{"id":"fabagal-agalsidase-beta","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fabry disease is caused by mutations in the GLA gene, leading to deficiency of the lysosomal enzyme α-galactosidase A. This deficiency causes pathological accumulation of Gb3 in multiple tissues including the heart, kidneys, and nervous system. Agalsidase beta is a recombinant replacement enzyme that catalyzes the degradation of Gb3, reducing tissue burden and slowing disease progression.","oneSentence":"Agalsidase beta is a recombinant human enzyme that replaces deficient α-galactosidase A, breaking down accumulated globotriaosylceramide (Gb3) in cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:46:45.561Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fabry disease (α-galactosidase A deficiency)"}]},"trialDetails":[{"nctId":"NCT06880250","phase":"","title":"Efficacy and Safety of Enzyme Replacement Therapy in Patients With Fabry Disease","status":"ENROLLING_BY_INVITATION","sponsor":"NPO Petrovax","startDate":"2025-03-24","conditions":"Fabry Disease","enrollment":100},{"nctId":"NCT06081062","phase":"PHASE3","title":"Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease","status":"RECRUITING","sponsor":"ISU Abxis Co., Ltd.","startDate":"2023-04-14","conditions":"Fabry Disease","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":293,"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":"Fabagal® (Agalsidase beta)","genericName":"Fabagal® (Agalsidase beta)","companyName":"ISU Abxis Co., Ltd.","companyId":"isu-abxis-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"Agalsidase beta is a recombinant human enzyme that replaces deficient α-galactosidase A, breaking down accumulated globotriaosylceramide (Gb3) in cells. Used for Fabry disease (α-galactosidase A deficiency).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}