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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2025

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At a glance

  • Drugs Sovateltide (Primary)
  • Indications Ischaemic stroke
  • Focus Registrational; Therapeutic Use
  • Acronyms RESPECT-ETB
  • Sponsors Pharmazz

Most Recent Events

  • 29 Jul 2025 According to a Pharmazz media release, company announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke. Dr. Thomas Devlin, MD, PhD, FSVIN is the principal investigator of the Phase 3 trial. The trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK.
  • 20 Jul 2025 Planned initiation date (estimated date of first patient enrollment) changed from 1 Jul 2025 to 26 Jul 2025.
  • 20 Jul 2025 Status changed from not yet recruiting to recruiting.

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