New oral drug balinatunfib tested for long-term control of Crohn's and colitis

NCT ID NCT07222189

ENROLLING_BY_INVITATION Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety and effectiveness of balinatunfib, an oral tablet, in adults with Crohn's disease or ulcerative colitis. Participants have already completed a one-year treatment in a previous study. The trial will last up to 107 weeks and includes both double-blind and open-label periods. The main goal is to track side effects and see how well the drug controls the disease over time.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

balinatunfib (also known as SAR441566), an oral tablet

What this could lead to

If successful, this could show that balinatunfib is a safe long-term treatment option for managing Crohn's disease or ulcerative colitis.

What could go wrong

This is a Phase 2 extension study, so it's still early. The drug may not prove effective or safe over the long term, and side effects could emerge.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigational Site Number : 1000001

    Gorna Oryahovitsa, 5100, Bulgaria

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8331143, Chile