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Atai Beckley NV, a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company’s intellectual property (IP) estate and long-term exclusivity for the program.
The newly granted US patent, No. 12,492,178, includes claims to the drug substance of EMP-01, and is expected to provide exclusivity through 2043. This patent identifies a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA with high aqueous solubility and low hygroscopicity, form-specific attributes that are beneficial during formulation development, drug product manufacture, as well as drug substance and drug product storage.
This patent protects critical drug substance attributes of EMP-01 and supports the company's strategy to develop innovative, differentiated therapies designed to address significant unmet needs in mental health.
“This patent grant reinforces the strength of our science and our long-term commitment to building durable, defensible innovation,” stated Srinivas Rao, chief executive officer and co-founder of AtaiBeckley. “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. 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 continues to expand its global patent portfolio across its pipeline to support clinical development, potential commercialization, and strategic flexibility as the company advances its mission to create new breakthroughs in mental health.
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 exploratory phase 2a study is anticipated in the first quarter of 2026.
AtaiBeckley was formed through the strategic combination of atai Life Sciences NV and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder, which are in phase 2 clinical development. It is also advancing a drug discovery programme to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
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