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Volixibat

DRUG6 trials

Sponsors

Mirum Pharmaceuticals Inc., Mirum Pharmaceuticals, Inc.

Conditions

Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC).Healthy VolunteersIntrahepatic Cholestasis of PregnancyPBCPrimary Biliary CholangitisPrimary Sclerosing CholangitisPruritus associated with Primary Sclerosing Cholangitis (PSC)

Phase 1

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
CompletedNCT02475317
Mirum Pharmaceuticals, Inc.Healthy Volunteers
Start: 2015-06-01End: 2015-12-01Updated: 2019-04-04

Phase 2

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 recruitingNCT04663308
Mirum Pharmaceuticals, Inc.Primary Sclerosing Cholangitis
Start: 2020-12-18End: 2027-04-01Updated: 2026-02-04
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
TerminatedNCT04718961
Mirum Pharmaceuticals, Inc.Intrahepatic Cholestasis of Pregnancy
Start: 2021-01-04End: 2022-12-07Updated: 2024-08-06
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
RecruitingNCT05050136
Mirum Pharmaceuticals, Inc.PBC, Primary Biliary Cholangitis
Start: 2021-09-22End: 2027-07-01Target: 260Updated: 2026-04-02
A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Active, not recruitingCTIS2023-505764-11-00
Mirum Pharmaceuticals Inc.Pruritus associated with Primary Sclerosing Cholangitis (PSC)
Start: 2022-06-10Target: 105Updated: 2025-11-24
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 (VANTAGE)
RecruitingCTIS2023-504660-41-00
Mirum Pharmaceuticals Inc.Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC).
Start: 2022-07-11Target: 84Updated: 2025-11-12

Related Papers

Efficacy, Safety and Tolerability of Volixibat, an <scp>IBAT</scp> Inhibitor, in Patients With Intrahepatic Cholestasis of Pregnancy
Liver International2026-01-28
Breaking Grounds: A Comprehensive Analysis of Cutting-Edge Treatments for Primary Biliary Cirrhosis/Primary Biliary Cholangitis With Futuristic Treatments.
2025-02-24