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New stroke drug shows promise in major trial

NCT ID NCT05953480

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a new biologic drug called redasemtide in 680 adults who have had an acute ischemic stroke. Participants receive either the drug or a placebo within 25 hours of their stroke. The goal is to see if redasemtide improves recovery and reduces disability at 90 days. The trial includes people who can and cannot receive standard clot-busting treatments.

What this could mean

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

Active substance
redasemtide (a biologic drug given by injection)
What this could lead to
If successful, this could provide a new treatment option to improve recovery and reduce long-term disability after a stroke.
What could go wrong
This is a mid-stage trial, so results may not confirm benefit. The drug is given within 25 hours of stroke onset, which is a narrow window, 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

680 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2026

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.

Key Inclusion Criteria: * Able to initiate study intervention within 25 hours of stroke onset * Cohort A: Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke. * Cohort B: Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke. * Cohort A: If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable, defined as absence of an increase or decrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS score should be 6 to 22 at baseline. * Cohort B: In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second/baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy. * Medically stable at the time of enrollment except for primary disease and complications associated with it, according to the judgment of the investigator. In addition, hospitalization during the Follow-up Period is not anticipated, and the participant appears likely to be able to complete the study. Medically stable is defined as disease not requiring significant change in therapy for 3 months following enrollment. Key Exclusion Criteria: * Any disease or neurological disorder that, in the opinion of the investigator, would interfere with the conduct of the study * A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert, responds only with reflex motor or autonomic effects, or totally unresponsive, flaccid, and areflexic) * Disability corresponding to a mRS score of ≥2 before the onset of stroke * A history of stroke (excluding transient ischemic attack), history of or current intracranial hemorrhage, or head trauma that caused neurological effects within 90 days prior to obtaining informed consent * Participants with an ischemic stroke in cerebellum and/or brain stem as the main infarction site * Diagnosis of a current transient ischemic attack * Unable to undergo either computed tomography or magnetic resonance imaging * Considered by the investigator to be inappropriate to participate due to a history or complication of serious cardiovascular disease within 1 month of screening (for example, history of acute myocardial infarction, current acute myocardial infarction, uncontrollable heart failure, infective endocarditis requiring treatment, or acute aortic dissection, or requiring or likely to require hospitalization for severe arrhythmia during the study) * Blood glucose level \<50 or \>400 milligrams/deciliter after glycemic control * Systolic blood pressure ≥220 millimeters of mercury (mmHg) or diastolic blood pressure ≥120 mmHg after antihypertensive treatment * Sensitivity to any of the study interventions, or components thereof, or clinically significant drug or other severe allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of prohibited concomitant medications or therapies listed in the protocol for the treatment of current AIS * Participants who have previously received redasemtide * Participants who have received any investigational product within 90 days of screening Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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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.

Acute ischemic stroke

Contacts and locations

Locations

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36, Greece

  • AZ Oostende - Damiaan

    Ostend, West-Vlaanderen, 8400, Belgium

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

  • Alexandra Hospital

    Athens, Attica, 11528, Greece

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma, 74104-5437, United States

  • Augusta University

    Augusta, Georgia, 30912-0004, United States

  • Banner University of Arizona Medical Center

    Tucson, Arizona, 85724, United States

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Baylor Scott & White - Plano Brain & Spine Center

    Plano, Texas, 75093-5338, United States

  • Baylor University Medical Center - 3500 Gaston Ave

    Dallas, Texas, 75246, United States

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101199, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218, China

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106, Hungary

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Charing Cross Hospital

    London, London, City of, W6 8RF, United Kingdom

  • Chutoen General Medical Center

    Kakegawa-Shi, Shizuoka, 436-8555, Japan

  • Clinical Centre of Vojvodina

    Novi Sad, 21000, Serbia

  • Community Hospital

    Munster, Indiana, 46321-2901, United States

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 8208, Spain

  • Fairfield General Hospital - PPDS

    Bury, B19 7TD, United Kingdom

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha, Hlavní Mesto, 100 00, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Fukui Prefectural Hospital

