Monday, October 20, 2025

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

 

Your competent? doctor has been working on peptides for over a decade, right? Oh NO, INCOMPETENCE REIGNED AND NOTHING WAS DONE, CORRECT?

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  • Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial

     November 2024

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

    ClinicalTrials.gov IDNCT05691244
    SponsorPharmazz, Inc.
    Information Provided byAnil Gulati, MD, PhD
    Study Start (Actual)2025-07-24
    Primary Completion (Estimated) 2026-09
    Study Completion (Estimated)2026-11
    Enrollment (Estimated)514
    Study TypeInterventional
    Last Update Posted2025-10-16

    Study Overview

    Brief 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.

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