{"id":"fabrazyme-agalsidase-beta","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitiv"],"safetySignals":[{"date":"","signal":"BLOOD PRESSURE DECREASED","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"CELLULITIS","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"ABSCESS NECK","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ACUTE ABDOMEN","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ALTERED STATE OF CONSCIOUSNESS","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"AORTIC ANEURYSM","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ATRIAL FIBRILLATION","source":"FDA FAERS","actionTaken":"Reported 1 times"}],"drugInteractions":[{"drug":"Anticoagulants","action":"Monitor","effect":"May increase the risk of bleeding due to the potential for Fabrazyme to affect platelet function."},{"drug":"Immunosuppressants","action":"Monitor","effect":"May reduce the efficacy of Fabrazyme by decreasing immune response to the enzyme replacement therapy."},{"drug":"Anti-inflammatory drugs","action":"Monitor","effect":"May alter the inflammatory response and affect the tolerability or efficacy of Fabrazyme."}],"commonSideEffects":[],"contraindications":["None."],"specialPopulations":{"Pregnancy":"Available data from a pregnancy sub-study within the Fabry Disease registry, post-marketing case reports, and case series with FABRAZYME use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Reproduction studies performed in rats at doses up to 68 times the human dose have revealed no evidence of effects on embryo-fetal development.","Geriatric use":"Clinical studies of FABRAZYME did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.","Paediatric use":"The safety and effectiveness of FABRAZYME have been established in pediatric patients based on adequate and well-controlled studies in adults, a single-arm, open-label study in 16 pediatric patients with Fabry disease aged 8 to 16 years, and additional data in 24 patients with Fabry disease aged 2 to 7 years. The overall safety profile of FABRAZYME was similar between the pediatric and the adult population.","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":["r-hαGAL","Fabrazyme"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Fabrazyme (agalsidase beta)","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:11:35.080584+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:11:41.868515+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:11:35.097085+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Fabrazyme (agalsidase beta)","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:11:42.626470+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Globotriosylceramide hydrolytic enzyme","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:43.657551+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108888/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:43.557623+00:00"}},"offLabel":[],"timeline":[{"date":"1996-01-01","type":"positive","milestone":"Discovery and IND filing","regulator":"none"},{"date":"1998-06-01","type":"positive","milestone":"Phase 1/2 trials start","regulator":"none"},{"date":"2000-03-01","type":"positive","milestone":"Phase 3 trials start","regulator":"none"},{"date":"2003-04-24","type":"positive","milestone":"EMA approval","regulator":"EMA"},{"date":"2003-08-14","type":"positive","milestone":"FDA approval","regulator":"FDA"},{"date":"2010-07-01","type":"positive","milestone":"Label expansion for pediatric patients","regulator":"FDA"},{"date":"2014-01-01","type":"neutral","milestone":"Patent expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"Fabrazyme (agalsidase beta) is a marketed enzyme replacement therapy developed by Genzyme (Sanofi) for Fabry disease in patients aged 2 years and older. The drug provides exogenous α-galactosidase A to reduce pathogenic GL-3 accumulation in lysosomes. With 38 clinical trials and 293 publications, Fabrazyme represents a foundational treatment for this rare lysosomal storage disorder. The drug demonstrates clinical differentiation through its established safety and efficacy profile in both pediatric and adult populations. As a pioneering enzyme replacement therapy, Fabrazyme maintains significant commercial importance in the rare disease market, though newer alternatives have emerged.","ecosystem":[],"mechanism":{"target":"α-galactosidase A (GLA gene product); substrate: globotriaosylceramide (GL-3)","novelty":"First-in-class","modality":"Recombinant protein","drugClass":"Enzyme replacement therapy (ERT); recombinant enzyme","explanation":"","oneSentence":"","technicalDetail":"Agalsidase beta is a recombinant human α-galactosidase A produced in Chinese hamster ovary (CHO) cells. The enzyme is administered as an intravenous infusion at a dose of 1.15 mg/kg body weight every two weeks. Following infusion, the enzyme undergoes receptor-mediated endocytosis and is trafficked to lysosomes via the mannose-6-phosphate receptor pathway, where it catalyzes the hydrolysis of terminal α-galactosyl moieties from GL-3 and related glycosphingolipids."