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
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, Puerto Rico, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Trial Start Expected - Axsome announced they will initiate a P2 Smoking Cessation trial in 4Q25 for AXS-05
- Clinical Outcomes Reported - Axsome presented P3 Alzheimer Disease results on 2025-05-29 for AXS-05
- Clinical Outcomes Reported - Axsome presented P3 Alzheimer Disease results on 2025-04-07 for AXS-05
Highest Development Phases
Phase 3: Alzheimer Disease|Psychomotor Agitation
Phase 2: Smoking Cessation|Tobacco Use Disorder
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03450941 |
Pro00089413 | P2 |
Not yet recruiting |
Smoking Cessation|Tobacco Use Disorder |
2018-12-31 |
2019-03-22 |
Treatments |
|
NCT04947553 |
ACCORD-2 | P3 |
Completed |
Psychomotor Agitation|Alzheimer Disease |
2024-12-03 |
15% |
2025-01-18 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05557409 |
ADVANCE-2 | P3 |
Completed |
Alzheimer Disease|Psychomotor Agitation |
2024-11-21 |
38% |
2025-11-27 |
Primary Endpoints|Treatments |