{"id":"agalsidase-beta-gz419828","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fabry disease is caused by deficiency of the enzyme alpha-galactosidase A, leading to accumulation of the glycosphingolipid Gb3 in various tissues. Agalsidase beta is a recombinant replacement enzyme that catalyzes the hydrolysis of Gb3, reducing pathological substrate accumulation in endothelial cells, cardiomyocytes, and renal cells. This enzyme replacement therapy helps prevent or slow progressive organ damage characteristic of Fabry disease.","oneSentence":"Agalsidase beta is a recombinant human alpha-galactosidase A enzyme that breaks down globotriaosylceramide (Gb3) accumulation in cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:20:29.591Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fabry disease"}]},"trialDetails":[{"nctId":"NCT05280548","phase":"PHASE3","title":"A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2022-05-03","conditions":"Fabry Disease","enrollment":104},{"nctId":"NCT06019728","phase":"PHASE4","title":"A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme","status":"COMPLETED","sponsor":"Sanofi","startDate":"2023-11-10","conditions":"Fabry's Disease","enrollment":8},{"nctId":"NCT05054387","phase":"PHASE4","title":"China Post-marketing Surveillance (PMS) Study of Fabrazyme®","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2021-10-13","conditions":"Fabry Disease","enrollment":22},{"nctId":"NCT04143958","phase":"PHASE4","title":"To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease","status":"WITHDRAWN","sponsor":"Sanofi","startDate":"2020-09","conditions":"Fabry Disease","enrollment":""}],"_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":["Fabrazyme","Fabrazyme®"],"phase":"marketed","status":"active","brandName":"agalsidase beta (GZ419828)","genericName":"agalsidase beta (GZ419828)","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Agalsidase beta is a recombinant human alpha-galactosidase A enzyme that breaks down globotriaosylceramide (Gb3) accumulation in cells. Used for Fabry disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}