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FDA approves second-ever treatment for Alzheimer's agitation

As of May 2026: Leading commercial launch of second Auvelity indication

Until May 2023, no drug was approved in the United States to treat the agitation that affects up to three-quarters of people with Alzheimer's disease. Doctors reached for antipsychotics off-label, a class of medicines that carries a black-box warning for increased death risk in older dementia patients. On April 30, 2026, the FDA approved Axsome Therapeutics' Auvelity for the indication, doubling approved options from one to two. The FDA called it the 'first non-antipsychotic drug to treat agitation associated with dementia' — what sets it apart from Rexulti.

Updated May 31

Notable Quotes

'Auvelity offers a meaningful new option for patients, families, and clinicians managing one of the most distressing aspects of Alzheimer's disease.' — statement on approval

from FDA approves second-ever treatment for Alzheimer's agitation · Updated May 31

'We are very pleased to deliver to clinicians and patients a new, effective, FDA-approved treatment option, with a distinct mechanism of action, for this debilitating and critically underserved condition.' — post-approval statement, April 30, 2026

from FDA approves second-ever treatment for Alzheimer's agitation · Updated May 31