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New stroke drug could help patients treated up to 24 hours after symptoms start

NCT ID NCT07324837

Disease control Sponsor: Supergene, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This Phase 3 trial tests a drug called Fortelyzin® (non-immunogenic staphylokinase) in 990 adults with acute ischemic stroke who can be treated between 4.5 and 24 hours after symptoms begin. Participants receive a single injection of the drug or a placebo. The goal is to see if the drug improves functional outcomes, such as being able to live independently, 90 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fortelyzin® (non-immunogenic staphylokinase)
What this could lead to
If successful, this could provide a new treatment option for stroke patients who cannot receive standard therapy within the first few hours, potentially reducing disability.
What could go wrong
This is an early-stage Phase 3 trial, so results may not confirm benefit. There is also a risk of bleeding, as with any clot-busting drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 990 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women aged 18 years and over; 2. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment, including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time"; 3. Pre-stroke modified Rankin scale (mRS) score≤1; 4. Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CT/MRI, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke; 5. Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL; 6. Alberta Stroke Program Early CT score (ASPECTS) \> 6; 7. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive); 8. The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines; 9. Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: 1. Acute ischemic stroke within 4,5 h after symptom onset; 2. Intended to proceed to endovascular treatment; 3. Known hypersensitivity to the non-immunogenic staphylokinase; 4. Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke; 5. Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), and the inability to reduce systolic blood pressure below 180 mmHg or diastolic blood pressure below 105 mmHg; 6. Blood glucose \<2.8 or \>22.2 mmol/L (after blood glucose level correction to the specified values, inclusion of the patient in the study is possible); 7. Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm; 8. Subarachnoid hemorrhage; 9. Major bleeding currently or within the past 6 months; 10. Surgery on the brain or spinal cord in the last 2 months; 11. Punctures of non-compressible arteries and veins in the last 7 days; 12. Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months; 13. Platelet count below 100,000/mm3; 14. Previous stroke or severe traumatic brain injury within 3 months; 15. Unable to perform CT or MRI; 16. History of hemorrhagic stroke or stroke of unspecified genesis; 17. Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion); 18. Concomitant use of indirect oral anticoagulants (warfarin) with INR \> 1.7; 19. Taking direct anticoagulants (heparin, heparinoids) in the previous 48 hours with an APTT value above normal; 20. Taking new oral anticoagulants in the previous 48 hours with a thrombin time value above normal and the impossibility of administering the specific antagonist idarucizumab (for dabigatran) or the presence of anti-Xa activity (for rivaroxaban, apixaban and edoxaban). 21. Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis; 22. Acute pancreatitis; 23. Bacterial endocarditis, pericarditis; 24. Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm; 25. Cancer with an increased risk of bleeding; 26. Major surgeries or severe injuries within the last 14 days, minor surgeries or invasive procedures within the last 10 days; 27. Prolonged or traumatic cardiopulmonary resuscitation (more than 2 minutes); 28. Hemorrhagic diathesis, including renal and hepatic failure; 29. Data on bleeding or acute trauma (fracture) at the time of examination; 30. Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.K. Yeramishantsev Moscow City Clinical Hospital

    NOT_YET_RECRUITING

    Moscow, 129327, Russia

  • Altai Regional Clinical Hospital

    NOT_YET_RECRUITING

    Barnaul, 656024, Russia

  • Chelyabinsk Regional Clinical Hospital No. 3

    NOT_YET_RECRUITING

    Chelyabinsk, Russia

  • City Clinical Hospital of Emergency Medical Care No. 25

    NOT_YET_RECRUITING

    Volgograd, 400138, Russia

  • F.I. Inozemtsev Moscow City Clinical Hospital

    NOT_YET_RECRUITING

    Moscow, 105187, Russia

  • Interregional Clinical and Diagnostic Center

    NOT_YET_RECRUITING

    Kazan', 420101, Russia

  • Irkutsk Regional Clinical Hospital

    RECRUITING

    Irkutsk, 664079, Russia

  • Kaluga Regional Clinical Hospital

    NOT_YET_RECRUITING

    Kaluga, 248007, Russia

  • Krasnogorsk Clinical Hospital

    NOT_YET_RECRUITING

    Krasnogorsk, 143408, Russia

  • L.A. Vorokhobov Moscow City Clinical Hospital No. 67

    NOT_YET_RECRUITING

    Moscow, 123423, Russia

  • Leningradskaya Regional Clinical Hospital

    RECRUITING

    Saint Petersburg, 194291, Russia

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    NOT_YET_RECRUITING

    Moscow, 108814, Russia

  • N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

    NOT_YET_RECRUITING

    Nizhny Novgorod, 603126, Russia

  • N.I. Pirogov Russian National Research Medical University

    NOT_YET_RECRUITING

    Moscow, 117997, Russia

  • Ryazan Regional Clinical Hospital

    NOT_YET_RECRUITING

    Ryazan, Ryazan Oblast, 390039, Russia

  • S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1

    RECRUITING

    Krasnodar, 350086, Russia

  • Sergiev Posad District Hospital

    NOT_YET_RECRUITING

    Sergiyev Posad, 141301, Russia

  • St. Petersburg Hospital for War Veterans

    RECRUITING

    Saint Petersburg, 193079, Russia

  • Sverdlovsk Regional Clinical Hospital No. 1

    RECRUITING

    Yekaterinburg, 620102, Russia

  • Tver Regional Clinical Hospital

    RECRUITING

    Tver', 170036, Russia

  • Ulyanovsk Regional Clinical Hospital

    RECRUITING

    Ulyanovsk, Russia

  • V.I. Voynov Orenburg Regional Clinical Hospital

    RECRUITING

    Orenburg, Russia

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