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A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 May 2026

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At a glance

  • Drugs Luvesilocin (Primary)
  • Indications Postnatal depression
  • Focus Therapeutic Use
  • Acronyms RECONNECT
  • Sponsors Reunion Neuroscience

Most Recent Events

  • 11 May 2026 According to Reunion Neuroscience, Inc. media release, based on data from this trial the company aligned with the U.S. Food and Drug Administration (FDA) on a registrational path for luvesilocin in postpartum depression. Based on feedback from the FDA, Reunion expects that the results from this single Phase 3 trial, if successful, would complete the data package required to support potential registration of luvesilocin in PPD.
  • 11 May 2026 According to Reunion Neuroscience, Inc. media release, data from this trial will be shared at at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2026-Psychiatry and AI: Promises, Perils, and Pathways Forward in Miami, FL.
  • 23 Feb 2026 According to Reunion Neuroscience, Inc. media release, the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to luvesilocin (formerly RE104) for the treatment of postpartum depression (PPD). BTD for luvesilocin is supported by strong positive efficacy data from the RECONNECT Phase 2 clinical trial.

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