Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic utility of ursodeoxycholic acid across metabolic, hepatic, and systemic pathologies, including primary biliary cirrhosis, nonalcoholic steatohepatitis, type 2 diabetes mellitus, transthyretin amyloidosis, and toxic hepatitis. Sponsored by diverse academic institutions, hospitals, and pharmaceutical companies, these investigations encompass completed, active, terminated, unknown, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06755151 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2024-01-17 PHASE3
NCT06755541 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2024-01-30 PHASE3
NCT07795151 NOT_YET_RECRUITING
Primary Biliary Cholangitis
Beijing 302 Hospital
 2026-08-31 PHASE1; PHASE2
NCT07296458 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2025-12-15 PHASE3
NCT06842472 NOT_YET_RECRUITING
Breast Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2025-02 PHASE2
NCT07378761 NOT_YET_RECRUITING
Immune-Mediated Cholestasis
University Hospital, Montpellier
 2026-12 PHASE2
NCT07424677 NOT_YET_RECRUITING
Primary Biliary Cholangitis
Zydus Therapeutics Inc.
 2026-06 PHASE3
NCT07717242 RECRUITING
Bladder Urothelial Carcinoma; Bladder Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2026-07-01 PHASE2
NCT06591468 ENROLLING_BY_INVITATION
Primary Biliary Cholangitis (PBC)
Han Ying
 2024-10-30 PHASE2; PHASE3
NCT05925309 RECRUITING
Biliary Atresia; Cholangitis; Anti-Bacterial Agents
Children's Hospital of Fudan University
 2023-07-01
NCT06443606 RECRUITING
BPC; Non Optimal Response to UDCA
Assistance Publique - Hôpitaux de Paris
 2025-03-27 PHASE3
NCT07282353 RECRUITING
Primary Biliary Cholangitis
Cascade Pharmaceuticals, Inc
 2025-12-01 PHASE3
NCT05749822 RECRUITING
Primary Biliary Cholangitis
Xijing Hospital of Digestive Diseases
 2023-02-17 PHASE2; PHASE3
NCT05751967 RECRUITING
Primary Biliary Cholangitis
Xijing Hospital of Digestive Diseases
 2023-02-22 PHASE3
NCT07664020 NOT_YET_RECRUITING
Chronic Liver Disease
Institute of Liver and Biliary Sciences, India
 2026-06-18
NCT04924868 RECRUITING
Acute Pancreatitis Due to Gallstones
Hospital General Universitario de Alicante
 2021-11-10 PHASE3
NCT07273734 NOT_YET_RECRUITING
Hepatic Encephalopathy (HE); TIPS
West China Hospital
 2026-01-01
NCT06884748 NOT_YET_RECRUITING
Clostridioides Difficile Infection
Medical College of Wisconsin
 2026-05-01 EARLY_PHASE1
NCT06294847 RECRUITING
Retinal Detachment
Hopital Foch
 2024-08-20 PHASE3
NCT06922669 RECRUITING
Drug Induced Liver Injury
General Hospital of Shenyang Military Region
 2025-06-24
NCT07110987 RECRUITING
Hyperbilirubinemia, Neonatal Indirect
Tishreen University Hospital
 2025-06-26
NCT06684106 RECRUITING
Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance
First Affiliated Hospital Xi'an Jiaotong University
 2024-11-25
NCT06610760 RECRUITING
Gastric Intestinal Metaplasia
Yongquan Shi
 2024-11-12 PHASE4
NCT07672860 RECRUITING
Kidney Cancer
Jinling Hospital, China
 2026-06-01 PHASE2
NCT07525401 NOT_YET_RECRUITING
Hepatitis A; Hepatitis E Virus Infection
Combined Military Hospital, Pakistan
 2026-04
NCT06174402 ACTIVE_NOT_RECRUITING
Primary Biliary Cholangitis
Han Ying
 2023-08-21 PHASE2; PHASE3
NCT06383403 COMPLETED
Primary Biliary Cholangitis
Ipsen
 2024-07-09 PHASE3
NCT06517862 RECRUITING
Neonatal Hyperbilirubinemia
Amira Adel Fouly
 2024-09-01 PHASE4
NCT06060665 COMPLETED
Primary Biliary Cholangitis
Gilead Sciences
 2023-09-05 PHASE3
NCT03724175 TERMINATED
Ulcerative Colitis; Pouchitis
Stanford University
 2019-08-26 PHASE2; PHASE3
NCT07102979 TERMINATED
Liver Fibrosis
Chang Gung Memorial Hospital
 2024-01-01
NCT03004118 UNKNOWN
Functional Dyspepsia
Universitaire Ziekenhuizen KU Leuven
 2017-01 PHASE4
NCT04594694 TERMINATED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2019-10-02 PHASE2
NCT06591455 COMPLETED
Primary Biliary Cholangitis (PBC)
Han Ying
 2024-09-14 EARLY_PHASE1
NCT07068191 RECRUITING
Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD); Fatty Liver; Fatty Liver, Alcoholic; Fatty Liver, Nonalcoholic; Fatty Liver Disease
Phenomen Pharma
 2025-06-19
NCT06247735 COMPLETED
Primary Biliary Cholangitis
Kowa Research Institute, Inc.
