NEW YORK and BERLIN, May 13, 2025 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today announced that the first patient has been dosed in the exploratory Phase 2 study of EMP-01 (R-3,4-methylenedioxy-methamphetamine (R-MDMA)) for the treatment of social anxiety disorder (SAD).
“We are pleased to have dosed the first patient in the exploratory Phase 2 study evaluating EMP-01 in adults with social anxiety disorder,” stated Kevin Craig, M.D., Chief Medical Officer of atai. “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.”
The Phase 2 study is an exploratory, randomized, double-blind, placebo-controlled trial (NCT06693609) to assess the safety, tolerability and efficacy of EMP-01 in approximately 60 adults with SAD. Patients will be randomized 1:1 to receive two double-blind administrations of either EMP-01 or placebo, spaced four weeks apart. Symptoms will be monitored for six weeks following the first dose. The primary objective of the study is to assess the safety and tolerability of EMP-01 in adults with SAD. The secondary objective is to estimate any improvements in social anxiety symptoms compared to placebo.
About EMP-01 (Oral R-MDMA)
EMP-01 is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA) that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. Anxiety disorders are the most common mental health disorders worldwide, affecting how one experiences worry, fear and anxiety in everyday situations. Social anxiety disorder (SAD) is an area of high unmet medical need with approximately 18 million people currently diagnosed in the United States and no novel molecules approved in over two decades. atai is currently enrolling patients into an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD. Topline data from the Phase 2 study is anticipated in the first quarter of 2026.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn.