{"id":"extended-release-galantamine-hydrobromide","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Nausea"},{"rate":"5-10","effect":"Vomiting"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Dizziness"},{"rate":"5-10","effect":"Headache"},{"rate":"1-3","effect":"Syncope"},{"rate":"1-3","effect":"Bradycardia"}]},"_chembl":{"chemblId":"CHEMBL1555","moleculeType":"Small molecule","molecularWeight":"368.27"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting acetylcholinesterase, galantamine increases the concentration of acetylcholine at synapses, enhancing cholinergic neurotransmission. Additionally, galantamine allosterically modulates nicotinic acetylcholine receptors, potentiating their response to acetylcholine. This dual mechanism is intended to improve cognitive function and slow cognitive decline in neurodegenerative conditions.","oneSentence":"Galantamine is a cholinesterase inhibitor that increases acetylcholine levels in the brain by blocking its breakdown, and also acts as an allosteric modulator of nicotinic receptors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:12:03.080Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mild to moderate Alzheimer's disease"}]},"trialDetails":[{"nctId":"NCT07284290","phase":"PHASE4","title":"Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia","status":"RECRUITING","sponsor":"Virginia Commonwealth University","startDate":"2025-12-08","conditions":"Dementia With Lewy Bodies, Parkinson Disease Dementia, Healthy Controls","enrollment":120},{"nctId":"NCT03384784","phase":"PHASE2","title":"Effect of Galantamine on Inflammation and Cognition","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2017-10-30","conditions":"HIV Associated Cognitive Motor Complex","enrollment":63},{"nctId":"NCT01880099","phase":"NA","title":"A Study to Help People Quit Smoking.","status":"COMPLETED","sponsor":"Yale University","startDate":"2013-12","conditions":"Nicotine Dependence","enrollment":60},{"nctId":"NCT01669538","phase":"PHASE2","title":"Effect of Galantamine on Short-term Abstinence","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2012-08","conditions":"Tobacco Use Disorder","enrollment":98},{"nctId":"NCT00809835","phase":"PHASE2","title":"Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse","status":"COMPLETED","sponsor":"Yale University","startDate":"2007-12","conditions":"Cocaine Dependence","enrollment":120},{"nctId":"NCT01548638","phase":"PHASE2","title":"Effect of Galantamine on Smoking Abstinence","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2012-02","conditions":"Nicotine Addiction","enrollment":13},{"nctId":"NCT00741598","phase":"PHASE4","title":"Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2008-09","conditions":"Bipolar Disorder","enrollment":72},{"nctId":"NCT00077727","phase":"PHASE3","title":"A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2003-03","conditions":"Schizophrenia","enrollment":107},{"nctId":"NCT00082602","phase":"PHASE3","title":"Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-05","conditions":"Alzheimer's Disease","enrollment":83},{"nctId":"NCT01039194","phase":"PHASE1","title":"Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2010-01","conditions":"Alzheimer Disease","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"Extended-release galantamine hydrobromide","genericName":"Extended-release galantamine hydrobromide","companyName":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","companyId":"johnson-johnson-pharmaceutical-research-development-l-l-c","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Galantamine is a cholinesterase inhibitor that increases acetylcholine levels in the brain by blocking its breakdown, and also acts as an allosteric modulator of nicotinic receptors. Used for Mild to moderate Alzheimer's disease.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}