{"id":"non-immunogenic-recombinant-staphylokinase","safety":{"commonSideEffects":[{"rate":null,"effect":"Bleeding"},{"rate":null,"effect":"Intracranial hemorrhage"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Allergic reactions"}]},"_chembl":{"chemblId":"CHEMBL4297989","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Staphylokinase is a bacterial plasminogen activator that converts plasminogen to its active form, plasmin, which degrades fibrin in thrombi. The non-immunogenic variant has been engineered to reduce or eliminate immunogenicity, allowing for repeated dosing without antibody formation. This makes it suitable for thrombolytic therapy in acute thrombotic conditions.","oneSentence":"Non-immunogenic recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots without triggering immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:13.513Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myocardial infarction"},{"name":"Acute ischemic stroke"},{"name":"Pulmonary embolism"},{"name":"Deep vein thrombosis"}]},"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":"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":"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fortelyzin®"],"phase":"phase_3","status":"active","brandName":"Non-immunogenic recombinant staphylokinase","genericName":"Non-immunogenic recombinant staphylokinase","companyName":"Supergene, LLC","companyId":"supergene-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Non-immunogenic recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots without triggering immune responses. Used for Acute myocardial infarction, Acute ischemic stroke, Pulmonary embolism.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}