal antibodies, recombinant proteins, oligonucleotides, and peptides. The ulcerative colitis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for ulcerative colitis. Targeted oral peptide therapies are emerging in the ulcerative colitis drug pipeline to provide innovative treatment options. For instance, in October 2025, Johnson & Johnson announced that Icotrokinra, a first-in-class oral peptide that selectively blocks the IL-23 receptor, showed promising results in the Phase 2b ANTHEM-UC study. Once-daily dosing achieved significant clinical response, symptomatic remission, and endoscopic improvement, highlighting its potential as a safe and effective therapy for moderately to severely active ulcerative colitis.
The EMR report for the ulcerative colitis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed ulcerative colitis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in ulcerative colitis clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for ulcerative colitis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of ulcerative colitis drug candidates.
AC-101, sponsored by Accro Bioscience (Suzhou) Limited, is a novel RIPK2 inhibitor currently being evaluated in participants with moderate to severe active ulcerative colitis. This Phase 1b study is recruiting approximately 24 participants and is designed to examine the safety, efficacy, and pharmacokinetics of AC-101 tablets. The total study duration spans up to 17 weeks, including a 4-week screening period, 12 weeks of treatment, and a 1-week safety follow-up. AC-101 is being developed as a non-immunosuppressive therapy targeting inflammatory pathways, aiming to reduce intestinal inflammation while minimizing systemic immune suppression. The study is providing critical early data on the drug’s therapeutic potential.
ABX464 (obefazimod) is a first-in-class oral quinoline molecule developed by Abivax S.A., currently being evaluated for the long-term treatment of moderate to severe active ulcerative colitis. This Phase II open-label study is actively assessing the safety and efficacy profile of ABX464 administered once daily at 25 mg in subjects previously enrolled in ABX464-102 or ABX464-104 trials. The study is examining the drug’s ability to maintain clinical remission, reduce inflammatory markers, and promote endoscopic improvement over a treatment period of up to 54 months, followed by a four-week safety follow-up. ABX464 selectively upregulates the anti-inflammatory micro-RNA miR-124, leading to decreased proinflammatory cytokines such as IL-17 and IL-6, while demonstrating durable efficacy in patients intolerant or refractory to conventional therapies.
PF-07054894, an oral CCR6 antagonist, is being developed by Pfizer for the treatment of ulcerative colitis. The drug is designed as a first-in-class therapy targeting the G protein-coupled receptor CCR6, which regulates the migration of pathogenic immune cells to sites of inflammation. By blocking CCR6, PF-07054894 is expected to reduce immune cell recruitment and control chronic inflammation in the colon. The ongoing Phase 1b study is actively examining the safety, efficacy, and pharmacokinetics of the drug in adult participants aged 18 to 75 with mild to severe ulcerative colitis. This randomized, double-blind, placebo-controlled, multicenter trial is enrolling 40 participants and aims to provide critical insights for further clinical development.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Ulcerative Colitis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for ulcerative colitis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into ulcerative colitis collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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