{"id":"rdd-to-palynziq","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Anti-drug antibody formation"},{"rate":null,"effect":"Arthralgia"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Palynziq catalyzes the conversion of phenylalanine to trans-cinnamic acid and ammonia, thereby lowering circulating phenylalanine concentrations. This enzyme replacement therapy addresses the underlying metabolic defect in phenylketonuria (PKU), where patients lack functional phenylalanine hydroxylase, allowing them to tolerate a more normal diet while maintaining safe phenylalanine levels.","oneSentence":"Palynziq is a recombinant phenylalanine ammonia-lyase (PAL) enzyme that breaks down phenylalanine, reducing blood phenylalanine levels in patients with phenylketonuria.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:37:00.679Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Phenylketonuria (PKU) in patients with blood phenylalanine levels ≥600 μmol/L"}]},"trialDetails":[{"nctId":"NCT06780332","phase":"PHASE4","title":"Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq","status":"RECRUITING","sponsor":"BioMarin Pharmaceutical","startDate":"2025-01","conditions":"Phenylketonuria, PKU","enrollment":10}],"_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":[],"phase":"marketed","status":"active","brandName":"RDD to Palynziq","genericName":"RDD to Palynziq","companyName":"BioMarin Pharmaceutical","companyId":"biomarin-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Palynziq is a recombinant phenylalanine ammonia-lyase (PAL) enzyme that breaks down phenylalanine, reducing blood phenylalanine levels in patients with phenylketonuria. Used for Phenylketonuria (PKU) in patients with blood phenylalanine levels ≥600 μmol/L.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}