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Brexanolone - Sage Therapeutics

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Drug Profile

Brexanolone - Sage Therapeutics

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

Latest Information Update: 05 Nov 2024

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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
  • Phase II Tinnitus
  • Discontinued Essential tremor; Major depressive disorder; SARS-CoV-2 acute respiratory disease; Status epilepticus

Most Recent Events

  • 29 Oct 2024 Sage announced the plans to discontinue brexanolone (ZULRESSO) as a part of its strategic shift to further focus on the commercialization of Zuranolone (ZURZUVAE) as of December 2024
  • 21 Nov 2023 Sage Therapeutics completes a phase II trial in Tinnitus in USA (IV) (NCT05645432)
  • 10 May 2023 Phase-II clinical trials in Tinnitus in USA (IV) (NCT05645432)

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