VivoSeq
Gastroenterology

Cholestatic Liver Disease

10

Pipeline Programs↗

4

Active Trials↗

6

Companies Involved↗

Cholestatic liver disease is an early-stage landscape with 10 programs across 6 companies. The most active players are Zydus Therapeutics Inc., Mirum Pharmaceuticals, Inc., AbbVie. 1 therapy is approved with 2 more in late-stage development.

Intelligence

Pipeline Metrics

Competitive Density

38/100

Pipeline Velocity

11/100

Mech. Concentration

33/100

Completion Rate

100/100

Attrition Rate

0/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved
Phase 3
Phase 2
Phase 1
Preclinical

Key Players

Top Companies Companies ranked by the number of pipeline programs they run for this disease.

Z

Zydus Therapeutics Inc.

1 program

Phase 1M

Mirum Pharmaceuticals, Inc.

2 programs

Phase 2AbbVie logo

AbbVie

1 program

Phase 2Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.

1 program

Phase 3Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals

1 program

ApprovedF

Fresenius Kabi Oncology Ltd.

1 program

Preclinical

Pipeline

Programs by Phase

Analysis

Trial Status

14

clinical trials

Completed9 · 64%
Recruiting4 · 29%
Unknown status1 · 7%

Clinical Trials

Trial Activity

14 trials

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Recruiting·MMirum Pharmaceuticals, Inc.·Phase 3·NCT06553768·90 enrolled
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Recruiting·ZZydus Therapeutics Inc.·Phase 1·NCT06825559·6 enrolled
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Recruiting·ZZydus Therapeutics Inc.·Phase 1·NCT05045482·30 enrolled
Accelerated Correction of Vitamin D Deficiency in Cholestatic Children: a Comparative Trial of Vitamin D2 Monotherapy vs Combination Therapy With Calcitriol
Recruiting·CChulalongkorn University·Approved·NCT07670611·54 enrolled
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT01903460·20 enrolled
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
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00007033·25 enrolled
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT02117713·34 enrolled
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT02057718·33 enrolled
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
Completed·ZZydus Therapeutics Inc.·Phase 1·NCT04469920·98 enrolled
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT02047318·19 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
Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Completed·BBeijing Trendful Kangjian Medical Information Consulting Limited Company·Phase 3·NCT01829698·199 enrolled
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
Unknown status·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004315·20 enrolled

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)