New drug TAK-625 shows promise for rare liver disease in kids

NCT ID NCT05543174

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 study tested TAK-625 (maralixibat) in 7 Japanese children with Alagille syndrome, a rare genetic liver disorder. The goal was to see if the drug reduces bile acid levels and itching, and to find the best dose. Participants took the drug daily for up to 34 months, with regular clinic visits to monitor safety and effectiveness.

What this could mean

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

Active substance
TAK-625 (maralixibat chloride)
What this could lead to
If it works, this could lead to a treatment that reduces bile acid buildup and itching in children with Alagille syndrome, improving their daily life.
What could go wrong
This is a very small, completed study with only 7 participants, so results may not apply to everyone. The drug may cause side effects or not work as well in larger groups.

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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, Japan

  • Kindai University Nara Hospital

    Ikoma, Nara, Japan

  • Kyoto University Hospital

    Kyoto, Japan

  • Miyagi Children's Hospital

    Sendai, Miyagi, Japan

  • Osaka University Hospital

    Suita, Osaka, Japan

  • Saitama Prefectural Children's Medical Center

    Saitama, Japan

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, Japan

  • Yokohamashi Tobu Hospital

    Yokohama, Kanagawa, Japan

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