5 completed, 3 recruiting, 1 terminated. 7 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 4, Recruiting 2, Terminated 1 |
| Phase 2 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset non-immunogenic staphylokinase, Placebo - Ischemic Stroke, Acute | Phase 3 | Recruiting | Supergene, LLC | 990 | 2026-06-09 | 2026-10-01 |
| Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin® - Pulmonary Embolism Acute Massive | Recruiting | Supergene, LLC | 20000 | 2025-06-01 | 2026-07-06 | |
| Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism Non-immunogenic recombinant staphylokinase, Placebo - Pulmonary Embolism | Phase 3 | Recruiting | Supergene, LLC | 486 | 2024-05-23 | 2025-12-05 |
| Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial Recombinant non-immunogenic staphylokinase (Fortelyzin®), surgical methods of treatment - Acute Limb Ischemia | Phase 3 | Completed | Supergene, LLC | 170 | 2022-12-26 | 2026-10-05 |
| Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial Recombinant nonimmunogenic staphylokinase, Placebo - COVID-19 | Phase 2 / Phase 3 | Terminated | Supergene, LLC | 4 | 2021-12-27 | 2023-07-03 |
| Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry) Non-immunogenic staphylokinase - Acute Ischemic Stroke | Completed | Supergene, LLC | 23250 | 2021-03-01 | 2025-12-05 | |
| Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE Recombinant nonimmunogenic staphylokinase, Alteplase - Massive Pulmonary Embolism | Phase 3 | Completed | Supergene, LLC | 310 | 2020-12-15 | 2025-04-02 |
| Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS Recombinant staphylokinase, Alteplase - Ischemic Stroke | Phase 3 | Completed | Supergene, LLC | 336 | 2017-03-18 | 2025-04-02 |
| Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI Recombinant staphylokinase, Tenecteplase - Myocardial Infarction | Phase 3 | Completed | Supergene, LLC | 382 | 2014-05-16 | 2025-03-20 |
Ischemic Stroke (3) · Pulmonary Embolism (2) · COVID-19 (1) · Myocardial Infarction (1) · Thrombosis (1)
Tissue Plasminogen Activator (2) · Saline Solution (1) · Tenecteplase (1)
Russia (9)
Sergey S Markin, MD, PhD (2) · Sergey S. Markin, MD, PhD (2) · Alexander I Kirienko, MD, PhD (1) · Evgenii I Gusev, MD, PhD (1) · Igor I. Zatevakhin, MD, PhD (1) · Nikolay A. Shamalov, MD, PhD Prof (1) · Nikolay A. Shamalov, MD, prof (1) · Segey S Markin, MD, Prof. (1) · Sergey N. Tereschenko, MD, PhD (1) · Sergey N. Tereschenko, MD, Prof. (1) · Sergey S. Markin, MD, Prof. (1) · Sergey S. Markin, MD, prof (1) · Valentin A. Markov, MD, Prof. (1)
PMID 34418399, PMID 40391253, PMID 39454884, PMID 41293810, PMID 41243072, PMID 41805599