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Recruiting Phase 3 Interventional

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

ClinicalTrials.gov ID: NCT05691244

Public ClinicalTrials.gov record NCT05691244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 6:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

Study identification

NCT ID
NCT05691244
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pharmazz, Inc.
Industry
Enrollment
514 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 23, 2025
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026
Last update posted
Jun 23, 2026

2025 – 2026

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
The University of Arizona - College of Medicine Tucson Arizona 85719 Recruiting
Mercy Medical Group Carmichael California 95608 Recruiting
St. John's Regional Medical Center Oxnard California 93030 Recruiting
Sarasota Memorial Hospital Sarasota Florida 34239 Recruiting
Wellstar Kennestone Hospital Marietta Georgia 30060 Recruiting
SSM Health Neurosciences Bridgeton Missouri 63044 Recruiting
Hackensack University Medical Center at Paramus Paramus New Jersey 07652 Recruiting
Guilford Neurologic Associates Inc Greensboro North Carolina 27401 Recruiting
OSU Wexner Medical Center Columbus Ohio 43210 Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania 17033 Recruiting
UPMC Presbyterian Hospital Pittsburgh Pennsylvania 15213 Recruiting
CHI Memorial Neuroscience Institute Chattanooga Tennessee 37404 Recruiting
Houston Medical Neurological Institute Houston Texas 77030 Recruiting
Memorial Hermann Hospital Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05691244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 23, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05691244 live on ClinicalTrials.gov.

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