atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that it has dosed the first patient in its Phase 2 clinical trial of EMP-01 for the treatment of social anxiety disorder (SAD).
EMP-01, an oral formulation of R-3,4-methylenedioxy-methamphetamine, is being investigated in an exploratory, randomized, double-blind, placebo-controlled study involving approximately 60 adult participants with SAD.
The primary goal of the trial is to assess the safety and tolerability of EMP-01, while a secondary objective is to explore improvements in social anxiety symptoms compared to placebo, with topline results expected in the first quarter of 2026.
Participants in the trial will be randomly assigned to receive two administrations of either EMP-01 or a placebo, spaced four weeks apart. Their symptoms will be monitored for six weeks following the initial dose.
"We are pleased to have dosed the first patient in the exploratory Phase 2 study evaluating EMP-01 in adults with social anxiety disorder," atai chief medical officer Dr Kevin Craig said in a statement.
"Social anxiety disorder affects millions and remains significantly underserved by current treatment options. We believe this Phase 2 study will provide critical insights into EMP-01’s potential to address this large and growing market with substantial unmet need.”
In a previous Phase 1 study, EMP-01 demonstrated a dose-dependent subjective effect profile described as more similar to classical psychedelics than to racemic MDMA.
According to atai, this profile supports its potential as a novel treatment option for social anxiety disorder, a condition that remains challenging to treat effectively with existing therapies.