Brexanolone

Drug Profile

Brexanolone

Alternative Names: SAGE-547; SGE-102

Latest Information Update: 27 Sep 2017

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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

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

Most Recent Events

  • 12 Sep 2017 Top-line efficacy and adverse events data from a phase III trial in Status epilepticus released by Sage Therapeutics
  • 11 Aug 2017 SAGE completes the phase III STATUS trial for Status epilepticus (Adjunctive treatment, In children, In adolescents, In adults) in USA, Estonia, Italy, Spain Netherlands, Finland, France, Canada, Israel, Serbia, Germany, Belgium, Sweden, Denmark, Hungary and Austria (IV) (NCT02477618)
  • 03 Aug 2017 Sage Therapeutics announces intention to submit MAA to EMA for Postnatal depression in the EU
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