Wednesday, July 8, 2026

Drug profile · INN

maralixibat chloride

maralixibat chloride (LIVMARLI) is a ileal bile acid transporter inhibitor. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Alimentary tract and metabolism (A05) A05AX04
US status approved
Patents linked 4
Pipeline programs 9
News articles 0
Drug details — maralixibat chloride
US status
approved
Class
Alimentary tract and metabolism (A05)
Route
ORAL
Patents
4
Programs
9
Data quality
0.89

Quick answer

maralixibat chloride (LIVMARLI) is a ileal bile acid transporter inhibitor. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN maralixibat chloride
Brand LIVMARLI
Mechanism Ileal bile acid transporter inhibitor
Target Ileal sodium/bile acid cotransporter
Therapeutic class Alimentary tract and metabolism (A05)
Route ORAL
Formulation SOLUTION
ATC code A05AX04

Mechanism of action

Ileal bile acid transporter inhibitor

Primary target: Ileal sodium/bile acid cotransporter

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. MRX-802 Phase 3 · Anaxis Pharma · Cholestatic Pruritus
  2. Maralixibat Phase 3 · Mirum Pharmaceuticals International · Progressive Familial Intrahepatic Cholestasis (PFIC)
  3. Maralixibat Phase 3 · Mirum Pharmaceuticals International · Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
  4. Maralixibat Phase 2 · Mirum Pharmaceuticals International · Biliary Atresia
  5. Maralixibat Phase 2 · Mirum Pharmaceuticals International · Cholestatic Liver Disease
  6. Maralixibat Phase 2 · Mirum Pharmaceuticals International · Intrahepatic Cholestasis of Pregnancy
  7. Maralixibat Phase 2 · Mirum Pharmaceuticals International · Progressive Familial Intrahepatic Cholestasis
  8. Livmarli 9.5 mg/mL oral solution Approved · Anaxis Pharma · Progressive Familial Intrahepatic Cholestasis, Alagille synd

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. US 12296050

    Pharmaceutical compositions comprising maralixibat and uses thereof

    Expires Mon May 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11918578

    Methods for treating cholestasis

    Expires Mon Feb 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11497745

    Methods for treating cholestasis

    Expires Mon Nov 10 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11229647

    Methods for treating cholestasis

    Expires Mon Jan 20 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is maralixibat chloride?

maralixibat chloride (LIVMARLI) is a ileal bile acid transporter inhibitor. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for maralixibat chloride?

LIVMARLI is a marketed brand name for maralixibat chloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of maralixibat chloride?

maralixibat chloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.