{"id":"cerezyme-imiglucerase","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Antibody formation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gaucher disease is a lysosomal storage disorder caused by deficiency of the enzyme glucocerebrosidase (also called β-glucosidase), leading to accumulation of glucocerebroside in macrophages and other cells. Imiglucerase is a recombinant human glucocerebrosidase produced in mammalian cell culture that replaces the deficient enzyme, allowing degradation of accumulated substrate and reduction of pathological lipid burden in affected tissues.","oneSentence":"Imiglucerase is a recombinant glucocerebrosidase enzyme that breaks down glucocerebroside, a lipid that accumulates in Gaucher disease.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:31:47.655Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Gaucher disease type 1"},{"name":"Gaucher disease type 3"}]},"trialDetails":[{"nctId":"NCT04370665","phase":"NA","title":"Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease","status":"COMPLETED","sponsor":"InSightec","startDate":"2020-07-16","conditions":"Parkinson Disease","enrollment":4},{"nctId":"NCT05222906","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2022-04-18","conditions":"Gaucher's Disease Type III","enrollment":43},{"nctId":"NCT04656600","phase":"PHASE4","title":"Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-03-02","conditions":"Gaucher's Disease","enrollment":12},{"nctId":"NCT03519646","phase":"NA","title":"Eliglustat on Gaucher Disease Type IIIB","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2018-04-23","conditions":"Gaucher Disease, Type III","enrollment":4},{"nctId":"NCT02574286","phase":"PHASE4","title":"Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease","status":"COMPLETED","sponsor":"Shire","startDate":"2016-06-29","conditions":"Gaucher Disease","enrollment":21},{"nctId":"NCT00430625","phase":"PHASE3","title":"A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher Disease","status":"COMPLETED","sponsor":"Shire","startDate":"2007-02-15","conditions":"Gaucher Disease, Type 1","enrollment":25},{"nctId":"NCT00391625","phase":"PHASE1, PHASE2","title":"Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT)","status":"COMPLETED","sponsor":"Shire","startDate":"2004-09-13","conditions":"Gaucher Disease","enrollment":10},{"nctId":"NCT00635427","phase":"PHASE3","title":"An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease","status":"COMPLETED","sponsor":"Shire","startDate":"2008-03-13","conditions":"Gaucher Disease, Type 1","enrollment":95},{"nctId":"NCT00478647","phase":"PHASE2, PHASE3","title":"Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With Imiglucerase","status":"COMPLETED","sponsor":"Shire","startDate":"2007-07-25","conditions":"Gaucher Disease","enrollment":40},{"nctId":"NCT00553631","phase":"PHASE3","title":"Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease","status":"COMPLETED","sponsor":"Shire","startDate":"2008-01-29","conditions":"Gaucher Disease, Type 1","enrollment":34},{"nctId":"NCT04787887","phase":"PHASE1","title":"A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers","status":"COMPLETED","sponsor":"ISU Abxis Co., Ltd.","startDate":"2020-01-29","conditions":"Gaucher Disease","enrollment":42},{"nctId":"NCT00943111","phase":"PHASE3","title":"A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2009-09","conditions":"Gaucher Disease, Type 1","enrollment":160},{"nctId":"NCT01161914","phase":"PHASE3","title":"The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease","status":"WITHDRAWN","sponsor":"ISU Abxis Co., Ltd.","startDate":"2011-01","conditions":"Gaucher Disease","enrollment":""},{"nctId":"NCT00364858","phase":"PHASE4","title":"Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2001-12","conditions":"Gaucher Disease, Type 1, Cerebroside Lipidosis Syndrome, Glucocerebrosidase Deficiency Disease","enrollment":95}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":292,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Cerezyme® / Imiglucerase","genericName":"Cerezyme® / Imiglucerase","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cerezyme (Imiglucerase) is a medication used to treat Gaucher Disease, Type 1, and other related conditions such as Glucocerebrosidase Deficiency Disease and Glucosylceramide Beta-Glucosidase Deficiency Disease. It works by replacing the deficient enzyme glucocerebrosidase in patients with these conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}