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Non-immunogenic recombinant staphylokinase
Non-immunogenic recombinant staphylokinase is a fibrinolytic enzyme that directly activates plasminogen to plasmin, dissolving blood clots without triggering immune responses.
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.
At a glance
| Generic name | Non-immunogenic recombinant staphylokinase |
|---|---|
| Also known as | Fortelyzin® |
| Sponsor | Supergene, LLC |
| Drug class | Fibrinolytic agent / Plasminogen activator |
| Target | Plasminogen |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Acute myocardial infarction
- Acute ischemic stroke
- Pulmonary embolism
- Deep vein thrombosis
Common side effects
- Bleeding
- Intracranial hemorrhage
- Hypotension
- Allergic reactions
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)
- Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (PHASE3)
- Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial (PHASE2, PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Non-immunogenic recombinant staphylokinase CI brief — competitive landscape report
- Non-immunogenic recombinant staphylokinase updates RSS · CI watch RSS
- Supergene, LLC portfolio CI