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A phase 2 study of S-812217 in patients with major depressive disorder

Trial Profile

A phase 2 study of S-812217 in patients with major depressive disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Aug 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shionogi
  • Most Recent Events

    • 05 Aug 2023 According to a SAGE Therapeutics media release, the FDA issued a Complete Response Letter for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder and stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage and Biogen are reviewing the feedback and evaluating next steps.
    • 30 May 2023 Primary endpoint has been met (Change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score on Day 15) , according to Results published in the Psychiatry and Clinical Neurosciences
    • 30 May 2023 Results published in the Psychiatry and Clinical Neurosciences
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