{"id":"clemizole-hcl","safety":{"commonSideEffects":[{"rate":null,"effect":"Drowsiness / sedation"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Clemizole is a first-generation antihistamine that crosses the blood-brain barrier and antagonizes H1 receptors on mast cells, basophils, and other immune cells. By blocking histamine signaling, it reduces allergic and inflammatory responses. The drug has also been investigated for potential immunomodulatory effects beyond classical antihistamine activity.","oneSentence":"Clemizole HCl is a histamine H1-receptor antagonist that blocks histamine-mediated immune and inflammatory responses.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:06:18.075Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic conditions and pruritus (investigational in Phase 3)"}]},"trialDetails":[{"nctId":"NCT05066217","phase":"PHASE3","title":"An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome","status":"RECRUITING","sponsor":"Epygenix","startDate":"2025-04-09","conditions":"Lennox Gastaut Syndrome","enrollment":260},{"nctId":"NCT04462770","phase":"PHASE3","title":"A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome","status":"RECRUITING","sponsor":"Epygenix","startDate":"2020-09-15","conditions":"Dravet Syndrome","enrollment":150},{"nctId":"NCT04069689","phase":"PHASE1","title":"Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.","status":"COMPLETED","sponsor":"Epygenix","startDate":"2019-08-29","conditions":"Dravet Syndrome","enrollment":24},{"nctId":"NCT00945880","phase":"PHASE1","title":"Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive","status":"COMPLETED","sponsor":"Eiger BioPharmaceuticals","startDate":"2009-07","conditions":"Hepatitis C","enrollment":12},{"nctId":"NCT03069508","phase":"PHASE2","title":"Clemizole HCl for Subjects With Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Eiger Group International, Inc.","startDate":"2017-02-13","conditions":"Hepatocellular Carcinoma","enrollment":12}],"_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":["EPX-100","Clemizole"],"phase":"phase_3","status":"active","brandName":"Clemizole HCl","genericName":"Clemizole HCl","companyName":"Epygenix","companyId":"epygenix","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Clemizole HCl is a small molecule used in clinical trials for various conditions, including Dravet Syndrome, Hepatocellular Carcinoma, Lennox Gastaut Syndrome, and Hepatitis C. It has been studied in a 20-week multicenter trial as EPX-100 (Clemizole Hydrochloride) in participants with Dravet Syndrome.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}