{"id":"recombinant-staphylokinase","safety":{"commonSideEffects":[{"rate":null,"effect":"Bleeding"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Allergic reaction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Staphylokinase is a bacterial protein produced by Staphylococcus aureus that forms a 1:1 complex with plasminogen, converting it to the active protease plasmin. Plasmin then degrades fibrin in blood clots, leading to thrombolysis. Unlike tissue plasminogen activator (tPA), staphylokinase has direct plasminogen-activating activity and may have a more favorable safety profile with reduced systemic fibrinogenolysis.","oneSentence":"Recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:04:24.388Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myocardial infarction"},{"name":"Acute ischemic stroke"},{"name":"Venous thromboembolism"}]},"trialDetails":[{"nctId":"NCT07324837","phase":"PHASE3","title":"Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset","status":"NOT_YET_RECRUITING","sponsor":"Supergene, LLC","startDate":"2026-02-01","conditions":"Ischemic Stroke, Acute","enrollment":990},{"nctId":"NCT06362746","phase":"PHASE3","title":"Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism","status":"RECRUITING","sponsor":"Supergene, LLC","startDate":"2024-05-23","conditions":"Pulmonary Embolism","enrollment":486},{"nctId":"NCT05372718","phase":"PHASE3","title":"Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial","status":"RECRUITING","sponsor":"Supergene, LLC","startDate":"2022-12-26","conditions":"Acute Limb Ischemia","enrollment":170},{"nctId":"NCT03151993","phase":"PHASE3","title":"Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS","status":"COMPLETED","sponsor":"Supergene, LLC","startDate":"2017-03-18","conditions":"Ischemic Stroke","enrollment":336},{"nctId":"NCT04688320","phase":"PHASE3","title":"Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE","status":"COMPLETED","sponsor":"Supergene, LLC","startDate":"2020-12-15","conditions":"Massive Pulmonary Embolism","enrollment":310},{"nctId":"NCT02301910","phase":"PHASE3","title":"Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI","status":"COMPLETED","sponsor":"Supergene, LLC","startDate":"2014-05-16","conditions":"Myocardial Infarction","enrollment":382},{"nctId":"NCT05410925","phase":"PHASE4","title":"Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2023-04-08","conditions":"ST Elevation Myocardial Infarction","enrollment":2260},{"nctId":"NCT05649696","phase":"PHASE4","title":"Prolonged Clinical Follow-up of OPTIMA-5","status":"COMPLETED","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2021-10-29","conditions":"ST-segment Elevation Myocardial Infarction (STEMI)","enrollment":210},{"nctId":"NCT05978791","phase":"","title":"Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human Arterial Thrombus","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2023-10-11","conditions":"Arterial Thrombosis","enrollment":24},{"nctId":"NCT05135546","phase":"PHASE2, PHASE3","title":"Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial","status":"TERMINATED","sponsor":"Supergene, LLC","startDate":"2021-12-27","conditions":"COVID-19","enrollment":4},{"nctId":"NCT05023681","phase":"PHASE4","title":"The OPTIMA-5 Trail","status":"COMPLETED","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2021-10-29","conditions":"Acute Myocardial Infarction","enrollment":200},{"nctId":"NCT01305226","phase":"PHASE3","title":"A Trial Using Double-Bolus THR-100 Versus Streptokinase","status":"COMPLETED","sponsor":"Bharat Biotech International Limited","startDate":"2010-10","conditions":"Acute Myocardial Infarction","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":109,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["r-SAK single intravenous injection for early treatment of acute myocardial infarction","Fortelyzin"],"phase":"marketed","status":"active","brandName":"Recombinant Staphylokinase","genericName":"Recombinant Staphylokinase","companyName":"The First Affiliated Hospital with Nanjing Medical University","companyId":"the-first-affiliated-hospital-with-nanjing-medical-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots. Used for Acute myocardial infarction, Acute ischemic stroke, Venous thromboembolism.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}