Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.
Axsome’s pipeline includes several late-stage and approved product candidates. AXS-05, a first-in-class oral investigational therapy combining dextromethorphan and bupropion, received U.S. Food and Drug Administration (FDA) approval for the treatment of major depressive disorder in 2021 and for agitation associated with Alzheimer’s disease. AXS-07, a combination of meloxicam and rizatriptan for acute migraine, gained FDA approval in 2023. The company is also advancing AXS-12 for narcolepsy and idiopathic hypersomnia under FDA review, as well as AXS-14, a proprietary formulation of esreboxetine, targeting fibromyalgia and related chronic pain conditions.
Founded in 2012 and headquartered in New York City, Axsome Therapeutics conducts its research and development activities primarily in the United States. The company’s leadership team is led by President and Chief Executive Officer Herriot Tabuteau, M.D., who brings extensive experience in neurologic and psychiatric drug development. Under his guidance, Axsome has advanced multiple clinical programs through crucial regulatory milestones and continues to collaborate with academic institutions and contract research organizations to support its growth strategy.