Primary biliary cholangitis

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ORPHA:186OMIM:109720K74.3
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4FDA treatments39Active trials59Specialists8Treatment centers2Financial resources

Where are you in your journey?

UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Primary Biliary Cholangitis is treated with 1 medication in our database, including Ursodiol. Medications are manufactured by AvKARE. Patients and caregivers can find copay cards, patient assistance programs, and travel grants for Primary Biliary Cholangitis treatment below.

Also known as:

Clinical phenotype terms— hover any for plain English:

Biliary cirrhosisHP:0002613Conjugated hyperbilirubinemiaHP:0002908Dermatographic urticariaHP:0011971Antimitochondrial antibody positivityHP:0030167XanthelasmaHP:0001114Orthostatic hypotensionHP:0001278Hepatocellular carcinomaHP:0001402Recurrent fungal infectionsHP:0002841Abnormal circulating lipid concentrationHP:0003119
Inheritance

Multifactorial

Caused by a mix of several genes and environmental factors

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Jun 2026TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

Tharimmune Inc — PHASE2

TrialNOT YET RECRUITING
Mar 2026Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Zydus Therapeutics Inc. — PHASE3

TrialNOT YET RECRUITING
Feb 2026Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

Zydus Therapeutics Inc. — PHASE3

TrialNOT YET RECRUITING
Feb 2026Biochemical Response and Clinical Outcomes in Patients With PBC

RenJi Hospital

TrialRECRUITING
Jan 2026LIVDELZI: New indication approved
FDAcompleted
Jan 2026The Value of Spleen Stiffness Measurement in Patients With PBC

Universitair Ziekenhuis Brussel — NA

TrialNOT YET RECRUITING
Dec 2025FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy

Xijing Hospital of Digestive Diseases — PHASE3

TrialRECRUITING
Dec 2025A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA

Cascade Pharmaceuticals, Inc — PHASE3

TrialRECRUITING
Dec 2025Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation

Centre Hospitalier Intercommunal Creteil

TrialNOT YET RECRUITING
Sep 2025Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)

Hospital Universitario La Paz

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

4 available

Livdelzi

seladelpar· Gilead Sciences, Inc.Orphan Drug
treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate U

treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA

Iqirvo

elafibranor· Ipsen Bioscience Inc.Orphan Drug
treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate U

treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA

OCALIVA

obeticholic acid· Intercept Pharmaceuticals, Inc.Orphan Drug

Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA

URSO 250

Ursodiol· Aptalis Pharma US, Inc.Orphan Drug

Clinical Trials

20 recruitingView all trials with filters →
Phase 35 trials
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Phase 3
Active
PI: Ipsen Medical Director (Ipsen) · Sites: Chandler, Arizona; Los Angeles, California +113 more · Age: 1875 yrs
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Phase 3
Actively Recruiting
PI: Ying Han, Doctor (The First Affiliated Hospital of Air Force Medicia) · Sites: Lanzhou, Gansu; Guangzhou, Guangdong +5 more · Age: 1875 yrs
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
Phase 3
Actively Recruiting
· Sites: Xi'an, Shaanxi · Age: 1875 yrs
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
Phase 3
Actively Recruiting
PI: Ma Xiong, MD (Renji Hospital, School of Medicine, Shanghai Jiao ) · Sites: Hefei, Anhui; Hefei, Anhui +39 more · Age: 1875 yrs
Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Phase 3
Actively Recruiting
· Sites: Xi'an, Shaanxi · Age: 1875 yrs
Phase 41 trial
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Phase 4
Actively Recruiting
PI: Li Wang (Peking Union Medical College Hospital) · Sites: Beijing · Age: 1899 yrs
Other14 trials
sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Active
· Sites: Aarhus C, Central Jutland · Age: 1899 yrs
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.
Active
· Sites: Aarhus · Age: 1899 yrs
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Actively Recruiting
· Sites: Madrid · Age: 1880 yrs
Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
Actively Recruiting
PI: Maria Carlota Londoño Londoño (Asociación Española para el Estudio del Hígado) · Sites: Barcelona · Age: 1899 yrs
LEOPARD Training and Validation Data Collection Study
Actively Recruiting
· Sites: Vienna; Ghent +20 more · Age: 1870 yrs
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Actively Recruiting
· Sites: Terrassa, Barcelona · Age: 1899 yrs
Biochemical Response and Clinical Outcomes in Patients With PBC
Actively Recruiting
PI: Xiong Ma, MD, PhD (RenJi Hospital) · Sites: Shanghai, Shanghai Municipality · Age: 1885 yrs
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
Active
PI: Ipsen Medical Director (Ipsen) · Sites: Chandler, Arizona; Miami, Florida +1 more · Age: 1899 yrs
sCD163 in PBC Patients - Assessment of Treatment Response
Actively Recruiting
· Sites: Aarhus C, Central Jutland · Age: 1899 yrs
National Database on Primary Biliary Cholangitis
Actively Recruiting
· Sites: Ancona; Bari +53 more · Age: 1899 yrs
Swiss Primary Biliary Cholangitis Cohort Study
Actively Recruiting
· Sites: Lugano, Canton Ticino; Basel +11 more · Age: 1899 yrs
PBC Long-term Outcomes Study
Actively Recruiting
· Sites: Beijing, Select A State Or Province
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Actively Recruiting
PI: Henning Grønbæk, Prof, MD (Aarhus University Hospital) · Sites: Aarhus N, Central Jutland; Hvidovre · Age: 1899 yrs
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Actively Recruiting
PI: Ipsen Medical Director (Ipsen) · Sites: Coronado, California; Los Angeles, California +61 more

