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AXS-05
AXS-05 is a combination of dextromethorphan and bupropion that enhances serotonergic and noradrenergic neurotransmission while modulating NMDA receptor activity.
AXS-05 is a combination of dextromethorphan and bupropion that enhances serotonergic and noradrenergic neurotransmission while modulating NMDA receptor activity. Used for Major depressive disorder.
At a glance
| Generic name | AXS-05 |
|---|---|
| Also known as | Bupropion/dextromethorphan |
| Sponsor | Axsome Therapeutics, Inc. |
| Drug class | Combination antidepressant (NMDA antagonist + norepinephrine-dopamine reuptake inhibitor) |
| Target | Sigma-1 receptor, NMDA receptor, norepinephrine transporter, dopamine transporter |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | FDA-approved |
Mechanism of action
The drug combines dextromethorphan (a sigma-1 receptor agonist and NMDA antagonist) with bupropion (a norepinephrine-dopamine reuptake inhibitor). This combination is designed to provide rapid-acting antidepressant effects through multiple mechanisms: bupropion increases norepinephrine and dopamine levels, while dextromethorphan acts on sigma-1 receptors and NMDA receptors to enhance neuroplasticity and reduce depressive symptoms more quickly than traditional antidepressants.
Approved indications
- Major depressive disorder (approved)
- Treatment-resistant depression (approved)
Common side effects
- Nausea
- Dizziness
- Headache
- Dry mouth
- Insomnia
- Sedation
Key clinical trials
- An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study (PHASE3)
- Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) (PHASE2)
- A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation (PHASE3)
- A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (PHASE3)
- A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms (PHASE4)
- Assessing Clinical Outcomes in Alzheimer's Disease Agitation (PHASE3)
- Addressing Dementia Via Agitation-Centered Evaluation (PHASE2, PHASE3)
- AXS-05 Phase II Trial on Smoking Behavior (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AXS-05 CI brief — competitive landscape report
- AXS-05 updates RSS · CI watch RSS
- Axsome Therapeutics, Inc. portfolio CI