    Fukui-shi, Hukui, 910-8526, Japan

  • Galilee Medical Center

    Nahariya, Northern District, 2210000, Israel

  • General Hospital Bor

    Bor, 19210, Serbia

  • General Hospital Cuprija

    Ćuprija, 35230, Serbia

  • General Hospital Dr. Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000, Serbia

  • General Hospital Leskovac

    Leskovac, 16000, Serbia

  • General Hospital of Thessaloniki ''G. Papanikolaou''

    Thessaloniki, 570 10, Greece

  • General Hospital of Thessaloniki ''Hippokratio''

    Thessaloniki, 546 42, Greece

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház

    Győr, 9024, Hungary

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120, Israel

  • Hanyang University Medical Center

    Seoul, 4763, South Korea

  • Health Center Uzice

    Užice, 31000, Serbia

  • Health Center Valjevo

    Valjevo, 250804, Serbia

  • Helsingin yliopistollinen sairaala

    Helsinki, Uusimaa, 290, Finland

  • Hillel Yaffe Medical Center

    Hadera, Haifa District, 38100, Israel

  • Hospital Clinico San Carlos

    Madrid, 28049, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 8221, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007, Spain

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona, 43005, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario A Coruña

    A Coruña, 15006, Spain

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Torrecardenas

    Almería, 4009, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario de Badajoz

    Badajoz, 6006, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 8907, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8025, Spain

  • Hospital for Cerebrovascular Diseases Sveti Sava

    Belgrade, 11000, Serbia

  • Houston Methodist Hospital

    Houston, Texas, 77030-2726, United States

  • Hyogo Medical University Hospital

    Nishinomiya-Shi, Hyôgo, 663-8501, Japan

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggido, 10380, South Korea

  • Intercoastal Medical Group

    Sarasota, Florida, 34239-3228, United States

  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525, Japan

  • Japanese Red Cross Takayama Hospital

    Takayama-Shi, Gifu, 506-8550, Japan

  • Keimyung University Dongsan Hospital

    Daegu, Daegu Gwang'yeogsi, 42601, South Korea

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba, 292-8535, Japan

  • King's College Hospital

    London, Surrey, SE5 9RS, United Kingdom

  • Kistarcsai Flór Ferenc Kórház

    Kistarcsa, Pest County, 2143, Hungary

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 4600, Germany

  • Kyung Hee University Hospital

    Seoul, 2447, South Korea

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Liverpool Hospital - PPDS

    Sydney, New South Wales, 2170, Australia

  • Luton and Dunstable Hospital

    Luton, Bedfordshire, LU4 0DT, United Kingdom

  • Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS

    Rochester, Minnesota, 55905-0001, United States

  • Meir Medical Center

    Kfar Saba, Central District, 44281, Israel

  • Mercyhealth Javon Bea Hospital- Riverside

    Rockford, Illinois, 61114-2300, United States

  • Military Medical Academy

    Belgrade, 11000, Serbia

  • Misyuku Hospital

    Meguro-Ku, Tokyo, 153-0051, Japan

  • Munson Healthcare

    Traverse City, Michigan, 49684, United States

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210001, China

  • National Cerebral and Cardiovascular Center

    Suita-Shi, Osaka, 564-8565, Japan

  • National Hospital Organization Beppu Medical Center

    Beppu-Shi, Oita Prefecture, 874-0011, Japan

  • National Hospital Organization Hamada Medical Center

    Hamada-Shi, Shimane, 697-8511, Japan

  • National Hospital Organization Higashihiroshima Medical Center

    Higashihiroshima-Shi, Hiroshima, 739-0041, Japan

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure-Shi, Hiroshima, 737-0023, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

  • National Hospital Organization Toyohashi Medical Center

    Toyohashi, Aichi-ken, 440-8510, Japan

  • National Hospital Organization Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575, Japan

