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 dextromethorphan component of AXS-05 is an antagonist of the NMDA receptor, an ionotropic glutamate receptor, and a sigma-1 receptor agonist
- These actions modulate glutamatergic neurotransmission
- The bupropion component of AXS-05 serves primarily to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor
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.
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.