{"id":"experimental-alz-801","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Amyloid-related imaging abnormalities (ARIA)"}]},"_chembl":null,"_fixedAt":"2026-03-30T16:13:43.332717","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ALZ-801 is designed to inhibit the formation and propagation of tau tangles, a hallmark pathology in Alzheimer's disease and other tauopathies. By targeting tau aggregation at the molecular level, the drug aims to slow cognitive decline in patients with early symptomatic Alzheimer's disease. It is an oral prodrug that converts to ALZ-101 in vivo.","oneSentence":"ALZ-801 is a small-molecule inhibitor of tau protein aggregation that crosses the blood-brain barrier to reduce pathological tau accumulation in the brain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:04.988Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)"}]},"_fixedFields":["pubmed(1)"],"trialDetails":[{"nctId":"NCT04770220","phase":"PHASE3","title":"An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects","status":"COMPLETED","sponsor":"Alzheon Inc.","startDate":"2021-05-19","conditions":"Early Alzheimer's Disease","enrollment":325},{"nctId":"NCT06304883","phase":"PHASE3","title":"Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alzheon Inc.","startDate":"2024-04-02","conditions":"Early Alzheimer's Disease","enrollment":163}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"recentPublications":[{"date":"2025 Feb 15","pmid":"39921439","title":"ALZ-801 prevents amyloid β-protein assembly and reduces cytotoxicity: A preclinical experimental study.","journal":"FASEB journal : official publication of the Federation of American Societies for Experimental Biology"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["valiltramiprosate","tramiprosate prodrug"],"phase":"phase_3","status":"active","brandName":"Experimental: ALZ-801","genericName":"Experimental: ALZ-801","companyName":"Alzheon Inc.","companyId":"alzheon-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ALZ-801 is a small-molecule inhibitor of tau protein aggregation that crosses the blood-brain barrier to reduce pathological tau accumulation in the brain. Used for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}