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A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Trial Profile

A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2025

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At a glance

  • Drugs Brexanolone (Primary)
  • Indications Postnatal depression
  • Focus Registrational; Therapeutic Use
  • Sponsors Lipocine

Most Recent Events

  • 26 Jun 2025 According to a Lipocine media release, the Company will host a virtual research and development (R&D) investor event. The Company will provide a clinical, regulatory, and development update, including further details on the Phase 3 trial.
  • 26 Jun 2025 According to a Lipocine media release, the Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026
  • 26 Jun 2025 According to a Lipocine media release, first patients has been dosed.

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