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 assess the efficacy and safety of SAR442168 compared to a placebo in delaying disability progression in patients with NRSPMS. This research is significant as it explores potential treatments for a challenging stage of multiple sclerosis where options are limited.
The intervention tested was Tolebrutinib, a BTK inhibitor administered as a 60 mg oral tablet once daily. Its purpose is to delay the progression of disability in NRSPMS patients.
The study was designed as a randomized, double-blind, placebo-controlled trial with a parallel intervention model. Triple masking was used, involving participants, investigators, and outcomes assessors, with the primary purpose being treatment.
The study began on September 24, 2020, and was completed with results first submitted on June 3, 2025. The last update was submitted on July 1, 2025. These dates are crucial as they mark the progression and completion of the study, providing a timeline for data analysis and publication.
The completion of this study could positively impact Sanofi’s stock performance and investor sentiment, as successful results may lead to a new treatment option for NRSPMS, potentially increasing market share. Competitors in the multiple sclerosis treatment space will be closely monitoring these developments.
The study is now completed, with further details available on the ClinicalTrials portal.