Otsuka & Lundbeck

New Capabilities

As of May 2026: Maker of incumbent treatment Rexulti

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