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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

COLITIS, ULCERATIVE CROHN'S DISEASE

Contacts and locations

Locations

Investigational Site Number : 1000001

Gorna Oryahovitsa, 5100, Bulgaria
Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago, 8331143, Chile

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