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

NCT ID NCT05514340

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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