The European Medicines Agency (EMA) has recommended refusing to grant marketing authorization for Blarcamesine Anavex for the treatment of Alzheimer's disease in adults.The Agency's opinion was issued on December 11, 2025, and Anavex Germany GmbH may request a re-evaluation within 15 days.The main study included 462 adults aged 60 to 85 years with early Alzheimer's disease, where patients received either Blarcamesine Anavex or placebo for 48 weeks.[The main efficacy measures were reduction in cognitive decline and ability to perform activities of daily living.1 The agency stated that, based on the information provided, the formation of nitrosamine impurities that could potentially cause cancer could not be ruled out.1 The drug did not meet the criteria for conditional marketing authorization.1 The company stated that there were no implications for patients in clinical trials or compassionate use programs.1 The status of the application is currently under review.[1