Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi has recently completed a Phase 3 clinical study titled ‘Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES).’ The study aimed to evaluate the efficacy and safety of SAR442168, a BTK inhibitor, in delaying disability progression in patients with NRSPMS. This study is significant as it explores a potential treatment option for a challenging stage of multiple sclerosis.
The intervention tested in this study was Tolebrutinib, administered as a 60 mg oral tablet daily. Tolebrutinib is designed to inhibit Bruton’s Tyrosine Kinase, which is involved in the progression of multiple sclerosis, thereby potentially slowing the disease’s advancement.
The study was designed as a randomized, double-blind, placebo-controlled trial with a parallel intervention model. Participants, investigators, and outcomes assessors were masked to the treatment allocations. The primary purpose was treatment-focused, aiming to assess the impact of Tolebrutinib on disability progression.
The study commenced on September 24, 2020, and was completed with the primary results submitted on June 3, 2025. The latest update was provided on July 1, 2025. These dates are crucial as they mark the progression and conclusion of the trial, providing a timeline for investors to assess the study’s impact.
The completion of this study could positively influence Sanofi’s stock performance and investor sentiment, as successful results may position Tolebrutinib as a leading treatment for NRSPMS. This development could also impact the competitive landscape, with Sanofi potentially gaining an edge over competitors in the multiple sclerosis treatment market.
The study is now completed, and further details are available on the ClinicalTrials portal.