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A Phase III trial of IV ganaxolone for the treatment of Postpartum Depression

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Trial Profile

A Phase III trial of IV ganaxolone for the treatment of Postpartum Depression

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2025

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At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Postnatal depression
  • Focus Therapeutic Use
  • Sponsors Marinus Pharmaceuticals

Most Recent Events

  • 26 Sep 2019 According to a Marinus Pharmaceuticals media release, the Company is evaluating a new ready-to-use dose formulation that does not require compounding, mixing or diluting. This will enable immediate administration at the bedside and ensure patients receive the benefits of treatment as rapidly as possible. This new formulation will be evaluated in a few additional patients with data to be included in the End-of-Phase 2 meeting which is anticipated in Q1 2020.
  • 28 Aug 2019 New trial record
  • 08 Aug 2019 According to a Marinus Pharmaceuticals media release, the company is planning to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 program for IV ganaxolone in PPD.

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