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Brexanolone - Lipocine

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Drug Profile

Brexanolone - Lipocine

Alternative Names: LPCN-1154; LPCN-1154A

Latest Information Update: 27 Nov 2025

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At a glance

  • Originator Lipocine
  • 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.

    No
  • New Molecular Entity No
  • Available For Licensing Yes - Postnatal depression

Highest Development Phases

  • Phase III Postnatal depression

Most Recent Events

  • 18 Nov 2025 Lipocine completes independent Data Safety Monitoring Board review of phase III trial of brexanolone in postnatal depression
  • 18 Nov 2025 Adverse events data from a phase III trial in Postnatal depression released by Lipocine
  • 06 Nov 2025 Lipocine plans a DSMB meeting to review the safety data from its phase III trial after the first one-third of participants have completed their Day-7 follow-up

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