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A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder

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Trial Profile

A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Nov 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Sponsors Biogen

    • Most Recent Events

    • 16 Feb 2023 According to a SAGE Therapeutics media release, additional analysis of data from this study will be present in 2023.
    • 06 Feb 2023 According to a SAGE Therapeutics media release, The NDA includes data from the LANDSCAPE and NEST clinical development programs as well as a Phase 2 study of zuranolone completed by Shionogi in Japan in adults with MDD. The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). The NEST program includes two studies of zuranolone in adult women with PPD (ROBIN and SKYLARK).
    • 06 Feb 2023 According to a SAGE Therapeutics media release, the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.

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