Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

The study, sponsored by Atai aims to explore the potential therapeutic effects of EMP-01, a novel R-enantiomer of MDMA, which has demonstrated enhanced serotonergic activity and fewer side effects compared to racemic MDMA. Previous research suggests that MDMA-like compounds can facilitate emotional processing, reduce social anxiety, and improve pro-social behaviours.

Participants will receive structured psychological support and be monitored for safety throughout the trial. The study is expected to begin in March 2025 and conclude in October 2025.

Topic Anxiety Safety
Compound MDMA Placebo
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

atai Life Sciences
atai Life Sciences is one of the biggest companies in the psychedelics field. The company aims to be a platform and has nine subsidiary companies working on everything from psilocybin for depression to DMT administration.

Data attribution

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