Evaluating Sovateltide for treating brain injury in newborns
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates
Run by Pharmazz, Inc. · NCT05514340 · Data updated 2026-11-12
This study is testing a new treatment called Sovateltide to see if it can help newborns with brain injuries caused by lack of oxygen during birth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Pharmazz, Inc. Industry-sponsored |
| Locations | 4 sites (Mangalore, Karnataka and 3 other locations) |
| Status | Recruiting |
| Started | September 6, 2023 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT05514340 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates with a gestational age of 36 weeks or more who are receiving supportive management for perinatal asphyxia.
✕Probably not a fit
Patients with gestational age less than 36 weeks or those with genetic conditions affecting neuronal development may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial assesses the safety and efficacy of Sovateltide, a novel treatment for hypoxic-ischemic encephalopathy (HIE) in neonates. HIE is a serious condition resulting from oxygen deprivation during birth, leading to significant neurological damage. The trial compares Sovateltide combined with standard supportive care against normal saline with standard care. The goal is to determine if Sovateltide can improve outcomes for infants suffering from this life-threatening condition, particularly since current treatments have limited success.
Why it matters
Potential benefit: If successful, this treatment could significantly improve neurological outcomes for infants affected by hypoxic-ischemic encephalopathy.
How similar studies have gone: While therapeutic hypothermia is the current standard of care, there are no pharmacotherapies proven effective for HIE, making this approach novel and potentially groundbreaking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Either sex with ≥ 36 weeks of gestational age 2. Receiving supportive management for perinatal asphyxia 3. Perinatal depression, based on at least one of the following: * Apgar score of \<5 at 10 minutes * Need for resuscitation (chest compressions or mechanical ventilation) at birth * pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth * Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth. 4. Informed consent by one of the parents or a legal representative Exclusion Criteria: 1. Gestational age \<36 weeks 2. Admitted to hospital 12-hours after birth 3. A genetic or congenital condition that affects neuronal development 4. TORCH infection 5. Neonatal sepsis 6. Complex congenital heart disease 7. Severe dysmorphic feature 8. Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
Where it's running
-
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
Study contacts
- Study coordinator: Manish S Lavhale
- Email: manish.lavhale@pharmazz.com
- Phone: +91 9873847397
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.