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Brexanolone - Sage Therapeutics

Drug Profile

Brexanolone - Sage Therapeutics

Alternative Names: Allopregnanolone/sulfobutylether‐beta‐cyclodextrin; brexanolone IV; SAGE-547; SGE-102; ZULRESSO

Latest Information Update: 13 Aug 2020

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At a glance

  • Originator University of California, Davis
  • Developer SAGE Therapeutics
  • Class Antidepressants; Antiepileptic drugs; Small molecules; Steroids
  • Mechanism of Action GABA A receptor modulators
  • Orphan Drug Status

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

    Yes - Status epilepticus
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Postnatal depression
  • Discontinued Essential tremor; Major depressive disorder; Status epilepticus

Most Recent Events

  • 10 Aug 2020 The US FDA approves IND application for phase III trial under Coronavirus Treatment Acceleration Program for brexanolone in Adult respiratory distress syndrome
  • 10 Aug 2020 Sage Therapeutics plans a phase III trial for Respiratory distress syndrome in USA in second half of 2020
  • 02 Jul 2019 Launched for Postnatal depression in USA (IV)
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