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Zuranolone - Biogen/SAGE Therapeutics

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Drug Profile

Zuranolone - Biogen/SAGE Therapeutics

Alternative Names: BIIB-125; S 812217; SAGE 217; SGE-797; ZURZUVAE

Latest Information Update: 30 Jul 2025

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At a glance

  • Originator SAGE Therapeutics
  • Developer Biogen; SAGE Therapeutics; Shionogi
  • Class Antidepressants; Antiepileptic drugs; Antiparkinsonians; Cyclopentanes; Mood stabilisers; Nitriles; Phenanthrenes; Pyrazoles; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA A receptor positive allosteric modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Seizures

Highest Development Phases

  • Marketed Postnatal depression
  • Preregistration Major depressive disorder
  • Phase III Insomnia
  • Phase II Anxiety disorders; Bipolar depression; Essential tremor; Parkinson's disease
  • Discontinued Dyskinesias; Seizures

Most Recent Events

  • 25 Jul 2025 Preregistration for Postnatal depression in European Union (PO), prior to July 2025
  • 25 Jul 2025 Biogen expects a final decision from the European Commission (EC) regarding approval of marketing authorization of Zuranolone for Postnatal depression in the third quarter of 2025
  • 25 Jul 2025 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues a positive opinion and recommends marketing authorization approval of Zuranolone for Postnatal depression

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