What are the new drugs for Inflammatory Bowel Disease (IBD)?

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Last updated: May 24, 2025 • View editorial policy

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From the Guidelines

The most effective new drug for the treatment of inflammatory bowel disease (IBD) is ozanimod (Zeposia), an oral S1P receptor modulator, due to its favorable safety profile and efficacy in achieving steroid-free remission, mucosal and histological healing, and reductions in hospitalizations and surgeries 1.

Introduction to New IBD Treatments

Several new drugs have been developed for IBD treatment in recent years, including biologics like ustekinumab (Stelara) and vedolizumab (Entyvio), as well as oral small molecule therapies like ozanimod (Zeposia) and JAK inhibitors like tofacitinib (Xeljanz) and upadacitinib (Rinvoq) 1.

Mechanisms and Administration

These medications work through different mechanisms than traditional TNF-inhibitors, offering alternatives for patients with primary non-response or loss of response to older therapies. Ozanimod, for example, is an oral S1P receptor modulator that starts at 0.23mg daily for 4 days, then 0.46mg for 3 days, followed by a 0.92mg maintenance dose 1.

Treatment Selection and Safety

Treatment selection should be individualized based on disease phenotype, comorbidities, and patient preferences regarding administration route and frequency. While JAK inhibitors like tofacitinib and upadacitinib carry boxed warnings for cardiovascular and malignancy risks, ozanimod has a more favorable safety profile, making it a preferred option for many patients 1.

Key Considerations

When choosing a new drug for IBD treatment, it is essential to consider the patient's disease severity, comorbidities, and preferences. Ozanimod, with its oral administration and favorable safety profile, is an attractive option for many patients, especially those who have failed or lost response to traditional TNF-inhibitors 1.

Recent Guidelines and Studies

Recent studies and guidelines, such as the clinician's guide to using ozanimod for the treatment of ulcerative colitis, highlight the importance of individualized treatment selection and the potential benefits of newer therapies like ozanimod 1. The WSES-AAST guidelines for the management of IBD in the emergency setting also emphasize the need for tailored treatment approaches and the role of newer therapies in improving patient outcomes 1.

From the FDA Drug Label

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a Janus kinase (JAK) inhibitor indicated for: • Ulcerative Colitis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers

Tofacitinib (PO) is used to treat ulcerative colitis in adults who have had an inadequate response or intolerance to one or more TNF blockers 2.

  • The FDA-approved indication for tofacitinib includes moderately to severely active ulcerative colitis.
  • Tofacitinib is a Janus kinase (JAK) inhibitor.
  • It is not recommended to use tofacitinib in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine 2.

From the Research

New Drugs for Inflammatory Bowel Disease (IBD)

  • Tofacitinib, an oral small-molecule Janus kinase inhibitor, has been shown to be effective in the treatment of ulcerative colitis (UC) 3, 4.
  • The OCTAVE studies demonstrated the efficacy and safety of tofacitinib for the induction and maintenance of remission in UC 4.
  • Dual targeted therapy, which combines biologics and/or small molecule drugs, is an emerging concept in the treatment of IBD 5.
  • Biological drugs, such as infliximab and vedolizumab, have been shown to improve health-related quality of life (HRQoL) in patients with IBD 6.
  • A comparison of biologics in the treatment of IBD found that tofacitinib and infliximab had high efficacy rates in Crohn's disease, while infliximab and vedolizumab had high efficacy rates in UC 7.

Mechanism of Action and Efficacy

  • Tofacitinib works by inhibiting Janus kinase, which plays a key role in the immune response 3, 4.
  • Infliximab and vedolizumab work by targeting tumor necrosis factor-alpha (TNF-α) and leukocyte trafficking, respectively 6, 7.
  • The efficacy of these drugs has been demonstrated in clinical trials, with significant improvements in clinical response, remission, and mucosal healing 3, 4, 6, 7.

Safety and Adverse Events

  • The safety profiles of these drugs have been evaluated in clinical trials, with common adverse events including infections and infestations 7.
  • The combined percentage of adverse events was highest with infliximab and least with ozanimod 7.
  • Further studies are needed to fully evaluate the safety and efficacy of these drugs in the treatment of IBD 5, 7.

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

5
Research

Dual Targeted Therapy for the Management of Inflammatory Bowel Disease.

Journal of clinical gastroenterology, 2021

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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