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Sovateltide treatment for acute ischemic stroke

A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.

PHASE3 · Pharmazz, Inc. · NCT05691244

This test will try sovateltide in adults aged 18–80 who had an ischemic stroke within 24 hours to see if it helps improve recovery.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment514 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorPharmazz, Inc. (industry)
Locations42 sites (Tuscon, Arizona and 41 other locations)
Trial IDNCT05691244 on ClinicalTrials.gov

What this trial studies

This is a phase 3 interventional trial that compares sovateltide with normal saline in adults who have had an acute ischemic stroke. Eligible participants are adults 18–80 years old with imaging-confirmed ischemic stroke presenting within 24 hours and an NIHSS score between 8 and less than 20. Outcomes reported in earlier trials include changes in NIHSS, modified Rankin Scale, and Barthel Index, and prior human data include a small phase I safety study and phase II/III results from India. The trial is being conducted at several U.S. hospital sites including the University of Arizona College of Medicine and regional medical centers in California.

Who should consider this trial

Good fit: Adults aged 18–80 with a CT/MRI-confirmed ischemic stroke who present within 24 hours of symptom onset and have an NIHSS score of ≥8 and <20 (and no intracranial hemorrhage) are the intended candidates.

Not a fit: Patients with hemorrhagic stroke, those presenting more than 24 hours after symptom onset, or those with NIHSS or pre-stroke disability outside the trial's eligibility range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, sovateltide could improve neurological recovery and daily functioning after acute ischemic stroke.

How similar studies have performed: Early human data include a phase I safety study and phase II/III results from India that reported safety and improvements on NIHSS, mRS, and Barthel Index for sovateltide.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tuscon, Arizona and 41 other locations

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 →

Conditions: Acute Ischemic Stroke, Cerebral Stroke, Endothelin B Receptors

Last reviewed 2026-05-15 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.