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

StatusRecruiting
PhasePhase 4
Started2024-01-08
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 31, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
This is a prospective, multicenter, randomized, double-blind, parallel, phase IV study designed to evaluate the safety and efficacy of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.

Amendment record

Amended 5 times since 2023-07-18; most recent filed 2025-12-26. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-12-26
Amendment Study Status v5
2025-05-09
Amendment Study Status v4
2024-04-04
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
2023-10-16
Amendment Study Status, Outcome Measures v2
2023-09-25
Amendment Recruiting→Not Yet Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v1
2023-07-18
Original filing
Trial Details
NCT Number NCT05955326
Lead Sponsor Pharmazz, Inc.
Conditions Acute Cerebral Ischemia
Enrollment 160 participants
Start Date 2024-01-08
Primary Completion 2026-02 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-31