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maralixibat

Generic: MARALIXIBAT CHLORIDE·Brand: LIVMARLI, Livmarli

maralixibat: developed by 1 company · 4 clinical trials tracked.

maralixibat evidence translation

What we can confirm

What it means

Source-backed records connect maralixibat to MIRM; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could maralixibat → MIRM affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 1 study sponsors

Related indications

Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC); Progressive Familial Intrahepatic Cholestasis; Progressive Familial Intrahepatic Cholestasis (PFIC)Alagille Syndrome
Development Pipeline (2)
CompanyPhase
Mirum Pharmaceuticals, Inc. (MIRM)
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC); …
Phase 4
Mirum Pharmaceuticals, Inc. (MIRM)
Alagille Syndrome
Approved
Clinical Trials (4)

A Cohort Study to Investigate the Risk of Liver Disorder of Livmarli Oral Solution in Patients With Japan Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) Registered in the Comprehensive and Informative Registry System for Childhood Liver Disease (CIRCLe)

NCT07293897·TAK
Recruiting

Primary endpoint: Percentage of Participants with ALGS who Experience Liver Disorder Evaluated with Outcome Definition 1 (Side Effects)

Observational50 targetStarted 2026-01Completion 2031-061 site · JapanTakeda

Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants With Cholestatic Pruritus

NCT06553768·Phase 3·MIRM
Active, not recruiting

Primary endpoint: Mean change in the ItchRO(Obs) severity score

InterventionalRandomizedquadruple90 targetStarted 2024-10Completion 2027-0224 sites · Brazil, Canada, France, Germany…Mirum Pharmaceuticals, Inc.

Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome

NCT04729751·Phase 2·MIRM
Completed

Primary endpoint: Frequency of Treatment-emergent Adverse Events [TEAEs]

Interventionalopen27 enrolledStarted 2021-09Completion 2024-1214 sites · Belgium, Brazil, France, Mexico…Mirum Pharmaceuticals, Inc.

An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

NCT04185363·Phase 3·MIRM
Completed

Primary endpoint: Mean Change From Baseline Over Time in the Average Morning ItchRO(Obs) Severity Score

Interventionalopen84 enrolledStarted 2020-01Completion 2025-0428 sites · Argentina, Austria, Belgium, Brazil…Mirum Pharmaceuticals, Inc.

Frequently asked questions

Who is developing maralixibat?

maralixibat is being developed by Mirum Pharmaceuticals, Inc..

How many clinical trials involve maralixibat?

BioSniper tracks 4 clinical trials involving maralixibat.