Drug Profile

Brexanolone - Lipocine

Alternative Names: LPCN-1154; LPCN-1154A

Latest Information Update: 02 Jul 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

26 Jun 2025 Lipocine plans to file a New Drug Application (NDA) for postnatal depression in the middle of 2026.
26 Jun 2025 Phase-III clinical trials in Postnatal depression in USA (In adolescents, In adults) (PO) (NCT06979544)
25 May 2025 Lipocine plans a phase III trial in Postnatal depression (In adolescent, In adults) in USA (PO, Tablets) in June 2025 (NCT06979544)

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