AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) announced that the US Patent and Trademark Office has granted a new patent covering EMP-01, its oral R-MDMA formulation.
The company said that the patent includes claims to the drug substance of EMP-01 and is expected to provide exclusivity through 2043.
It covers a highly crystalline, thermodynamically stable HCl salt form of R-MDMA with high aqueous solubility and low hygroscopicity, characteristics the company said are advantageous for formulation development, drug manufacturing, and storage.
AtaiBeckley is evaluating the drug for social anxiety disorder, a condition affecting about 18 million people in the US. The company is enrolling participants in a randomized, double-blind, placebo-controlled Phase 2 study, with topline results expected in the first quarter of 2026.
According to the company, the patent strengthens its intellectual property position for EMP-01 and supports its broader strategy to advance proprietary treatments for mental health conditions.
“EMP-01 is an important asset in our pipeline, and securing this patent issuance in the US further strengthens our ability to advance the program while delivering meaningful value for patients and shareholders,” AtaiBeckley CEO Dr Srinivas Rao said in a statement.
“We look forward to reporting topline data from the exploratory Phase 2a study evaluating EMP-01 in adults with social anxiety disorder in the first quarter of 2026.”
AtaiBeckley also noted that it continues to expand its global patent portfolio across its pipeline to support clinical development and potential commercialization.