Review Article
Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice
Issue:
Volume 13, Issue 4, December 2025
Pages:
77-89
Received:
29 September 2025
Accepted:
28 October 2025
Published:
3 December 2025
DOI:
10.11648/j.iji.20251304.11
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Abstract: Background: Ozanimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, represents the first-in-class oral small molecule therapy approved for ulcerative colitis (UC), marking a paradigm shift in inflammatory bowel disease (IBD) management. Objective: To comprehensively review ozanimod therapy in IBD, evaluating its mechanism of action, clinical efficacy, safety profile, real-world experience, and practical implementation considerations through systematic analysis of available evidence. Methods: A systematic literature review was conducted using verified clinical trial data, observational studies, and regulatory documents from January 2016 to August 2025. Studies included randomized controlled trials, real-world evidence publications, safety analyses, and mechanistic studies. Key search terms included "ozanimod," "S1P receptor modulator," "ulcerative colitis," "Crohn's disease," and "inflammatory bowel disease." Results: Analysis of clinical trials revealed that ozanimod demonstrated significant efficacy in phase 3 UC trials, with clinical remission rates of 18.4% versus 6.0% (placebo) at week 10 and 37.0% versus 18.5% at week 52. Advanced therapy-naive patients showed enhanced responses (56% vs 39% symptomatic response by week 2). Real-world studies confirmed effectiveness in treatment-refractory populations with clinical response rates of 44-58% at week 10. The safety profile was favorable with predictable adverse events and no new safety signals in long-term follow-up. Conclusions: Ozanimod represents a significant advancement in IBD therapy, offering an oral, well-tolerated treatment option with unique mechanism of action. Enhanced efficacy in treatment-naive patients supports early positioning in treatment algorithms before biologics.
Abstract: Background: Ozanimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, represents the first-in-class oral small molecule therapy approved for ulcerative colitis (UC), marking a paradigm shift in inflammatory bowel disease (IBD) management. Objective: To comprehensively review ozanimod therapy in IBD, evaluating its mechanism of action,...
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,
Omesh Goyal*
