{"id":"turoctocog-alfa-pegol-n8-gp","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (factor VIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"The drug is a pegylated (polyethylene glycol-conjugated) version of recombinant factor VIII that functions as a replacement therapy for patients with hemophilia A who lack functional factor VIII. The PEGylation modification extends the drug's circulating half-life compared to standard recombinant factor VIII, reducing dosing frequency and improving patient convenience. Factor VIII is essential for the intrinsic coagulation pathway, enabling thrombin generation and clot formation.","oneSentence":"Turoctocog alfa pegol is a recombinant human coagulation factor VIII with extended half-life achieved through PEGylation, which replaces deficient clotting factor in hemophilia A patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:54:32.492Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (prevention and treatment of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT05082116","phase":"PHASE3","title":"Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2021-09-27","conditions":"Haemophilia A","enrollment":36},{"nctId":"NCT02137850","phase":"PHASE3","title":"Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2014-06-26","conditions":"Congenital Bleeding Disorder, Haemophilia A","enrollment":124},{"nctId":"NCT04574076","phase":"","title":"A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®","status":"ENROLLING_BY_INVITATION","sponsor":"Novo Nordisk A/S","startDate":"2020-10-23","conditions":"Haemophilia A","enrollment":60},{"nctId":"NCT04334057","phase":"","title":"Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2021-03-31","conditions":"Haemophilia A","enrollment":23},{"nctId":"NCT05621746","phase":"","title":"An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct","status":"RECRUITING","sponsor":"Novo Nordisk A/S","startDate":"2022-11-23","conditions":"Haemophilia A","enrollment":100},{"nctId":"NCT03528551","phase":"PHASE3","title":"A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2018-04-30","conditions":"Congenital Bleeding Disorder, Haemophilia A","enrollment":160},{"nctId":"NCT01731600","phase":"PHASE3","title":"A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2013-02-20","conditions":"Congenital Bleeding Disorder, Haemophilia A","enrollment":68},{"nctId":"NCT02994407","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2017-01-30","conditions":"Congenital Bleeding Disorder, Haemophilia A","enrollment":50},{"nctId":"NCT02920398","phase":"PHASE1","title":"A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2016-10-04","conditions":"Congenital Bleeding Disorder, Haemophilia A","enrollment":21}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":32,"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":"Turoctocog alfa pegol (N8-GP)","genericName":"Turoctocog alfa pegol (N8-GP)","companyName":"Novo Nordisk A/S","companyId":"novo-nordisk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Turoctocog alfa pegol is a recombinant human coagulation factor VIII with extended half-life achieved through PEGylation, which replaces deficient clotting factor in hemophilia A patients. Used for Hemophilia A (prevention and treatment of bleeding episodes).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}