Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial.

ABSTRACT:

Importance

The phase 2 data presented here support the development of TSND-201 for posttraumatic stress disorder (PTSD), a disorder for which there is a significant unmet need for rapid-acting and effective treatments. TSND-201 (methylone) is a highly selective, rapid-acting neuroplastogen that releases serotonin, norepinephrine, and dopamine without direct activity at 5-hydroxytryptamine (5-HT) 2A receptors that has shown rapid, robust, and long-lasting benefit for preclinical PTSD-related behaviors and has been well tolerated in phase 1 studies of healthy volunteers.

Objective

To evaluate the efficacy and safety of TSND-201 vs placebo in adults with PTSD.

Design, setting, participants

A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1) part B

SUBMITTER: Jones A 

PROVIDER: S-EPMC12917749 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature