Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Hypoxic-Ischemic EncephalopathyNeonatal AsphyxiaNeonatal Encephalopathy
Interventions
DRUG

Normal Saline along with standard treatment

Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.

DRUG

Sovateltide along with standard treatment

Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.

Trial Locations (4)

141008

RECRUITING

Christian Medical College and Hospital, Ludhiana

208002

NOT_YET_RECRUITING

GSVM Medical College, Kanpur

575002

RECRUITING

Father Muller Medical College Hospital, Mangalore

500 004

NOT_YET_RECRUITING

Niloufer Hospital, Hyderabad

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmazz, Inc.

INDUSTRY

NCT05514340 - Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy | Biotech Hunter | Biotech Hunter