Primary sclerosing cholangitis

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ORPHA:171OMIM:602114K83.0
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24Active trials30Specialists8Treatment centers

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

Primary sclerosing cholangitis (PSC) is a chronic, progressive cholestatic liver disease characterized by inflammation and fibrosis of the intrahepatic and/or extrahepatic bile ducts. This process leads to multifocal bile duct strictures (narrowing) and eventually biliary cirrhosis, liver failure, and an increased risk of cholangiocarcinoma (bile duct cancer). PSC primarily affects the hepatobiliary system but is strongly associated with inflammatory bowel disease (IBD), particularly ulcerative colitis, which occurs in approximately 60–80% of PSC patients. Key symptoms include fatigue, pruritus (itching), jaundice, right upper quadrant abdominal pain, and recurrent episodes of bacterial cholangitis (bile duct infection) with fever and chills. As the disease progresses, patients may develop portal hypertension, hepatosplenomegaly, fat-soluble vitamin deficiencies, and metabolic bone disease. Laboratory findings typically show elevated alkaline phosphatase and gamma-glutamyl transferase levels. Diagnosis is usually established by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP), which reveal the characteristic beaded appearance of bile ducts due to alternating strictures and dilatations. There is currently no approved pharmacological therapy that has been proven to halt or reverse the progression of PSC. Ursodeoxycholic acid (UDCA) is commonly prescribed and may improve liver biochemistry, but its impact on long-term outcomes remains debated. Management is largely supportive, focusing on treatment of pruritus, nutritional supplementation, management of cholangitis episodes, endoscopic dilation of dominant strictures, and surveillance for cholangiocarcinoma and colorectal cancer in patients with concurrent IBD. Liver transplantation remains the only definitive treatment for end-stage PSC, though the disease can recur in the transplanted liver in approximately 20–25% of cases. PSC is more common in males, with a male-to-female ratio of approximately 2:1.

Also known as:

Clinical phenotype terms— hover any for plain English:

Abnormal biliary tract morphologyHP:0012440Elevated alkaline phosphatase of hepatic originHP:0010638Spider hemangiomaHP:0012522Abnormal large intestine physiologyHP:0012700Dilated superficial abdominal veinsHP:0030168Ulcerative colitisHP:0100279Palmar telangiectasiaHP:0100869
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
Aug 2026Sauna for Long Covid

Massachusetts General Hospital — NA

TrialRECRUITING
May 2026PET/MRI of Primary Sclerosing Cholangitis

Massachusetts General Hospital

TrialNOT YET RECRUITING
May 2026Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation

Assistance Publique - Hôpitaux de Paris — PHASE2

TrialNOT YET RECRUITING
Apr 2026A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis

Ipsen — PHASE3

TrialNOT YET RECRUITING
Apr 2026Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)

National Institute of Neurological Disorders and Stroke (NINDS) — PHASE1

TrialNOT YET RECRUITING
Jan 2026A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)

Takeda — PHASE1

TrialRECRUITING
Jan 2026Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis

McMaster University — PHASE2

TrialNOT YET RECRUITING
Nov 2025Brain Stimulation in Long COVID

Amsterdam UMC, location VUmc — NA

TrialRECRUITING
Nov 2025A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC

LISCure Biosciences — PHASE2

TrialRECRUITING
Sep 2025Heat thErapy And mobiLity in COVID-19 Survivors

University of Nebraska — NA

TrialRECRUITING

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

Treatments

No FDA-approved treatments are currently listed for Primary sclerosing cholangitis.

