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Evaluating redasemtide for treating acute ischemic stroke in adults

A Phase 2b, Multinational, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Redasemtide (S-005151) Compared With Placebo in Adult Participants With Acute Ischemic Stroke Who Are Not Eligible for Tissue Pasminogen Activator or Thrombectomy

Phase 2 Interventional Shionogi Inc. · NCT05953480

This study is testing a new treatment called redasemtide to see if it can help adults who have had an acute ischemic stroke and aren't able to receive standard therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment627 (estimated)
Ages18 Years and up
SexAll
SponsorShionogi Inc. Industry-sponsored
Locations166 sites (Tucson, Arizona and 165 other locations)
Trial IDNCT05953480 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of redasemtide, a novel treatment, in adult participants suffering from acute ischemic stroke. Participants will be randomly assigned to receive either redasemtide or a placebo within 25 hours of stroke onset. The study will focus on individuals who are not candidates for standard recanalization therapies, ensuring a specific patient population is targeted. The primary outcome will be measured using the NIHSS score to evaluate neurological function.

Who should consider this trial

Good fit: Ideal candidates are adults with acute ischemic stroke who can start treatment within 25 hours of symptom onset and have a baseline NIHSS score between 8 and 22.

Not a fit: Patients who are eligible for recanalization therapies or have significant comorbid neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with acute ischemic stroke who are ineligible for existing interventions.

How similar studies have performed: While the approach of using redasemtide is novel, similar studies targeting acute ischemic stroke have shown varying degrees of success with different therapeutic agents.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Able to initiate study intervention within 25 hours of stroke onset
* Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke.
* Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an increase or decrease of ≥ 4 points within ≥ 1 hour to ≤ 3 hours between screening and baseline assessment of NIHSS score.
* 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.

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 CT or MRI
* 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.

Where this trial is running

Tucson, Arizona and 165 other locations

+116 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic StrokeRedasemtideS-005151Plasminogen activatorThrombectomy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.