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AVP-786-42.63
AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neuroinflammation and neurodegeneration.
AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neuroinflammation and neurodegeneration. Used for Agitation associated with Alzheimer's disease dementia, Dementia with Lewy bodies.
At a glance
| Generic name | AVP-786-42.63 |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Sigma-1 receptor agonist |
| Target | Sigma-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
The deuterated dextromethorphan component acts as a sigma-1 receptor agonist, which modulates neuroinflammatory pathways and protects against neuronal damage. Quinidine is included as a cytochrome P450 2D6 inhibitor to increase the bioavailability and half-life of dextromethorphan, allowing for lower doses and improved tolerability. This combination is designed to address neurodegenerative and neuropsychiatric conditions by reducing neuroinflammation.
Approved indications
- Agitation associated with Alzheimer's disease dementia
- Dementia with Lewy bodies
Common side effects
- Dizziness
- Headache
- Fatigue
- Nausea
Key clinical trials
- Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury (PHASE2)
- Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type (PHASE3)
- Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder (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:
- AVP-786-42.63 CI brief — competitive landscape report
- AVP-786-42.63 updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI