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ClinicalTrials.gov 4 recruiting now official registry

Primary Biliary Cholangitis clinical trials

Every US clinical trial registered for Primary Biliary Cholangitis — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

9 US clinical trials · 4 currently recruiting

The research picture

Primary Biliary Cholangitis has 9 registered US clinical trials, 4 of them open to new participants right now — about 44% of the total.

4
recruiting participants now
44%
of trials open to enrollment
5
in Phase 3–4 (later-stage)
3
top sponsor: Gilead Sciences

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING 424 participants

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Ipsen

NCT06447168

RECRUITING Phase 3 318 participants

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Gilead Sciences

NCT06051617

RECRUITING Phase 2 260 participants

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

Mirum Pharmaceuticals

NCT05050136

RECRUITING Phase 3 150 participants

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Zydus Therapeutics

NCT06427395

ACTIVE NOT RECRUITING Phase 3 90 participants

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

Gilead Sciences

NCT06060665

ACTIVE NOT RECRUITING Phase 3 69 participants

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Ipsen

NCT06383403

ACTIVE NOT RECRUITING Phase 2 46 participants

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Kowa Research Institute

NCT06247735

ACTIVE NOT RECRUITING 30 participants

A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

Ipsen

NCT07049887

COMPLETED Phase 3 265 participants

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

Gilead Sciences

NCT03602560

Phase Distribution

PhaseTrial count
Phase 2 2
Phase 3 5

Top Sponsors

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Primary Biliary Cholangitis Trial Landscape

ClinicalTrials.gov lists 9 US studies indexed under Primary Biliary Cholangitis, and 4 of those are currently open to recruitment — roughly 44% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Primary Biliary Cholangitis shows 5 late-stage studies (Phase 3 and Phase 4 combined) alongside 2 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Primary Biliary Cholangitis is led by Gilead Sciences with 3 indexed trials, alongside 4 other organizations in the top contributor list. The list on this page surfaces up to 9 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Primary Biliary Cholangitis?

PlainTrial tracks 9 US clinical trials for Primary Biliary Cholangitis, of which 4 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Primary Biliary Cholangitis?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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