Volixibat

Phase 2Small molecule

MMirum Pharmaceuticals, Inc.

Volixibat is one of 11 small molecule programs targeting Primary Sclerosing Cholangitis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Primary Sclerosing CholangitisActive, not recruiting

Primary Biliary CholangitisActive, not recruiting

Primary Sclerosing CholangitisPhase 2

Active, not recruiting

Primary Biliary CholangitisPhase 2

Active, not recruiting

Competition

Competitive Landscape

10 competitors in Primary Biliary Cholangitis

#DrugCompanyPhaseTrials

Cellcept

Roche

Approved

1 2

Ocaliva

IIntercept Pharmaceuticals

Approved

4 3

Iqirvo

Ipsen

Phase 3

3 4

Tricor

JJagotec

Phase 3

4 5

Lipaglyn

ZZydus Therapeutics Inc.

Phase 3

5 6

Selincro

IIndivior Inc.

Phase 2

1 7

CS0159

CCascade Pharmaceuticals, Inc

Phase 3

2 8

Seladelpar

Gilead

Phase 3

6 9

Volixibat

MMirum Pharmaceuticals, Inc.

Phase 2

1 10

Ocaliva

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

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

Timeline

Expected Milestones

Q1 2028

Phase 2Active, not recruiting

Primary Sclerosing Cholangitis

NCT04663308

Q4 2028

Phase 2Active, not recruiting

Primary Biliary Cholangitis

NCT05050136

Clinical

Trials by Indication[1]

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

Primary Sclerosing Cholangitis1 trial

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Sclerosing Cholangitis

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

Primary Biliary Cholangitis1 trial

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis

Active, not recruiting·MMirum Pharmaceuticals, Inc.·Phase 2·NCT05050136·333 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

Q1 2028

Q4 2028

Trials by Indication[1]

Overweight1 trial

Intrahepatic Cholestasis1 trial

Primary Sclerosing Cholangitis1 trial

Primary Biliary Cholangitis1 trial

References

Drug Info

Quick Facts

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