20 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

20 recruitingView all trials with filters →
Phase 32 trials
norUrsodeoxycholic Acid vs Placebo in PSC
Phase 3
Active
PI: Michael Trauner, MD (Medical University of Vienna, Department of Intern) · Sites: Vienna; Hanover, Lower Saxonia · Age: 1675 yrs
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Phase 3
Active
PI: Annika Bergquist, MD PhD (Karolinska University Hospital) · Sites: Malmo, Skåne County; Umeå, Västerbotten County +10 more · Age: 1875 yrs
Phase 29 trials
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Phase 2
Actively Recruiting
· Sites: Sacramento, California; Aurora, Colorado +5 more · Age: 1875 yrs
Vancomycin in Primary Sclerosing Cholangitis in Italy
Phase 2
Actively Recruiting
· Sites: Monza, Monza E Brianza · Age: 1570 yrs
Detoxification of the Liver In PSC (Dolphin)
Phase 2
Actively Recruiting
PI: Joshua A Korzenik, MD (Brigham and Womens Hospital) · Sites: Chestnut Hill, Massachusetts · Age: 1875 yrs
CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)
Phase 2
Active
PI: Rong Deng (Cascade Pharmaceuticals, Inc) · Sites: Hefei, Anhui; Beijing, Beijing Municipality +9 more · Age: 1875 yrs
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Phase 2
Active
· Sites: Coronado, California; Los Angeles, California +101 more · Age: 1299 yrs
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Phase 2
Actively Recruiting
PI: Aparna Goel, MD (Stanford University) · Sites: Redwood City, California; Stanford, California · Age: 1475 yrs
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Phase 2
Active
PI: Ipsen Medical, Director (Ipsen) · Sites: Lancaster, California; Los Angeles, California +60 more · Age: 1875 yrs
FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Phase 2
Actively Recruiting
· Sites: Birmingham; London +3 more · Age: 1899 yrs
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Phase 2
Actively Recruiting
PI: Channa Jayasekera (Mayo Clinic) · Sites: Scottsdale, Arizona · Age: 1875 yrs
Phase 11 trial
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
Phase 1
Actively Recruiting
PI: Study Director (Takeda) · Sites: Salt Lake City, Utah · Age: 1868 yrs
N/A3 trials
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
N/A
Active
PI: Piotr Milkiewicz, MD, PhD (Department of Hepatology, Transplantology and Inte) · Sites: Warsaw · Age: 1875 yrs
Gluten-free Diet in PSC and IBD
N/A
Active
· Sites: Prague, Prague · Age: 1865 yrs
Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
N/A
Actively Recruiting
· Sites: Milan, MI · Age: 1890 yrs
Other5 trials
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Actively Recruiting
PI: Theo Heller, M.D. (National Institute of Diabetes and Digestive and K) · Sites: Bethesda, Maryland · Age: 1890 yrs
Swiss Primary Sclerosing Cholangitis Cohort Study
Actively Recruiting
· Sites: Lugano, Canton Ticino; Basel +19 more
National Database on Primary Sclerosing Cholangitis (PSC)
Actively Recruiting
· Sites: Ancona; Bari +61 more · Age: 1799 yrs
Primary Sclerosing Cholangitis in Children
Actively Recruiting
PI: Cara Mack, MD (Medical College of Wisconsin-Milwaukee) · Sites: Los Angeles, California; Aurora, Colorado +10 more · Age: 225 yrs
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
Actively Recruiting
PI: Cynthia Levy, MD (University of Miami) · Sites: Sacramento, California; San Francisco, California +14 more · Age: 1875 yrs

Specialists

Showing 25 of 30View all specialists →
AP
Annika Bergquist, MD PhD
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 sclerosing cholangitis publications
MM
Mark D Topazian, MD
ROCHESTER, MN
Specialist
PI on 1 active trial
KM
Kenneth Cox, MD
Specialist
PI on 1 active trial
CJ
Channa Jayasekera
SCOTTSDALE, AZ
Specialist
PI on 1 active trial
AM
Alexander Miethke, MD
CINCINNATI, OH
Specialist
PI on 2 active trials1 Primary sclerosing cholangitis publication
AM
Amy E Taylor, MD
Specialist
PI on 1 active trial1 Primary sclerosing cholangitis publication
SP
Stephen J Rossi, PharmD
Specialist
PI on 3 active trials
SP
Stephen Rossi, PharmD
Specialist
PI on 1 active trial
BM
Byron P Vaughn, MD
MINNEAPOLIS, MN
Specialist
PI on 1 active trial
JM
Joshua R Korzenik, MD
Specialist
PI on 1 active trial
RM
Robert B Innis, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 8 active trials
AM
Andrew Muir, MD
IMPERIAL, MO
Specialist
PI on 4 active trials1 Primary sclerosing cholangitis publication
RD
Rajarshi Banerjee, BM BCh MSc DPhil
Specialist
PI on 1 active trial
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
Avindra Nath, M.D.
BALTIMORE, MD
Specialist
PI on 7 active trials
HP
Harry SOKOL, MD PhD
ALBANY, NY
Specialist
PI on 1 active trial

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

Travel Grants

No travel grants are currently matched to Primary sclerosing cholangitis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Primary sclerosing cholangitis

Disease timeline:

New recruiting trial: Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Heat thErapy And mobiLity in COVID-19 Survivors

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Brain Stimulation in Long COVID

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Sauna for Long Covid

A new clinical trial is recruiting patients for Primary sclerosing cholangitis

New recruiting trial: Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2

A new clinical trial is recruiting patients for Primary sclerosing 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 sclerosing cholangitis

What is Primary sclerosing cholangitis?

Primary sclerosing cholangitis (PSC) is a chronic, progressive cholestatic liver disease characterized by inflammation and fibrosis of the intrahepatic and/or extrahepatic bile ducts. This process leads to multifocal bile duct strictures (narrowing) and eventually biliary cirrhosis, liver failure, and an increased risk of cholangiocarcinoma (bile duct cancer). PSC primarily affects the hepatobiliary system but is strongly associated with inflammatory bowel disease (IBD), particularly ulcerative colitis, which occurs in approximately 60–80% of PSC patients. Key symptoms include fatigue, prurit

How is Primary sclerosing cholangitis inherited?

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

At what age does Primary sclerosing cholangitis typically begin?

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

Are there clinical trials for Primary sclerosing cholangitis?

Yes — 20 recruiting clinical trials are currently listed for Primary sclerosing 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 sclerosing cholangitis?

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