AtaiBeckley N.V. has been granted a new United States patent covering its investigational mental health therapy EMP-01, strengthening the company’s intellectual property portfolio and extending potential programme exclusivity through 2043. The patent was issued by the U.S. Patent and Trademark Office on December 11, 2025.
Patent No. 12,492,178 includes claims on the drug substance of EMP-01, an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA). It protects a highly crystalline, thermodynamically stable hydrochloride salt form with high aqueous solubility and low hygroscopicity, characteristics that support formulation development, manufacturing, and long-term storage.
EMP-01 is being developed for social anxiety disorder, a condition affecting an estimated 18 million people in the United States, with no novel therapies approved in more than two decades. In a Phase 1 study, the therapy demonstrated a dose-dependent subjective effect profile that was generally more similar to classical psychedelics than racemic MDMA.
The company is currently enrolling patients in a randomised, double-blind, placebo-controlled Phase 2a trial assessing the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder, with topline data expected in the first quarter of 2026.
Formed in November 2025 through the merger of atai Life Sciences N.V. and Beckley Psytech Limited, AtaiBeckley is advancing a pipeline that includes BPL-003 and VLS-01 for treatment-resistant depression, alongside EMP-01, and a drug discovery programme targeting non-hallucinogenic 5-HT2A receptor agonists for opioid use disorder and treatment-resistant depression.
Also Read