Sanofi’s Phase 3 MS Study: Tolebrutinib vs. Teriflunomide

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

Sanofi’s recent clinical study, titled ‘A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis,’ aimed to evaluate the efficacy and safety of the BTK inhibitor Tolebrutinib (SAR442168) against Teriflunomide in treating relapsing forms of multiple sclerosis (MS). The primary objective was to assess the annualized relapse rate, while secondary objectives included evaluating disability progression, MRI lesions, cognitive performance, quality of life, and safety.

The study tested Tolebrutinib, an oral BTK inhibitor, designed to reduce MS relapses and progression by targeting specific pathways involved in the disease. Participants received either Tolebrutinib or Teriflunomide, with matching placebos to maintain blinding.

This Phase 3 trial was randomized and used a parallel intervention model with triple masking (participant, investigator, outcomes assessor) to ensure unbiased results. The primary purpose was treatment-focused, aiming to establish Tolebrutinib’s efficacy and safety compared to Teriflunomide.

The study began on June 30, 2020, and was completed with results first submitted on June 3, 2025, and the last update on June 30, 2025. These dates are crucial as they mark the study’s progression and the availability of data for analysis.

This update could influence Sanofi’s stock performance by potentially increasing investor confidence if the results show Tolebrutinib’s superiority or comparable efficacy to Teriflunomide. Competitors in the MS treatment market may also be impacted, depending on the study’s outcomes.

The study is completed, and further details are available on the ClinicalTrials portal.