Livmarli

(Maralixibat)

Phase 3Small molecule

Livmarli is one of 3 small molecule programs targeting Intrahepatic Cholestasis of Pregnancy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Intrahepatic Cholestasis of PregnancyNot yet recruiting

Intrahepatic CholestasisCompleted

Cholestatic Liver Disease (except ALGS, PFIC, PBC and PSC)Active, not recruiting

Intrahepatic Cholestasis of PregnancyPhase 2

Not yet recruiting

Intrahepatic CholestasisPhase 3

Completed

Cholestatic Liver Disease (except ALGS, PFIC, PBC and PSC)Phase 3

Active, not recruiting

Competition

Competitive Landscape

3 competitors in Intrahepatic Cholestasis

#DrugCompanyPhaseTrials

Actigall

AbbVie

Approved

—2

Livmarli

MMirum Pharmaceuticals, Inc.

Phase 3

5 3

Bylvay

Ipsen

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Cholestatic Liver Disease (except ALGS, PFIC, PBC and PSC)

NCT06553768

Q1 2028

Phase 2Not yet recruiting

Intrahepatic Cholestasis

NCT07389031

Q1 2029

Phase 2Not yet recruiting

Intrahepatic Cholestasis of Pregnancy

NCT07823127

Q2 2031

Recruiting

Intrahepatic Cholestasis

NCT07293897

Clinical

Trials by Indication[1]

Intrahepatic Cholestasis5 trials

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

Recruiting· Takeda logo

Takeda··NCT07293897·50 enrolled

A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Withdrawn·MMirum Pharmaceuticals, Inc.·Phase 3·NCT03353454

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

Completed·MMirum Pharmaceuticals, Inc.·Phase 3·NCT03905330·93 enrolled

Show 2 more trials

Maralixibat for Intrahepatic Cholestasis of Pregnancy

Not yet recruiting·IImperial College London·Phase 2·NCT07389031·28 enrolled

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)

Completed·MMirum Pharmaceuticals, Inc.·Phase 3·NCT04185363·84 enrolled

Cholestatic liver disease2 trials

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).

Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04729751·27 enrolled

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

Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04168385·52 enrolled

Pruritus1 trial

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

Approved for marketing·MMirum Pharmaceuticals, Inc.··NCT04530994

Overweight1 trial

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

Completed·MMirum Pharmaceuticals, Inc.·Phase 1·NCT02475317·84 enrolled

Biliary Atresia1 trial

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04524390·75 enrolled

2 more indications

Intrahepatic Cholestasis of Pregnancy1 trial

MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)

Not yet recruiting·MMirum Pharmaceuticals, Inc.·Phase 2·NCT07823127·15 enrolled

Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)1 trial

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

Active, not recruiting·MMirum Pharmaceuticals, Inc.·Phase 3·NCT06553768·90 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 29, 2021

LIVMARLI

NDA NDA214662

Apr 10, 2025

LIVMARLI

NDA NDA219485

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Maralixibat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Maralixibat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Maralixibat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219485). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Livmarli. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Mirum Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMirum Pharmaceuticals, Inc.

Patent Landscape[5]

Patent Cliff

May 26, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11260053May 26, 2031

10512657Oct 26, 2032

12350267Oct 26, 2032

11229661Oct 26, 2032

11376251Oct 26, 2032

5 more patents

12599602Feb 12, 2040

11229647Feb 12, 2040

11918578Feb 12, 2040

11497745Feb 12, 2040

12296050Oct 5, 2043

Livmarli

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Q1 2029

Q2 2031

Trials by Indication[1]

Intrahepatic Cholestasis5 trials

Cholestatic liver disease2 trials

Pruritus1 trial

Overweight1 trial

Biliary Atresia1 trial

Intrahepatic Cholestasis of Pregnancy1 trial

Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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