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Maralixibat

DRUG11 trials

Sponsors

Mirum Pharmaceuticals, Inc., Takeda, Imperial College London

Conditions

Alagille SyndromeAlagille Syndrome (ALGS)Biliary AtresiaCholestatic Liver DiseaseCholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)Healthy VolunteersIntrahepatic Cholestasis of PregnancyProgressive Familial Intrahepatic Cholestasis

Phase 1

Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion
CompletedNCT02475317
Mirum Pharmaceuticals, Inc.Healthy Volunteers
Start: 2015-06-01End: 2015-12-01Updated: 2019-04-04

Phase 2

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study
CompletedNCT04168385
Mirum Pharmaceuticals, Inc.Cholestatic Liver Disease
Start: 2020-01-16End: 2024-09-04Updated: 2025-12-08
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
CompletedNCT04524390
Mirum Pharmaceuticals, Inc.Biliary Atresia
Start: 2021-07-08End: 2024-02-07Updated: 2025-03-19
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
CompletedNCT04729751
Mirum Pharmaceuticals, Inc.Alagille Syndrome, Cholestatic Liver Disease, Progressive Familial Intrahepatic Cholestasis
Start: 2021-09-09End: 2024-12-17Updated: 2025-02-06
Maralixibat for Intrahepatic Cholestasis of Pregnancy
Not yet recruitingNCT07389031
Imperial College LondonIntrahepatic Cholestasis of Pregnancy
Start: 2026-04-01End: 2028-03-31Target: 28Updated: 2026-02-05

Phase 3

A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
WithdrawnNCT03353454
Mirum Pharmaceuticals, Inc.Progressive Familial Intrahepatic Cholestasis (PFIC)
Start: 2018-10-25End: 2020-06-15Updated: 2019-03-18
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
CompletedNCT03905330
Mirum Pharmaceuticals, Inc.Progressive Familial Intrahepatic Cholestasis (PFIC)
Start: 2019-07-09End: 2022-09-01Updated: 2023-12-11
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
CompletedNCT04185363
Mirum Pharmaceuticals, Inc.Progressive Familial Intrahepatic Cholestasis (PFIC)
Start: 2020-01-08End: 2025-04-23Updated: 2025-06-29
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Active, not recruitingNCT06553768
Mirum Pharmaceuticals, Inc.Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Start: 2024-10-14End: 2027-02-01Target: 90Updated: 2026-03-30

Unknown Phase

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
NCT04530994
Mirum Pharmaceuticals, Inc.Alagille Syndrome
Updated: 2021-10-20
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
RecruitingNCT07293897
TakedaAlagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
Start: 2026-01-13End: 2031-06-30Target: 50Updated: 2026-02-20

Related Papers

Maralixibat in progressive familial intrahepatic cholestasis (MARCH-PFIC): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
2024-05-0626 citations