AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the treatment of central nervous system (CNS) conditions. AXS-05 consists of a proprietary formulation and dose of dextromethorphan (DM) and bupropion.

The safety and effectiveness of AXS-05 in Alzheimer’s disease agitation and smoking cessation have not been established and it is not approved by the FDA for these indications.

Mechanism of action of AXS-05

clinical and regulatory

AXS-05 is currently being developed for the treatment of major depressive disorder (MDD), Alzheimer’s disease agitation, and smoking cessation. We have received Breakthrough Therapy designation from the FDA for both major depressive disorder and Alzheimer’s disease agitation.