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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: 30 Jun 2025

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At a glance

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

Most Recent Events

  • 23 Jun 2025 According to a Lipocine media release, the data readout is expected in Q2-2026.
  • 18 Jun 2025 Status changed from not yet recruiting to recruiting.
  • 08 May 2025 According to a Lipocine media release, the Phase 3 study is expected to support a New Drug Application (NDA) submission in 2026.

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