Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for the treatment of central nervous system (CNS) disorders. Established in 2012 and headquartered in New York City, the company pursues a strategy of leveraging proprietary formulations and mechanisms of action to address unmet medical needs. Axsome’s research and development efforts center on oral compounds designed to target conditions such as major depressive disorder, migraine, Alzheimer’s disease–related agitation, narcolepsy, and fibromyalgia.
Axsome’s lead marketed product, Auvelity (dextromethorphan and bupropion), received U.S. Food and Drug Administration approval for the treatment of major depressive disorder, representing the company’s first commercial offering. In addition to Auvelity, the company is advancing several pipeline candidates. AXS-07, a novel oral formulation combining rizatriptan and meloxicam for the acute treatment of migraine, has demonstrated positive clinical trial results. Other key programs include AXS-12 for narcolepsy and idiopathic hypersomnia, AXS-14 for fibromyalgia, and AXS-05 for Alzheimer’s disease agitation, each at various stages of clinical development.
Axsome serves patients and healthcare professionals primarily in the United States, while also pursuing regulatory approvals and commercialization partnerships in international markets. The company’s clinical programs are supported by data from randomized, controlled trials and an active publication record in peer-reviewed medical journals. Through collaborations with academic institutions and contract research organizations, Axsome seeks to accelerate the translation of its compounds from early-phase studies to regulatory review and market launch.
Leadership at Axsome Therapeutics is spearheaded by Chief Executive Officer Herriot Tabuteau, M.D., who co-founded the company and has more than a decade of experience in CNS drug development. Under his guidance, Axsome has expanded its pipeline and achieved key regulatory milestones. The executive team comprises seasoned professionals in clinical development, regulatory affairs, and commercial strategy, all committed to bringing innovative CNS therapies to patients with high unmet medical needs.
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