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

Phase 2 Recruiting 260 enrolled Mirum Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Timeline

Start: 2021-09-22
Primary completion: 2027-04
Completion: 2027-07

Publications

Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309/ajg.0000000000003559. Epub 2025 May 29. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Volixibat	Small molecule	20 mg	Oral
Subject	Volixibat	Small molecule	80 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications