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non-immunogenic staphylokinase
Non-immunogenic staphylokinase is a genetically engineered enzyme that catalyzes the conversion of plasminogen to plasmin, thereby dissolving blood clots.
Non-immunogenic staphylokinase is a genetically engineered enzyme that catalyzes the conversion of plasminogen to plasmin, thereby dissolving blood clots. Used for Treatment of acute ischemic stroke, Treatment of pulmonary embolism.
At a glance
| Generic name | non-immunogenic staphylokinase |
|---|---|
| Also known as | Fortelyzin® |
| Sponsor | Supergene, LLC |
| Drug class | Fibrinolytic agent |
| Target | Plasminogen |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This process is crucial in treating conditions associated with excessive clotting, such as pulmonary embolism and deep vein thrombosis. Unlike traditional staphylokinase, non-immunogenic staphylokinase has been engineered to minimize the risk of an immune response, allowing for repeated administration if necessary.
Approved indications
- Treatment of acute ischemic stroke
- Treatment of pulmonary embolism
Common side effects
- Hemorrhage
- 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)
- Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry)
- 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)
- Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
- 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)
- Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
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 staphylokinase CI brief — competitive landscape report
- non-immunogenic staphylokinase updates RSS · CI watch RSS
- Supergene, LLC portfolio CI