Volixibat

Phase 2Small molecule

MMirum Pharmaceuticals, Inc.

Volixibat is one of 70 small molecule programs targeting Primary Biliary Cholangitis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Primary Biliary CholangitisActive, not recruiting

Sclerosing CholangitisActive, not recruiting

Intrahepatic CholestasisActive, not recruiting

Primary Biliary CholangitisPhase 2

Active, not recruiting

Sclerosing CholangitisPhase 2

Active, not recruiting

Intrahepatic CholestasisPhase 2

Active, not recruiting

Competition

Competitive Landscape

52 competitors in Sclerosing Cholangitis

#DrugCompanyPhaseTrials

Vancocin

HHikma Pharmaceuticals LLC

Approved

9 2

Actigall

AbbVie

Approved

—3

Retin-a

VValeant Pharmaceuticals

Approved

—4

Amoxil

GGlobal Antibiotics Research and Development Partnership

Mitosol

Zocor

1 7

Azulfidine

Pfizer

Phase 2

1 8

Thalomid

Bristol-Myers Squibb

Phase 2

1 9

Iqirvo

Ipsen

Phase 2

1 10

Tricor

JJagotec

Phase 2

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

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Sclerosing Cholangitis

NCT04663308

Q3 2027

Phase 2Recruiting

Primary Biliary Cholangitis

NCT05050136

Clinical

Trials by Indication[1]

Primary Biliary Cholangitis1 trial

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Recruiting·MMirum Pharmaceuticals, Inc.·Phase 2·NCT05050136·260 enrolled

Sclerosing Cholangitis1 trial

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Active, not recruiting·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04663308·182 enrolled

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

Intrahepatic Cholestasis1 trial

A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

Terminated·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04718961·4 enrolled

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Volixibat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Volixibat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Volixibat. EMBL-EBI & Wellcome Sanger Institute.
[4]
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 2[1]
Company: MMirum Pharmaceuticals, Inc.

Volixibat

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Primary Biliary Cholangitis1 trial

Sclerosing Cholangitis1 trial

Overweight1 trial

Intrahepatic Cholestasis1 trial

References

Drug Info

Quick Facts

Related News