Balinatunfib is named as an intervention in 3 current clinical trials in our USA, Italy, Czechia, India, China, Germany, France, Poland, Turkey, Canada, Brazil, Japan, Australia, Spain, Netherlands, South Korea, Belgium and Austria registers. None are recruiting at the moment. All registered phases are Phase 2. The lead sponsor is Sanofi. The most-studied condition is Crohn's Disease. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
NCT06637631 · Crohn's Disease
|
Phase 2 | Active, closed | Sanofi | USA, India, China, Germany, France, Spain, Italy, Netherlands, Poland, Czechia, Turkey, Canada, Brazil, Japan, South Korea, Australia |
|
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
NCT06867094 · Colitis Ulcerative
|
Phase 2 | Active, closed | Sanofi | USA, India, China, Germany, France, Italy, Belgium, Poland, Austria, Czechia, Turkey, Canada, Brazil, Japan, Australia |
|
A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)
NCT07222189 · ClinicalTrials.gov ↗ · Colitis Ulcerative, Crohn's Disease
|
Phase 2 | Active, closed | Sanofi | USA, Italy, Czechia |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Balinatunfib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis
2025-522511-42-00 · CTIS ↗ · Digestive System Diseases
|
Phase 2 | Ongoing | Sanofi-Aventis Recherche & Developpement | Belgium, Germany, Czechia + 11 more |
| Lead sponsor | Trials |
|---|---|
| Sanofi | 3 |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
3 current trials in our USA, Italy, Czechia, India, China, Germany, France, Poland, Turkey, Canada, Brazil, Japan, Australia, Spain, Netherlands, South Korea, Belgium and Austria registers name Balinatunfib (also registered as SAR441566) as a drug or biological intervention, as of the registry sync on 1 October 2026. Completed and withdrawn studies are not counted.
Not at the moment. None of the 3 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.
The lead sponsor is Sanofi. The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Balinatunfib works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Balinatunfib works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Balinatunfib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 1 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.