  • National Hospital for Neurology & Neurosurgery

    London, Middlesex, WC1N 3BG, United Kingdom

  • National University Hospital- Singapore

    Singapore, 119074, Singapore

  • Naval Hospital of Athens

    Athens, Attica, 115 21, Greece

  • North Shore University Hospital-300 Community Dr

    Manhasset, New York, 11030-3816, United States

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Nuvance Health Medical Practice, PC- Neurosurgery

    Poughkeepsie, New York, 12601-3986, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240, United States

  • Omuta City Hospital

    Omuta-Shi, Fukuoka, 836-8567, Japan

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871, Japan

  • Our Lady of the Snow Social Medical Corporation St. Mary's Hospital

    Kurume-Shi, Hukuoka, 830-8543, Japan

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429, Greece

  • Prince of Wales Hospital

    Shatin, 999077, Hong Kong

  • Princess Margaret Hospital - Hong Kong

    Kwai Chung, 999077, Hong Kong

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Pécsi Tudomanyegyetem - Vasvari Pal u.

    Pécs, Baranya, 7624, Hungary

  • Queen Mary Hospital - PPDS

    Hong Kong, 999077, Hong Kong

  • Rambam Medical Center - PPDS

    Haifa, 31096, Israel

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577, Japan

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Berkshire Hospital NHS Foundation Trust

    Reading, Berkshire, RG1 5AN, United Kingdom

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052, Australia

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP, United Kingdom

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Sanyudo Hospital

    Yonezawa-Shi, Yamagata, 992-0033, Japan

  • Seisho Hospital

    Odawara-Shi, Kanagawa, 250-0001, Japan

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika

    Budapest, 1145, Hungary

  • Severance Hospital Yonsei University Health System

    Seoul, 3722, South Korea

  • Sheba Medical Center - PPDS

    Ramat Gan, 5262000, Israel

  • Shin Komonji Hospital

    Kitakyushu-Shi, Fukuoka, 800-0057, Japan

  • Shin-Kuki General Hospital

    Kuki-shi, Saitama, 346-8530, Japan

  • Shinsuma General Hospital

    Kobe, Hyôgo, 654-0048, Japan

  • Shizuoka City Shizuoka Hospital

    Aoi-Ku, Shizuoka, 420-8630, Japan

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215-5216, United States

  • Singapore General Hospital (SGH)

    Singapore, 169608, Singapore

  • Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213, Japan

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304, United States

  • Szent Damjan Gorogkatolikus Korhaz

    Kisvárda, Szabolcs-Szatmár-Bereg, 4600, Hungary

  • Tel Aviv Sourasky Medical Center - PPDS

    Tel Aviv, Tel Aviv, 64239, Israel

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Royal London Hospital

    London, Middlesex, E1 1FR, United Kingdom

  • Tominaga Hospital

    Osaka, Osaka, 556-0017, Japan

  • UZ Brussel - PIN

    Jette, Brussels Capital, 1090, Belgium

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 4103, Germany

  • University Clinical Center Nis

    Niš, 18 000, Serbia

  • University Clinical Center of Serbia - Pasterova 2 - PPDS

    Belgrade, 11000, Serbia

  • University General Hospital ''ATTIKON''

    Athens, 12462, Greece

  • University General Hospital of Alexandroupolis

    Alexandroupoli, Evros, 681 00, Greece

  • University General Hospital of Heraklion

    Heraklion, Irakleio, 710 03, Greece

  • University General Hospital of Ioannina

    Ioannina, 455 00, Greece

  • University General Hospital of Larissa

    Larissa, 411 10, Greece

  • University General Hospital of Patras

    Pátrai, Achaïa, 265 04, Greece

  • University Health-University Hospital

    San Antonio, Texas, 78229-3931, United States

  • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2

    Prague, Nové Město, 101 00, Czechia

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • ZIV Medical Center

    Safed, 13100, Israel

More trials for these conditions

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