Axsome’s AXS-05 challenges current standard of care for Alzheimer’s agitation

At the recent American Academy of Neurology (AAN) 2025 annual meeting, Axsome Therapeutics (Nasdaq: AXSM) presented promising data for AXS-05 (bupropion + dextromethorphan) in treating agitation associated with Alzheimer’s disease (AD).

With a novel, non-antipsychotic mechanism and a favorable safety profile, AXS-05 addresses a critical unmet need in managing distressing behavioral symptoms, potentially reshaping the current treatment paradigms in a space largely reliant on off-label antipsychotic use, says GlobalData, leading data and analytics company.

In August 2022, AXS-05 was approved in the USA for the treatment of depression under the trade name Auvelity and moving into Alzheimer’s agitation would be an important expansion. Chris Howerton, an analyst at Jefferies, previously predicted the drug could generate as much as $1.8 billion in peak yearly sales.