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Maralixibat · Livmarli, LUM001

Small molecule · Inhibitor of ileal bile acid transporter (IBAT) (SLC10A2) · developed by Mirum

Approved FDA, Sep 2021
MIRM Developer
5 Registered trials

What is Maralixibat?

Maralixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT) that decreases bile acid reabsorption from the terminal ileum.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Livmarli, LUM001, LUM-001 CATION, TAK-625, Formerly LUM001, SHP625
Drug type
Small molecule
Targets
ileal bile acid transporter (IBAT) (SLC10A2)
Mechanism
Inhibitor of ileal bile acid transporter (IBAT) (SLC10A2)
Pathways
bile acid reabsorption
Therapy area
Gastroenterology
Developer
Mirum (MIRM)
FDA status
Approved as Livmarli (September 29, 2021), NDA214662 · FDA label
UNII
UYB6UOF69L

✅ FDA-approved uses

From the indications section of the FDA label (version of Apr 10, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07290257 Phase 4 Alagille Syndrome Recruiting MIRM
NCT06553768 Phase 3 Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) Active not recruiting MIRM
NCT02061540 Phase 2 Primary Sclerosing Cholangitis (PSC) Completed MIRM
NCT02057718 Phase 2 Progressive Familial Intrahepatic Cholestasis (PFIC) Completed MIRM
NCT06193928 N/A Alagille Syndrome Recruiting MIRM

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Alagille SyndromeCholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)Progressive Familial Intrahepatic CholestasisPrimary Sclerosing Cholangitis (PSC)Progressive Familial Intrahepatic Cholestasis (PFIC)

Other drugs acting on SLC10A2

More from Mirum

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the MIRM page.

Follow MIRM, the company behind Maralixibat

See MIRM's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.