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A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio) in Participants With Relapsing Forms of Multiple Sclerosis

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Trial Profile

A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio) in Participants With Relapsing Forms of Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2026

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At a glance

  • Drugs Tolebrutinib (Primary) ; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI 1
  • Sponsors Genzyme Corporation - Medtronic (JV); Sanofi

Most Recent Events

  • 24 Apr 2026 According to a Sanofi media release, The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib) in the EU for the treatment of secondary progressive multiple sclerosis without relapses in the last two years, based on data from HERCULES, GEMINI 1 and GEMINI 2 trials.
  • 22 Sep 2025 According to a Sanofi media release, based on pivotal data from three global, double-blinded randomized studies: HERCULES and GEMINI 1 and 2, the US Food and Drug Administration (FDA) has extended by three months the target action date of its review of the new drug application (NDA) of tolebrutinib, in patients with nrSPMS and relapsing MS (RMS).
  • 22 Sep 2025 According to a Sanofi media release, based on the submission of additional analyses during the review, the FDA has determined that the additional information constituted a major amendment to the NDA and extended the target action date accordingly. The revised target action date for the FDA decision is December 28, 2025.

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