Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 09 Apr 2026

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At a glance

Drugs Methylone (Primary)
Indications Post-traumatic stress disorders
Focus Registrational; Therapeutic Use
Acronyms EMPOWER-1
Sponsors Transcend Therapeutics

Most Recent Events

27 Mar 2026 According to Otsuka Pharmaceutical media release, Transcend met with the FDA in September 2025, to discuss company plans to expedite the development of TSND-201 and confirm the design of the Phase 3 study. Patient recruitment for the Phase 3 trial is underway in the U.S.
13 Mar 2026 New trial record

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