Linerixibat

DRUG7 trials

Sponsors

GlaxoSmithKline

Conditions

CholestasisPruritus

Phase 1

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

CompletedNCT05133830

GlaxoSmithKlinePruritus

Start: 2021-11-23End: 2022-05-31Updated: 2022-11-08

Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls

CompletedNCT05393076

GlaxoSmithKlinePruritus

Start: 2022-07-19End: 2022-12-06Updated: 2023-01-18

Food Effect Study of Linerixibat Tablets in Healthy Adult Participants

CompletedNCT05435170

GlaxoSmithKlinePruritus

Start: 2022-08-11End: 2022-10-10Updated: 2022-11-29

Phase 3

Linerixibat Long-term Safety, and Tolerability Study

Active, not recruitingNCT04167358

GlaxoSmithKlineCholestasis

Start: 2020-07-14End: 2026-09-30Updated: 2026-06-22

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

CompletedNCT04950127

GlaxoSmithKlinePruritus

Start: 2021-08-27End: 2024-12-20Updated: 2026-07-22

J-LINX: Japan LINerixibat eXtension Study

Not yet recruitingNCT07860710

GlaxoSmithKlinePruritus

Start: 2026-10-09End: 2028-10-23Target: 40Updated: 2026-10-06

Unknown Phase

Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

GlaxoSmithKlinePruritus

Updated: 2025-02-27

Related Papers

Meaningful Improvement Thresholds for Pruritus and Sleep Disturbance in PBC Using the Worst Itch and Sleep Interference Numerical Rating Scales

Advances in Therapy2026-08-29

Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.

2025-10-281 citations

Breaking Grounds: A Comprehensive Analysis of Cutting-Edge Treatments for Primary Biliary Cirrhosis/Primary Biliary Cholangitis With Futuristic Treatments.

2025-02-24

Pervasive role of pruritus in impaired quality of life in patients with primary biliary cholangitis: Data from the GLIMMER study

Hepatology Communications2025-02-196 citations

Analysis of <scp>C4</scp> Concentrations to Predict Impact of Patient‐Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat

CPT Pharmacometrics & Systems Pharmacology2025-02-132 citations

Population Dose–Response‐Time Analysis of Itch Reduction and Patient‐Reported Tolerability Supports Phase III Dose Selection for Linerixibat

Clinical Pharmacology & Therapeutics2023-11-1310 citations