Drugs / Maralixibat
Drug research

Maralixibat

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as Formerly LUM001 and SHP625; Formerly LUM001, SHP625

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

TrialSponsorPhaseStatusPrimary completion
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).NCT04729751MIRMPhase 2Completed2024-12-17Actual
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)NCT06553768MIRMPhase 3Active not recruiting2026-10Estimated
MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat StudyNCT04168385MIRMPhase 2Completed2024-09-04Actual
Evaluation of Maralixibat in Biliary Atresia Response Post-KasaiNCT04524390MIRMPhase 2Completed2023-11-07Actual
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)NCT03905330MIRMPhase 3Completed2022-09-01Actual
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)NCT04185363MIRMPhase 3Completed2025-04-23Actual

Regulatory dates and decisions

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