 2024-02-07 PHASE2
NCT04650243 RECRUITING
Primary Biliary Cholangitis
Peking Union Medical College Hospital
 2020-01-21 PHASE4
NCT06918080 ACTIVE_NOT_RECRUITING
Non Alcoholic Fatty Liver Diseases (NAFLD); Obesity and Overweight; Acute Lymphoblastic Leukemia
Ain Shams University
 2023-11-19 PHASE4
NCT04810156 UNKNOWN
Hepatitis, Drug-Induced
Inge Marie Svane
 2021-04-07 PHASE2
NCT05467553 UNKNOWN
Hepatitis D
National Taiwan University Hospital
 2023-02-24 PHASE2
NCT04407650 ACTIVE_NOT_RECRUITING
Gestational Diabetes
King's College London
 2021-07-01 PHASE4
NCT06091787 COMPLETED
Liver Regeneration; Ursodeoxycholic Acid; Partial Liver Resection
Institute of Liver and Biliary Sciences, India
 2023-09-01
NCT05902468 UNKNOWN
Diabetes Mellitus, Type 2
Tanta University
 2023-06-28 PHASE2; PHASE3
NCT05416580 UNKNOWN
Diabetes Mellitus, Type 2
University of Banja Luka
 2022-09-12 PHASE3
NCT07072949 COMPLETED
Type 2 Diabetes Mellitus
University of Banja Luka
 2023-01-03 PHASE1
NCT05526807 TERMINATED
Clostridioides Difficile Infection
Nottingham University Hospitals NHS Trust
 2019-05-08
NCT02823366 UNKNOWN
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-01 PHASE3
NCT05973370 COMPLETED
Rheumatoid Arthritis
Tanta University
 2023-05-01 PHASE2
NCT04542473 UNKNOWN
SEPSIS; MALNUTRITION, CHILD
University of Oxford
 2021-07-01 PHASE2; PHASE3
NCT06715319 COMPLETED
PBC
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
 2021-10-09 PHASE3
NCT04620733 COMPLETED
Primary Biliary Cholangitis
Gilead Sciences
 2021-04-21 PHASE3
NCT04526665 ACTIVE_NOT_RECRUITING
Primary Biliary Cirrhosis
Ipsen
 2020-09-24 PHASE3
NCT05690646 COMPLETED
Cardiac Surgery
China National Center for Cardiovascular Diseases
 2023-01-28 PHASE4
NCT05659654 COMPLETED
COVID-19
Institute of Hematology & Blood Diseases Hospital, China
 2022-12-16 PHASE1; PHASE2
NCT04309773 UNKNOWN
Primary Sclerosing Cholangitis; Cholestasis
Assistance Publique - Hôpitaux de Paris
 2021-04-06 PHASE3
NCT05832697 COMPLETED
Healthy Subject
Daewoong Pharmaceutical Co. LTD.
 2022-01-27 PHASE1
NCT04618575 UNKNOWN
Hepatitis; Primary Biliary Cholangitis; Autoimmune
West China Hospital
 2021-03-17 PHASE4
NCT04617561 UNKNOWN
Hepatitis, Autoimmune; Primary Biliary Cholangitis
West China Hospital
 2020-11-01 PHASE4
NCT05410535 COMPLETED
Gastric Cancer
Daewoong Pharmaceutical Co. LTD.
