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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: 25 Jun 2025

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At a glance

  • Drugs Tolebrutinib (Primary) ; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI 2
  • Sponsors Sanofi; Sanofi Genzyme

Most Recent Events

  • 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.
  • 20 Sep 2024 Results published in a Sanofi media release
  • 20 Sep 2024 According to a Sanofi media release, results from this study will form the basis for future discussions with global regulatory authorities with submissions starting in H2 2024.

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