FDA Grants Priority Review to AXS-05 for Agitation in Alzheimer Disease, Sets April 2026 PDUFA Date

The US Food and Drug Administration has accepted for filing a supplemental new drug application for AXS-05 for the treatment of agitation associated with Alzheimer disease and has granted the application Priority Review, according to an announcement from Axsome Therapeutics. The agency set a Prescription Drug User Fee Act target action date of April 30, 2026.

Priority Review is granted to applications for therapies that, if approved, could provide significant improvements in the treatment of serious conditions compared with available options. Under Priority Review, the FDA aims to take regulatory action within 6 months rather than the standard 10-month review period.

“We are very pleased the FDA has accepted and granted priority review to our supplemental NDA for AXS-05 for the treatment of Alzheimer’s disease agitation,” Herriot Tabuteau, MD, chief executive officer of Axsome Therapeutics, said in the company’s release. “Up to 76% of people with Alzheimer’s disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments. We look forward to continuing to work with the FDA for the remainder of the review.”

The FDA previously granted Breakthrough Therapy designation to AXS-05 for Alzheimer disease agitation in June 2020. That designation is intended to expedite development and review timelines for investigational therapies when preliminary clinical evidence suggests substantial improvement over existing treatments for serious or life-threatening conditions.

The supplemental application is supported by a clinical development program that included four randomized, double-blind, controlled phase 3 trials and a long-term safety study in patients with Alzheimer disease agitation, according to the company.

Alzheimer disease is the most common cause of dementia, affecting an estimated 7 million people in the US. Agitation is reported in up to 76% of patients and is characterized by emotional distress, verbal or physical aggressiveness, disruptive irritability, and disinhibition. Prior research has linked agitation in Alzheimer disease to accelerated cognitive decline, increased caregiver burden, earlier nursing home placement, and higher mortality.

AXS-05 is an oral investigational therapy that combines dextromethorphan and bupropion and is designed to modulate multiple central nervous system pathways. The product is approved in the US for the treatment of major depressive disorder in adults but has not been approved for the treatment of Alzheimer disease agitation.

If approved for this indication, AXS-05 would represent an additional pharmacologic option for managing agitation in patients with Alzheimer disease, a symptom that remains challenging to treat in routine clinical practice.

Reference: Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation. News release. Axsome Therapeutics. December 31, 2025. Accessed January 2, 2026. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-acceptance-and-priority-0