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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: 05 Nov 2025

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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

  • 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.
  • 25 Mar 2025 According to a Sanofi media release, the US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September 28, 2025. A regulatory submission is also under review in the EU.

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