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RECRUITING Phase 3

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

NCT05691244 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Drug: Normal Saline
  • DRUG Sovateltide

Study Locations (20)

California

  • Mercy Medical Group — Carmichael
  • St. John's Regional Medical Center — Oxnard

Texas

  • Houston Medical Neurological Institute — Houston
  • Memorial Hermann Hospital — Houston

Other

  • Universitätsklinikum Essen AöR — Essen
  • Universitätsklinikum Schleswig-Holstein AöR — Lübeck

Barcelona

  • Hospital Germans Trias i Pujol — Badalona
  • Hospital Universitari Vall d'Hebron — Barcelona

Arizona

  • The University of Arizona - College of Medicine — Tuscon

Missouri

  • SSM Health Neurosciences — Bridgeton

Ohio

  • OSU Wexner Medical Center — Columbus

Pennsylvania

  • UPMC Presbyterian Hospital — Pittsburgh

Trial Details

FieldValue
Enrollment Target 514 participants
Start Date 2025-07-24
Est. Completion 2026-11
Phase Phase 3

Sponsor

Pharmazz

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05691244

The ClinicalTrials.gov registry entry for NCT05691244 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmazz, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions — of which Drug: Normal Saline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05691244 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05691244 about?

NCT05691244 is a clinical study titled "Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke". 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 th...

What is the current status of trial NCT05691244?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2025-07-24. Estimated completion is 2026-11.

What conditions does trial NCT05691244 study?

This clinical trial studies the following conditions: Acute Ischemic Stroke, Cerebral Stroke. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05691244?

The interventions under investigation include: Drug: Normal Saline (DRUG), Sovateltide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05691244?

This trial is sponsored by Pharmazz, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05691244 being conducted?

This trial has 20 study locations across Arizona, California, Missouri, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial