New drug shows promise for babies with rare liver disorders

NCT ID NCT04729751

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety of a drug called maralixibat in 27 infants under 12 months old with Alagille syndrome or progressive familial intrahepatic cholestasis (PFIC), two rare liver diseases that cause bile buildup. The drug is given as an oral solution and aims to reduce bile acids and improve liver function. The main goal was to see if it is safe and tolerable in this young age group.

What this could mean

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

Active substance

maralixibat (oral solution)

What this could lead to

If it works, this could offer a way to manage cholestatic liver disease in infants, reducing itching and bile acid buildup without immediate surgery.

What could go wrong

This is a small, early-phase study focused on safety, not proof of effectiveness. The drug may not work for all types of these rare diseases, and side effects are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Alagille syndrome bile duct disorder biliary tract disorder Cholestasis, progressive familial intrahepatic 1 liver disorder progressive familial intrahepatic cholestasis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Children Hospital LA

    Los Angeles, California, 90027, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Consultorio de Joshue David Covarrubias Esquer

    Zapopan, 45050, Mexico

  • Hopital Necker

    Paris, France

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre, France

  • Instytut Pomnik-Centrum Zdrowia Dziecka

    Warsaw, Poland

  • King's College Hospital

    London, United Kingdom

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Ochsner Hospital for Children

    New Orleans, Louisiana, 70121, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Sociedade Beneficente de Senhoras - Hospital Sírio-Libanês

    São Paulo, 01308-000, Brazil

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California - San Francisco

    San Francisco, California, 94158, United States