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Recombinant Staphylokinase
Recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots.
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.
At a glance
| Generic name | Recombinant Staphylokinase |
|---|---|
| Also known as | r-SAK single intravenous injection for early treatment of acute myocardial infarction, Fortelyzin |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Drug class | Fibrinolytic agent / Thrombolytic |
| Target | Plasminogen |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Acute myocardial infarction
- Acute ischemic stroke
- Venous thromboembolism
Common side effects
- Bleeding
- Hypotension
- Allergic reaction
Key clinical trials
- Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (PHASE3)
- Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism (PHASE3)
- Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial (PHASE3)
- Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS (PHASE3)
- Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (PHASE3)
- Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI (PHASE3)
- Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction (PHASE4)
- Prolonged Clinical Follow-up of OPTIMA-5 (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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