Trial Profile

A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

Status: Completed

Phase of Trial: Phase I/II

Latest Information Update: 22 Jul 2025

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At a glance

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

Most Recent Events

10 Jul 2025 According to a Transcend Therapeutics media release,based on the positive results from this trial the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to TSND-201 (methylone) for the treatment of Post-Traumatic Stress Disorder (PTSD).
31 Mar 2025 Primary endpoint has been met. (Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score)
31 Mar 2025 Results presented in a Transcend Therapeutics media release.

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