{"id":"eptacog-alfa-biosimilar","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events (deep vein thrombosis, pulmonary embolism, myocardial infarction)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108334","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Eptacog alfa (recombinant Factor VIIa) is a vitamin K-dependent serine protease that activates the extrinsic coagulation pathway independently of Factor VIII or Factor IX. It binds to tissue factor on cell surfaces and directly activates Factor X, leading to thrombin generation and platelet activation. This mechanism allows hemostasis in patients with Factor VIII or Factor IX deficiency, inhibitors to these factors, or other coagulation disorders.","oneSentence":"Eptacog alfa is a recombinant activated Factor VII that bypasses upstream coagulation defects to directly activate Factor X and initiate thrombin generation for hemostasis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:18.332Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A or B with inhibitors"},{"name":"Factor VII deficiency"},{"name":"Glanzmann thrombasthenia with refractoriness to platelet transfusion"}]},"trialDetails":[{"nctId":"NCT03079063","phase":"PHASE3","title":"Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency","status":"COMPLETED","sponsor":"AryoGen Pharmed Co.","startDate":"2017-03-01","conditions":"Factor VII Deficiency","enrollment":24},{"nctId":"NCT03935334","phase":"PHASE3","title":"Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors","status":"COMPLETED","sponsor":"AryoGen Pharmed Co.","startDate":"2018-07-23","conditions":"Hemophilia A or B With Inhibitor","enrollment":48}],"_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":"phase_3","status":"active","brandName":"Eptacog alfa, biosimilar","genericName":"Eptacog alfa, biosimilar","companyName":"AryoGen Pharmed Co.","companyId":"aryogen-pharmed-co","modality":"Biologic","firstApprovalDate":"","aiSummary":"Eptacog alfa is a biosimilar exogenous protein that targets coagulation factor VII. It is used to treat conditions such as Factor VII Deficiency, Hemophilia A or B With Inhibitor.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}