},"_scrapedAt":"2026-03-27T23:30:19.647Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$247.153 / unit","peakSalesEstimate":"$0.5B"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:11:45.410091+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"ELFABRIO","slug":"pegunigalsidase-alfa","company":"Chiesi USA, Inc.","advantage":"Same class (Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC])","genericName":"PEGUNIGALSIDASE ALFA"},{"name":"Fabrazyme","slug":"agalsidase-beta","company":"Genzyme Corporation","advantage":"Same class (Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC])","genericName":"AGALSIDASE BETA"}],"indications":{"approved":[{"name":"Treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"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":"NCT00196742","phase":"","title":"Fabry Disease Registry & Pregnancy Sub-registry","status":"RECRUITING","sponsor":"Genzyme, a Sanofi Company","startDate":"2001-07-31","conditions":"Fabry Disease","enrollment":9000},{"nctId":"NCT05843916","phase":"PHASE3","title":"Switch Over Study of Biosimilar Agalsidase Beta for Fabry 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Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion","status":"COMPLETED","sponsor":"Bio Sidus SA","startDate":"2021-10-23","conditions":"Fabry Disease","enrollment":24},{"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":"NCT06052800","phase":"","title":"Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2023-09-13","conditions":"Fabry Disease","enrollment":78},{"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},{"nctId":"NCT00230607","phase":"PHASE4","title":"Study of the Effects of Fabrazyme Treatment on Lactation and Infants","status":"TERMINATED","sponsor":"Genzyme, a Sanofi Company","startDate":"2006-05-28","conditions":"Fabry Disease, Alpha Galactosidase A Deficiency","enrollment":7},{"nctId":"NCT05698901","phase":"","title":"Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease","status":"RECRUITING","sponsor":"Mackay Memorial Hospital","startDate":"2023-09-19","conditions":"Fabry Disease","enrollment":150},{"nctId":"NCT02795676","phase":"PHASE3","title":"Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function","status":"COMPLETED","sponsor":"Protalix","startDate":"2016-06","conditions":"Fabry Disease","enrollment":78},{"nctId":"NCT03180840","phase":"PHASE3","title":"Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks","status":"COMPLETED","sponsor":"Protalix","startDate":"2017-07-10","conditions":"Fabry Disease","enrollment":30},{"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":0},{"nctId":"NCT01031173","phase":"","title":"Treatment Protocol of Replagal for Patients With Fabry Disease","status":"NO_LONGER_AVAILABLE","sponsor":"Shire","startDate":"","conditions":"Fabry Disease","enrollment":""},{"nctId":"NCT01268241","phase":"","title":"The Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement in Patients With Anderson-Fabry Disease","status":"COMPLETED","sponsor":"CENTOGENE GmbH Rostock","startDate":"2010-12","conditions":"Fabry Disease, Fabry´s Disease, Anderson-Fabry Disease","enrollment":200},{"nctId":"NCT01196871","phase":"PHASE2","title":"Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease","status":"COMPLETED","sponsor":"Amicus Therapeutics","startDate":"2011-02-02","conditions":"Fabry Disease","enrollment":20},{"nctId":"NCT01218659","phase":"PHASE3","title":"Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease","status":"COMPLETED","sponsor":"Amicus Therapeutics","startDate":"2011-09-08","conditions":"Fabry Disease","enrollment":68},{"nctId":"NCT02969200","phase":"","title":"Fabry: Renal Function During Long-term ERT by 51Cr-EDTA Clearance","status":"COMPLETED","sponsor":"Ulla Feldt-Rasmussen","startDate":"2015-04","conditions":"Fabry Disease","enrollment":52},{"nctId":"NCT02908724","phase":"","title":"Cardiac Involvement in Adult Patients With Fabry Disease; Relation to Enzyme Replacement 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Treated With Agalsidase Alfa Who Switch to Agalsidase Beta","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2012-04","conditions":"Fabry Disease","enrollment":15},{"nctId":"NCT00312767","phase":"PHASE4","title":"A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.","status":"WITHDRAWN","sponsor":"Genzyme, a Sanofi Company","startDate":"2006-04","conditions":"Fabry Disease","enrollment":0},{"nctId":"NCT00074984","phase":"PHASE4","title":"A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2001-02","conditions":"Fabry Disease","enrollment":82},{"nctId":"NCT00074971","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease","status":"COMPLETED","sponsor":"Genzyme, a Sanofi 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a single-centre analysis.","journal":"Clinical kidney journal"},{"date":"2026 Jan 21","pmid":"41313298","title":"Long-Term Cardiac Stability Despite Late Enzyme Replacement Therapy in Fabry Disease With Severe Renal Involvement.","journal":"JACC. Case reports"},{"date":"2025 Nov","pmid":"41246852","title":"Historical Control Analysis Demonstrates Greater Long-Term Reduction in Plasma Globotriaosylceramide (Gb3) by Venglustat Compared With Placebo or Agalsidase Beta in Male Patients With Classic Fabry Disease.","journal":"Molecular genetics & genomic medicine"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Fabrazyme (agalsidase beta)","genericName":"Fabrazyme (agalsidase beta)","companyName":"Genzyme, a Sanofi Company","companyId":"genzyme-a-sanofi-company","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:11:45.410091+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}