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NCT03301506Phase 3ACTIVE NOT RECRUITING

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Study Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Conditions
Primary Biliary Cirrhosis
Interventions / Drugs
Seladelpar 5 mg CapsuleSeladelpar 10 mg Capsule
View on ClinicalTrials.gov ↗
Sponsor
GILD
Gilead Sciences
Antiviral
F28/100
Study Details
Enrollment500 participants
Primary Completion—
Lead SponsorGilead Sciences
Data Retrieved2026-04-11 02:55:27.112490+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 500 participants
Sponsor Catalyst Profile

Gilead Sciences (GILD) is the sponsoring company for this trial. BiotechSign currently grades this company F (28/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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