{"id":"nonacog-alfa-genetical-recombination","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT01154231"],"aliases":[],"patents":[],"pricing":[],"allNames":"nonacog alfa (genetical recombination)","offLabel":[],"timeline":[],"aiSummary":"Nonacog Alfa is a recombinant Factor IX used to treat hemophilia B by replacing the missing clotting factor. As a genetically engineered protein, it provides effective hemostasis in patients with Factor IX deficiency, offering consistent potency and reduced infection risk compared to plasma-derived alternatives.","brandName":"Nonacog Alfa (Genetical Recombination)","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered ","explanation":"Hemophilia B is a rare inherited bleeding disorder caused by insufficient levels of clotting Factor IX, a protein essential for the blood coagulation cascade. Without adequate Factor IX, the body cannot form stable blood clots, leading to prolonged bleeding from injuries and spontaneous bleeding into joints and muscles. Nonacog Alfa is a laboratory-engineered version of Factor IX created through recombinant DNA technology, allowing manufacturers to produce it in large quantities without relying on donated blood plasma.\n\nWhen administered intravenously, Nonacog Alfa circulates through the bloodstream and integrates into the body's natural clotting pathway, effectively replacing the missing or deficient Factor IX. This allows the coagulation cascade to proceed normally, enabling blood to clot at appropriate times. The recombinant approach means each dose contains precisely measured Factor IX with consistent purity and strength, eliminating batch-to-batch variability seen in plasma-derived products.\n\nBy restoring Factor IX activity, Nonacog Alfa prevents bleeding episodes and controls active bleeding in hemophilia B patients. Treatment typically involves regular infusions given at home or in clinical settings, with dosing tailored to individual patient needs. The recombinant formulation reduces risks associated with blood-borne pathogen transmission that existed with older plasma-derived factor replacement therapies.","oneSentence":"Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered ","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"nonacog-alfa-genetical-recombination","indications":{"approved":[{"name":"Hereditary factor IX deficiency disease","diseaseId":"hereditary-factor-ix-deficiency-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[{"name":"Hemophilia B","phase":"preclinical","trialId":"","patients":null,"diseaseId":"rare-disease","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01154231","phase":"N/A","title":"BeneFIX Drug Use Results Survey [All-Case Surveillance]","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":314,"indication":"Hemophilia B","completionDate":"2014-08","primaryEndpoint":"The survey is intended to investigate the following matters, etc."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2108348"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Rare Disease"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}