Brexanolone - Sage Therapeutics

Drug Profile

Brexanolone - Sage Therapeutics

Alternative Names: SAGE-547; SGE-102; ZULRESSO

Latest Information Update: 13 Aug 2018

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At a glance

  • Originator Sage Therapeutics
  • 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

  • Preregistration Postnatal depression
  • Phase III Status epilepticus
  • Phase II Essential tremor
  • Preclinical Major depressive disorder

Most Recent Events

  • 07 Aug 2018 SAGE Therapeutics anticipates scientific advice from EMA for development in Postnatal depression in the fourth quarter of 2018
  • 07 Aug 2018 The US FDA plans to hold an advisory committee meeting to discuss the applications of brexanolone in Postnatal depression
  • 07 Aug 2018 The US FDA conditionally accepts the proprietary name ZULRESSO™ for brexanolone
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