{"id":"prx-102-pegunigalsidase-alfa","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Pyrexia"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL4297801","moleculeType":"Enzyme"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"PRX-102 is an enzyme replacement therapy (ERT) designed to address the deficiency of α-galactosidase A in Fabry disease patients. The pegylation extends the drug's half-life and reduces immunogenicity compared to non-pegylated versions. By replacing the missing or deficient enzyme, PRX-102 catalyzes the hydrolysis of Gb3 and related glycosphingolipids, reducing their pathological accumulation in tissues and potentially slowing disease progression.","oneSentence":"PRX-102 is a pegylated recombinant human α-galactosidase A enzyme that breaks down accumulated globotriaosylceramide (Gb3) in cells affected by Fabry disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:30:38.948Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fabry disease (in development)"}]},"trialDetails":[{"nctId":"NCT03566017","phase":"PHASE3","title":"Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-09-16","conditions":"Fabry Disease","enrollment":97},{"nctId":"NCT06328608","phase":"PHASE2, PHASE3","title":"A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease","status":"RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2025-07-29","conditions":"Fabry Disease","enrollment":22},{"nctId":"NCT05710692","phase":"PHASE2, PHASE3","title":"Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease","status":"RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-08-01","conditions":"Fabry Disease","enrollment":16},{"nctId":"NCT03614234","phase":"PHASE3","title":"Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-11-13","conditions":"Fabry Disease","enrollment":29},{"nctId":"NCT01981720","phase":"PHASE1, PHASE2","title":"Extension Study of PRX-102 for up to 60 Months","status":"COMPLETED","sponsor":"Protalix","startDate":"2014-01-16","conditions":"Fabry Disease","enrollment":15},{"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":"NCT03018730","phase":"PHASE3","title":"Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)","status":"COMPLETED","sponsor":"Protalix","startDate":"2017-05-17","conditions":"Fabry Disease","enrollment":22},{"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":"NCT02921620","phase":"PHASE3","title":"Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease","status":"WITHDRAWN","sponsor":"Protalix","startDate":"2017-07","conditions":"Fabry Disease","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["pegunigalsidase alfa","Recombinant human alpha galactosidase-A"],"phase":"phase_3","status":"active","brandName":"PRX-102 (pegunigalsidase alfa)","genericName":"PRX-102 (pegunigalsidase alfa)","companyName":"Protalix","companyId":"protalix","modality":"Biologic","firstApprovalDate":"","aiSummary":"PRX-102 is a pegylated recombinant human α-galactosidase A enzyme that breaks down accumulated globotriaosylceramide (Gb3) in cells affected by Fabry disease. Used for Fabry disease (in development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}