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An open label, randomized, crossover pivotal PK clinical trial evaluating LPCN 1154 in healthy postmenopausal women

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Trial Profile

An open label, randomized, crossover pivotal PK clinical trial evaluating LPCN 1154 in healthy postmenopausal women

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Brexanolone (Primary) ; Brexanolone
  • Indications Postnatal depression
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Lipocine

Most Recent Events

  • 13 Mar 2025 According to a Lipocine media release, the company held a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 to discuss the NDA submission package for LPCN 1154. In the meeting, Lipocine was advised in addition to the previously completed PK bridge data, a safety and efficacy study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.
  • 25 Jun 2024 Results published in a Lipocine media release
  • 25 Jun 2024 According to a Lipocine media release, post-menopausal women (safety set), and completed dosing in both study periods.

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