Specialists

Showing 25 of 59View all specialists →
PT
Puneeta Tandon
Specialist
PI on 2 active trials19 Primary biliary cholangitis publications
DP
Deven Parmar
Specialist
PI on 2 active trials10 Primary biliary cholangitis publications
MM
Michael Trauner, M.D.
OXNARD, CA
Specialist
PI on 1 active trial
CM
Cynthia Levy, MD
Specialist
PI on 4 active trials
MP
Michael Trauner, Prof
OXNARD, CA
Specialist
PI on 1 active trial
MP
Michael P Manns, Prof
GRESHAM, OR
Specialist
PI on 1 active trial
RD
Rong Deng
NEW YORK, NY
Specialist
PI on 2 active trials14 Primary biliary cholangitis publications
CM
Christophe Corpechot, MD
Paris
Specialist

Rare Disease Specialist

PI on 2 active trials
TM
Theo Heller, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 8 active trials
AM
Andrew Mason, MD
Specialist
PI on 2 active trials1 Primary biliary cholangitis publication
AM
Alexander Miethke, MD
CINCINNATI, OH
Specialist
PI on 2 active trials1 Primary biliary cholangitis publication
CJ
Channa Jayasekera
SCOTTSDALE, AZ
Specialist
PI on 1 active trial
SP
Stephen J Rossi, PharmD
Specialist
PI on 3 active trials
JM
Joshua R Korzenik, MD
Specialist
PI on 1 active trial
DF
David EJ Jones, BA, BM, MRCP, PhD, FRCP
Specialist
PI on 1 active trial
ID
Ipsen Medical, Director
Specialist
PI on 5 active trials
ZM
Zhao wei feng, Master
Specialist
PI on 1 active trial
AM
Aldo Torre Delgadillo, M.D. M.Sc
Specialist
PI on 2 active trials
JM
Joshua Korzenik, MD
Specialist
PI on 2 active trials
KM
Konstantinos N Lazaridis, M.D.
ROCHESTER, MN
Specialist
PI on 2 active trials
AM
Andrew Muir, MD
IMPERIAL, MO
Specialist
PI on 4 active trials1 Primary biliary cholangitis publication
LP
Lise L Gluud, Professor
Specialist
PI on 1 active trial
NP
Nicolai J Wewer Albrechtsen, MD, PhD
Specialist
PI on 1 active trial
GH
George Hanna
Specialist
PI on 2 active trials7 Primary biliary cholangitis publications

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Financial Resources

2 resources
Livdelzi(seladelpar)Gilead Sciences, Inc.

Lynavoy

GlaxoSmithKline

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copay card
copay assistancePatient Assistance
Accepting applications

Travel Grants

No travel grants are currently matched to Primary biliary cholangitis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Primary biliary cholangitis

1 articles
AdvocacyRSSApr 22, 2026
PBC Summit Centers the Voices of People Living With the Disease
The PBC Foundation International Summit is a conference where people living with primary biliary cholangitis (PBC)—a rare liver disease—share their experiences
See all news about Primary biliary cholangitis

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Primary biliary cholangitis

What is Primary biliary cholangitis?

Primary Biliary Cholangitis is treated with 1 medication in our database, including Ursodiol. Medications are manufactured by AvKARE. Patients and caregivers can find copay cards, patient assistance programs, and travel grants for Primary Biliary Cholangitis treatment below.

How is Primary biliary cholangitis inherited?

Primary biliary cholangitis follows a multifactorial inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Primary biliary cholangitis typically begin?

Typical onset of Primary biliary cholangitis is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Primary biliary cholangitis?

Yes — 20 recruiting clinical trials are currently listed for Primary biliary cholangitis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Primary biliary cholangitis?

25 specialists and care centers treating Primary biliary cholangitis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Primary biliary cholangitis?

1 FDA-approved treatment and 4 patient support programs are currently tracked on UniteRare for Primary biliary cholangitis. See the treatments and support programs sections for copay assistance, eligibility, and contact details.