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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

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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

  • 05 Aug 2025 According to a Lipocine media release, This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD, with topline results expected in the second quarter of 2026 and a 505(b)(2) New Drug Application (NDA) submission in the U.S. expected in mid-2026.
  • 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

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