Sanofi’s New Study on Rilzabrutinib: A Potential Breakthrough for ITP Treatment

Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.

Sanofi has announced a new clinical study titled ‘A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment.’ The study aims to assess the effectiveness and safety of rilzabrutinib, a drug intended to modulate the immune system in patients with ITP who have not responded to initial treatments. This research is significant as it could offer a new therapeutic option for a challenging condition.

The intervention being tested is rilzabrutinib, administered orally in tablet form at a dosage of 400 mg twice daily. It is designed to provide early multi-immune modulation for patients with ITP.

This Phase 3 study is interventional, with a single-group assignment and no masking, focusing primarily on treatment. Participants will undergo a screening period, a primary analysis period, a long-term extension for some, and a follow-up period for eligible individuals.

The study is set to start on September 15, 2025, with primary completion and estimated completion dates yet to be determined. The last update was submitted on August 14, 2025. These dates are crucial for tracking the study’s progress and potential market entry.

The initiation of this study could positively influence Sanofi’s stock performance by signaling potential advancements in ITP treatment, which may enhance investor confidence. As the pharmaceutical industry is highly competitive, this development could position Sanofi favorably against its peers.

The study is ongoing, with further details available on the ClinicalTrials portal.