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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: 26 Mar 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

    • 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.
    • 23 Sep 2024 This trial has been completed in Sweden and Lithuania, according to European Clinical Trials Database record.
    • 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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