Product Description
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. (Sourced from: https://www.axsome.com/axs-pipeline/about-axs-05)
Mechanisms of Action: NDR Inhibitor,S1R Inhibitor,NMA Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Alzheimer Disease *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Axsome
Company Location: NEW YORK NY 10007
Company CEO: Herriot Tabuteau
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Alzheimer Disease|Psychomotor Agitation
Phase 2: Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant|Smoking Cessation|Tobacco Use Disorder
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
ADVANCE-2 | P3 |
Recruiting |
Psychomotor Agitation|Alzheimer Disease |
2025-06-01 |
31% |
AXS-05-AD-303 | P3 |
Enrolling by invitation |
Psychomotor Agitation|Alzheimer Disease |
2024-12-01 |
31% |
ACCORD | P3 |
Completed |
Psychomotor Agitation|Alzheimer Disease |
2022-11-21 |
31% |
EVOLVE | P2 |
Completed |
Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant |
2022-03-04 |
32% |