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Brexanolone - Lipocine

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Drug Profile

Brexanolone - Lipocine

Alternative Names: BRLIZIO; LPCN-1154; LPCN-1154A; LPCN-2201

Latest Information Update: 11 Aug 2026

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At a glance

  • Originator Lipocine
  • Class Antidepressants; Antiepileptic drugs; Ear disorder therapies; 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
  • Phase I Major depressive disorder

Most Recent Events

  • 04 Aug 2026 Lipocine schedules a guidance meeting with the FDA in the third quarter of 2026
  • 02 Apr 2026 Final efficacy data from a phase III trial in Postnatal depression released by Lipocine
  • 10 Mar 2026 Lipocine plans to file a 505(b) New Drug Application (NDA) for Postnatal depression in mid of 06. (946151)

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