{"id":"avp-786-42-63","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neuroinflammation and neurodegeneration.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:18.242Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Agitation associated with Alzheimer's disease dementia"},{"name":"Dementia with Lewy bodies"}]},"trialDetails":[{"nctId":"NCT03095066","phase":"PHASE2","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2017-05-30","conditions":"Neurobehavioral Disinhibition","enrollment":168},{"nctId":"NCT02446132","phase":"PHASE3","title":"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","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2015-11-13","conditions":"Agitation in Patients With Dementia of the Alzheimer's Type","enrollment":1197},{"nctId":"NCT04464564","phase":"PHASE3","title":"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","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2020-09-11","conditions":"Agitation in Patients With Dementia of the Alzheimer's Type","enrollment":241},{"nctId":"NCT04408755","phase":"PHASE3","title":"Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2020-07-13","conditions":"Agitation in Patients With Dementia of the Alzheimer's Type","enrollment":184},{"nctId":"NCT02442778","phase":"PHASE3","title":"Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2015-11-11","conditions":"Agitation in Participants With Dementia of the Alzheimer's Type","enrollment":522},{"nctId":"NCT03420222","phase":"PHASE2","title":"Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2018-01-18","conditions":"Intermittent Explosive Disorder","enrollment":10}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"AVP-786-42.63","genericName":"AVP-786-42.63","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}