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Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

StatusRecruiting
PhasePhase 2
Started2023-09-06
View on ClinicalTrials.gov ↗
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.

Amendment record

Amended 9 times since 2022-08-22; 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 2026-08-31.

2025-12-26
Amendment Study Status, Oversight v9
2025-05-09
Amendment Study Status, Oversight v8
2023-10-16
Amendment Study Status v7
2023-07-07
Amendment Study Status, Contacts/Locations v6
2023-07-06
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
2023-06-19
Amendment Study Status v4
2023-03-06
Amendment Study Status v3
2023-01-11
Amendment Study Status v2
2022-08-24
Amendment Study Identification, Study Status v1
2022-08-22
Original filing
Trial Details
NCT Number NCT05514340
Lead Sponsor Pharmazz, Inc.
Conditions Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
Enrollment 40 participants
Start Date 2023-09-06
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-31