{"id":"avp-786-18","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL3642611","moleculeType":"Small molecule","molecularWeight":"394.29"},"_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. This combination allows for lower doses while maintaining therapeutic efficacy. The sigma-1 receptor modulation is thought to provide neuroprotective and neuromodulatory effects relevant to neurodegenerative and neuropsychiatric conditions.","oneSentence":"AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neurological symptoms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:03.738Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Agitation associated with Alzheimer's disease dementia"},{"name":"Potential indication in other neurodegenerative or neuropsychiatric conditions"}]},"trialDetails":[{"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":"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}],"_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-786-18","genericName":"AVP-786-18","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 neurological symptoms. Used for Agitation associated with Alzheimer's disease dementia, Potential indication in other neurodegenerative or neuropsychiatric conditions.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}