{"id":"avp-786-28","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug combines dextromethorphan (a sigma-1 receptor agonist) with quinidine, which inhibits the metabolism of dextromethorphan and increases its bioavailability. Sigma-1 receptor activation is thought to modulate neuroprotective pathways and reduce neuroinflammation. The deuteration of dextromethorphan improves its pharmacokinetic profile and duration of action.","oneSentence":"AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce agitation and behavioral symptoms in neurodegenerative diseases.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:18.259Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Agitation associated with Alzheimer's disease dementia"},{"name":"Agitation in other neurodegenerative diseases"}]},"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":"NCT02442765","phase":"PHASE3","title":"Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2015-07-23","conditions":"Agitation in Patients With Dementia of the Alzheimer's Type","enrollment":387},{"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-786-28","genericName":"AVP-786-28","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AVP-786-28 is an intervention in a clinical trial studying the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in participants with dementia of the Alzheimer's type. The conditions studied in this trial include agitation in participants with dementia of the Alzheimer's type, among others such as neurobehavioral disinhibition and intermittent explosive disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}