Seladelpar 10 mg

DRUG3 trials

Sponsors

Gilead Sciences

Conditions

Primary Biliary Cholangitis

Phase 3

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

CompletedNCT03602560

Gilead SciencesPrimary Biliary Cholangitis

Start: 2018-10-01End: 2020-02-16Updated: 2022-08-02

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

CompletedNCT04620733

Gilead SciencesPrimary Biliary Cholangitis

Start: 2021-04-21End: 2023-08-11Updated: 2024-09-05

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

CompletedNCT06060665

Gilead SciencesPrimary Biliary Cholangitis

Start: 2023-09-05End: 2026-05-06Updated: 2026-06-04

Related Papers

Seladelpar Improved Itch, Itch‐Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3 <scp>RESPONSE</scp> Trial

Alimentary Pharmacology & Therapeutics2026-04-03

EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS PREVIOUSLY TREATED WITH FIBRATES OR OBETICHOLIC ACID

Annals of Hepatology2025-09-01

EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND COMPENSATED CIRRHOSIS IN THE PHASE 3 PLACEBO-CONTROLLED RESPONSE TRIAL

Annals of Hepatology2025-09-01

OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY

Annals of Hepatology2024-12-011 citations

A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis

New England Journal of Medicine2024-02-21185 citations