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New stroke drug shows promise in major trial

NCT ID NCT05691244

Disease control Sponsor: Pharmazz, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether sovateltide, a drug that stimulates ETB receptors, can improve recovery after an acute ischemic stroke. About 514 adults aged 18-80 will receive either sovateltide or a placebo alongside standard care. The main goal is to see if more patients achieve a good functional outcome (score 0-2 on the modified Rankin Scale) 90 days after treatment.

What this could mean

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

Active substance
sovateltide (also called PMZ-1620)
What this could lead to
If successful, sovateltide could become a new treatment to help people recover better after a stroke, reducing long-term disability.
What could go wrong
This is a Phase 3 trial, but earlier studies were small and mostly in India. The drug may not work as well in a larger, more diverse group, and side effects are still being studied.

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 514 people

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

Started

Jul 2025

Expected to finish

Dec 2027

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 to 80 years

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: A patient will be eligible for inclusion in the study if he/she fulfills the following criteria: 1. Adult males or females aged 18 - 80 years of age. 2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures. 3. A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan. 4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of Consciousness (1A) score \<2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2. 5. The patient is \<24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal. 6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits. Exclusion Criteria: A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria: 1. Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques. 2. Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2). 3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan. 4. Known pregnancy and lactating women. 5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study. 6. Concurrent participation in any other therapeutic clinical trial. 7. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient.

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Conditions

The condition(s) this trial relates to.

cerebral infarction ischemic stroke stroke disorder

As listed by the trial registrant

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

Acute ischemic stroke Cerebral stroke

How to take part

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

  1. The places running it

    54 sites in 4 countries. 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

  • CHI Memorial Neuroscience Institute

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Charite-Universitaetsmedizin Berlin

    RECRUITING

    Berlin, State of Berlin, 12203, Germany

  • Complejo Hospitalario Universitario de Albacete

    RECRUITING

    Albacete, Castille-La Mancha, 2006, Spain

  • Fairfield General Hospital

    RECRUITING

    Bury, Bury, BL9 7TD, United Kingdom

  • Guilford Neurologic Associates Inc

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Hackensack University Medical Center at Paramus

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Santiago

    RECRUITING

    Santiago, 15706, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico Universitario Virgen de Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Joan XXIII

    RECRUITING

    Tarragona, Tarragona, 43005, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Infanta Cristina (HUB)

    RECRUITING

    Badajoz, 06080, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Madrid, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI

    RECRUITING

    Newcastle, NE1 4LP, United Kingdom

  • Houston Medical Neurological Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • Instituto de Investigación Biomédica de A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, London, SE5 9RS, United Kingdom

  • Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151

    RECRUITING

    Recklinghausen, Recklinghausen, 45657, Germany

  • Klinikum Altenburger Land GmbH

    RECRUITING

    Altenburg, Altenburg, 04600, Germany

  • Klinikum der Stadt Ludwigshafen gGmbh

    RECRUITING

    Rhein, Ludwigshafen Am, 67063, Germany

  • London North West University Healthcare NHS Trust - Northwick Park Hospital

    RECRUITING

    Harrow, HA1 3UJ, United Kingdom

  • Medical Imbrain S.L.

    RECRUITING

    Melilla, 52001, Spain

  • Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Mercy Medical Group

    RECRUITING

    Carmichael, California, 95608, United States

  • Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik

    RECRUITING

    Minden, North Rhine-Westphalia, 32427, Germany

  • National Hospital for Neurology & Neurosurgery

    RECRUITING

    London, London, NW1 2BU, United Kingdom

  • New Cross Hospital - Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, Wolverhampton, WV10 0QP, United Kingdom

  • OSU Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Penn State Health Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • RHON-KLINIKUM Campus Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, 97616, Germany

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • SSM Health Neurosciences

    RECRUITING

    Bridgeton, Missouri, 63044, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. George's University Hospitals

    RECRUITING

    London, London, SW17 0QT, United Kingdom

  • St. John's Regional Medical Center

    RECRUITING

    Oxnard, California, 93030, United States

  • The University of Arizona - College of Medicine

    RECRUITING

    Tucson, Arizona, 85719, United States

  • UPMC Presbyterian Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitaetsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Goettingen

    RECRUITING

    Göttingen, Lower Saxony, 37075, Germany

  • University Hospital Southampton

    RECRUITING

    Southampton, Southampton, SO16 6YD, United Kingdom

  • University Hospital Tuebingen

    RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Essen AöR

    RECRUITING

    Essen, 45147, Germany

  • Universitätsklinikum Schleswig-Holstein AöR

    RECRUITING

    Lübeck, 23538, Germany

  • Wellstar Kennestone Hospital

    RECRUITING

    Marietta, Georgia, 30060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.