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Clinical trialNCT05514340RecruitingPhase 2Interventional

Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

SponsorPharmazz, Inc.Enrollment40Hypoxic-Ischemic EncephalopathyNeonatal AsphyxiaNeonatal Encephalopathy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered 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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

India
  • Father Muller Medical College Hospital

    Mangalore, Karnataka, India

    Recruiting
  • Christian Medical College and Hospital

    Ludhiana, Punjab, India

    Recruiting
  • Niloufer Hospital

    Hyderabad, Telangana, India

    Not, yet, recruiting
  • Gsvm Medical College

    Kanpur, Uttar Pradesh, India

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Normal Saline along with standard treatmentSovateltide along with standard treatment
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Sept 2023
Primary completion
30 Nov 2026
Completion
31 Dec 2026
Last update posted
31 Dec 2025
Registered enrollment
40
Registry id
NCT05514340
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.