Could a new drug save Babies' brains after oxygen loss?

NCT ID NCT05514340

Recruiting now Disease control Sponsor: Pharmazz, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called sovateltide in newborns with brain injury from lack of oxygen at birth (hypoxic-ischemic encephalopathy). The drug aims to help the brain repair itself. About 40 full-term babies will receive either sovateltide or a placebo, along with standard cooling treatment. Researchers will track survival and disability at 6 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: sovateltide (also called PMZ-1620)
What this could lead to: If it works, this could offer a new treatment for brain injury in newborns, potentially reducing death or long-term disability.
What could go wrong: This is an early Phase 2 trial with only 40 babies, so results are uncertain. The drug may not work better than standard cooling therapy, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPOXIC-ISCHEMIC ENCEPHALOPATHY NEONATAL ASPHYXIA NEONATAL ENCEPHALOPATHY

Contacts and locations

Locations

Christian Medical College and Hospital
RECRUITING

Ludhiana, Punjab, 141008, India
Father Muller Medical College Hospital
RECRUITING

Mangalore, Karnataka, 575002, India
GSVM Medical College
NOT_YET_RECRUITING

Kanpur, Uttar Pradesh, 208002, India
Niloufer Hospital
NOT_YET_RECRUITING

Hyderabad, Telangana, 500 004, India

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