Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice

Savika Bansal; Omesh Goyal; Manjeet Kumar Goyal

doi:doi:10.11648/j.iji.20251304.11

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Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice

Savika Bansal

, Omesh Goyal^*

, Manjeet Kumar Goyal

Published in International Journal of Immunology (Volume 13, Issue 4)

Received: 29 September 2025 Accepted: 28 October 2025 Published: 3 December 2025

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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.

Published in	International Journal of Immunology (Volume 13, Issue 4)
DOI	10.11648/j.iji.20251304.11
Page(s)	77-89
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2025. Published by Science Publishing Group

Keywords

Ozanimod, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, S1P Receptor Modulator, Sphingosine-1-phosphate

References

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APA Style

Bansal, S., Goyal, O., Goyal, M. K. (2025). Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. International Journal of Immunology, 13(4), 77-89. https://doi.org/10.11648/j.iji.20251304.11

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ACS Style

Bansal, S.; Goyal, O.; Goyal, M. K. Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. Int. J. Immunol. 2025, 13(4), 77-89. doi: 10.11648/j.iji.20251304.11

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AMA Style

Bansal S, Goyal O, Goyal MK. Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. Int J Immunol. 2025;13(4):77-89. doi: 10.11648/j.iji.20251304.11

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@article{10.11648/j.iji.20251304.11,
  author = {Savika Bansal and Omesh Goyal and Manjeet Kumar Goyal},
  title = {Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice
},
  journal = {International Journal of Immunology},
  volume = {13},
  number = {4},
  pages = {77-89},
  doi = {10.11648/j.iji.20251304.11},
  url = {https://doi.org/10.11648/j.iji.20251304.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.iji.20251304.11},
  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.
},
 year = {2025}
}

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TY  - JOUR
T1  - Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice

AU  - Savika Bansal
AU  - Omesh Goyal
AU  - Manjeet Kumar Goyal
Y1  - 2025/12/03
PY  - 2025
N1  - https://doi.org/10.11648/j.iji.20251304.11
DO  - 10.11648/j.iji.20251304.11
T2  - International Journal of Immunology
JF  - International Journal of Immunology
JO  - International Journal of Immunology
SP  - 77
EP  - 89
PB  - Science Publishing Group
SN  - 2329-1753
UR  - https://doi.org/10.11648/j.iji.20251304.11
AB  - 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.

VL  - 13
IS  - 4
ER  -

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Author Information

Savika Bansal

Department of Medicine, Government Medical College and Rajindra Hospital, Patiala, India

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http://orcid.org/0009-0006-6397-5405
Omesh Goyal

Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India

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http://orcid.org/0000-0002-6347-0988
Manjeet Kumar Goyal

Department of Internal Medicine, Cleveland Clinic Akron General Hospital, Akron, The United States

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http://orcid.org/0000-0002-5511-2099

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Bansal, S., Goyal, O., Goyal, M. K. (2025). Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. International Journal of Immunology, 13(4), 77-89. https://doi.org/10.11648/j.iji.20251304.11

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Bansal, S.; Goyal, O.; Goyal, M. K. Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. Int. J. Immunol. 2025, 13(4), 77-89. doi: 10.11648/j.iji.20251304.11

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AMA Style

Bansal S, Goyal O, Goyal MK. Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice. Int J Immunol. 2025;13(4):77-89. doi: 10.11648/j.iji.20251304.11

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@article{10.11648/j.iji.20251304.11,
  author = {Savika Bansal and Omesh Goyal and Manjeet Kumar Goyal},
  title = {Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice
},
  journal = {International Journal of Immunology},
  volume = {13},
  number = {4},
  pages = {77-89},
  doi = {10.11648/j.iji.20251304.11},
  url = {https://doi.org/10.11648/j.iji.20251304.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.iji.20251304.11},
  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.
},
 year = {2025}
}

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TY  - JOUR
T1  - Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice

AU  - Savika Bansal
AU  - Omesh Goyal
AU  - Manjeet Kumar Goyal
Y1  - 2025/12/03
PY  - 2025
N1  - https://doi.org/10.11648/j.iji.20251304.11
DO  - 10.11648/j.iji.20251304.11
T2  - International Journal of Immunology
JF  - International Journal of Immunology
JO  - International Journal of Immunology
SP  - 77
EP  - 89
PB  - Science Publishing Group
SN  - 2329-1753
UR  - https://doi.org/10.11648/j.iji.20251304.11
AB  - 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.

VL  - 13
IS  - 4
ER  -

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