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

NCT ID NCT07324837

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Altai Regional Clinical Hospital

    NOT_YET_RECRUITING

    Barnaul, 656024, Russia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chelyabinsk Regional Clinical Hospital No. 3

    NOT_YET_RECRUITING

    Chelyabinsk, Russia

    Contact Email: •••••@•••••

    Contact

  • City Clinical Hospital of Emergency Medical Care No. 25

    NOT_YET_RECRUITING

    Volgograd, 400138, Russia

    Contact Email: •••••@•••••

    Contact

  • Interregional Clinical and Diagnostic Center

    NOT_YET_RECRUITING

    Kazan', 420101, Russia

    Contact Email: •••••@•••••

    Contact

  • Irkutsk Regional Clinical Hospital

    NOT_YET_RECRUITING

    Irkutsk, 664079, Russia

    Contact Email: •••••@•••••

    Contact

  • Kaluga Regional Clinical Hospital

    NOT_YET_RECRUITING

    Kaluga, 248007, Russia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Leningradskaya Regional Clinical Hospital

    NOT_YET_RECRUITING

    Saint Petersburg, 194291, Russia

    Contact Email: •••••@•••••

    Contact

  • N.I. Pirogov Russian National Research Medical University

    NOT_YET_RECRUITING

    Moscow, 117997, Russia

    Contact Email: •••••@•••••

    Contact

  • Ryazan Regional Clinical Hospital

    NOT_YET_RECRUITING

    Ryazan, Ryazan Oblast, 390039, Russia

    Contact Email: •••••@•••••

    Contact

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

    NOT_YET_RECRUITING

    Krasnodar, 350086, Russia

    Contact Email: •••••@•••••

    Contact

  • Sergiev Posad District Hospital

    NOT_YET_RECRUITING

    Sergiyev Posad, 141301, Russia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Sverdlovsk Regional Clinical Hospital No. 1

    NOT_YET_RECRUITING

    Yekaterinburg, 620102, Russia

    Contact Email: •••••@•••••

    Contact

  • Tver Regional Clinical Hospital

    NOT_YET_RECRUITING

    Tver', 170036, Russia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ulyanovsk Regional Clinical Hospital

    NOT_YET_RECRUITING

    Ulyanovsk, Russia

    Contact Email: •••••@•••••

    Contact

  • V.I. Voynov Orenburg Regional Clinical Hospital

    RECRUITING

    Orenburg, Russia

    Contact Email: •••••@•••••

    Contact