 2021-09-15 PHASE4
NCT03954327 COMPLETED
Primary Biliary Cholangitis
University of Alberta
 2021-03-01 PHASE2
NCT02936596 UNKNOWN
Hepatitis, Autoimmune; Cholangitis; Liver Cirrhosis, Biliary; Cholestasis
Xiaoli Fan
 2016-12
NCT04834557 COMPLETED
Rheumatoid Arthritis
Tanta University
 2021-11-01 PHASE2
NCT02823353 COMPLETED
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-04-08 PHASE3
NCT02967250 COMPLETED
Parkinson Disease
University of Minnesota
 2020-04-01 PHASE1
NCT06127355 COMPLETED
Gestational Diabetes
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
 2021-03-03 PHASE3
NCT04786795 UNKNOWN
Patients With Dyspeptic Symptoms After Cholecystectomy
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
 2021-03-01 PHASE4
NCT03602976 TERMINATED
Hepatic Sarcoidosis, Elevated Alkaline Phosphatase
Ethan Weinberg
 2018-08-20 PHASE2
NCT04937023 UNKNOWN
Bone Regeneration
SVS Institute of Dental Sciences
 2021-06-11
NCT04910178 COMPLETED
Diabetes Type 2; NAFLD
Asmaa Abdelfattah Elsayed
 2020-12-01 PHASE4
NCT03678480 WITHDRAWN
Primary Sclerosing Cholangitis; Cholangitis; Cholangitis, Sclerosing; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adolescent
HighTide Therapeutics (Hong Kong) Limited
 2021-03-01 PHASE2
NCT05043194 UNKNOWN
Cholestasis of Parenteral Nutrition
Wei Liu
 2021-01-01
NCT02965911 WITHDRAWN
Primary Biliary Cirrhosis
Beijing 302 Hospital
 2016-01 PHASE1; PHASE2
NCT04751188 UNKNOWN
Primary Biliary Cirrhosis
Instituto Mexicano del Seguro Social
 2020-10-02 PHASE3
NCT03840005 COMPLETED
Parkinson's Disease
Sheffield Teaching Hospitals NHS Foundation Trust
 2018-12-18 PHASE2
NCT03462940 TERMINATED
Diabetes Mellitus, Type 2; Insulin Response; Endothelial Dysfunction
Boston University
 2018-04-02
NCT03521297 UNKNOWN
Primary Biliary Cholangitis (PBC)
Sun Yat-sen University
 2020-01-20 PHASE2
NCT03664596 COMPLETED
Non-alcoholic Steatohepatitis
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
 2018-08-01
NCT03665519 COMPLETED
Primary Biliary Cirrhosis
National Scientific Medical Center, Kazakhstan
 2018-01-03
NCT04977661 COMPLETED
Nonalcoholic Steatohepatitis (NASH)
Kafrelsheikh University
 2020-02-01 PHASE4
NCT03201952 TERMINATED
Glucose Intolerance; Gastric Bypass Surgery
Vanderbilt University Medical Center
 2018-02-01 PHASE1
NCT03602560 COMPLETED
Primary Biliary Cholangitis
Gilead Sciences
 2018-10-01 PHASE3
NCT03394924 COMPLETED
Primary Biliary Cholangitis
Enanta Pharmaceuticals, Inc
 2017-12-27 PHASE2
NCT00746486 TERMINATED
Primary Biliary Cirrhosis
Dr. Falk Pharma GmbH
 2009-02 PHASE3
NCT03476993 TERMINATED
Liver Cirrhosis, Biliary
Biocad
 2018-04-27 PHASE2
NCT03056274 UNKNOWN
Intrahepatic Cholestases; Pregnancy Complications
Epsom and St Helier University Hospitals NHS Trust
 2019-01 PHASE2; PHASE3
NCT03226067 COMPLETED
Primary Biliary Cirrhosis
Calliditas Therapeutics AB
 2017-06-26 PHASE2
NCT02937012 UNKNOWN
Primary Biliary Cirrhosis
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-10 PHASE3
NCT02916641 UNKNOWN
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-01 PHASE3
NCT02916290 UNKNOWN
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-01 PHASE3
NCT03124108 COMPLETED
Primary Biliary Cholangitis (PBC)
Genfit
 2017-04-05 PHASE2
NCT02078882 COMPLETED
Primary Biliary Cirrhosis
Christopher Bowlus, MD
 2014-09 PHASE4
NCT02955602 COMPLETED
Primary Biliary Cirrhosis
Gilead Sciences
 2016-11-28 PHASE2
NCT02721862 UNKNOWN
Cholelithiasis
American University of Beirut Medical Center
 2016-03 PHASE3
NCT03092765 TERMINATED
Primary Biliary Cholangitis
EA Pharma Co., Ltd.
 2017-05-29 PHASE2
NCT03659058 COMPLETED
Fibrosis, Liver
Zagazig University
 2016-03-02
NCT04484870 COMPLETED
Choledocholithiasis; Recurrence
First People's Hospital of Hangzhou
 2017-03-01 PHASE4
NCT03489889 COMPLETED
Ursodeoxycholic Acid; Primary Biliary Cirrhosis
University of Sao Paulo General Hospital
 2016-12
NCT01149304 COMPLETED
Colorectal Cancer; Liver Metastases; Irradiation Damage; Radiation Induced Liver Disease
University of Magdeburg
 2009-06 PHASE2
NCT02943707 UNKNOWN
Liver Diseases
Wenzhou Medical University
 2016-10 PHASE2
NCT02472509 TERMINATED
Hemolytic Disorders; Gallstones
Shaare Zedek Medical Center
 2014-12 PHASE4
NCT02841306 COMPLETED
Rhegmatogenous Retinal Detachment
Francine Behar-Cohen
 2016-07 PHASE1
NCT03000218 UNKNOWN
Overweight; Abnormal Liver Function Tests
Seoul National University Hospital
 2016-08 PHASE1
NCT02033876 COMPLETED
Type 2 Diabetes Mellitus
Mayo Clinic
 2013-10 PHASE2
NCT02338635 UNKNOWN
End-Stage Kidney Disease
Ewha Womans University
 2015-07 PHASE4
NCT01088607 COMPLETED
Primary Sclerosing Cholangitis
University of Tennessee
 2010-10 PHASE1
NCT02609048 TERMINATED
Primary Biliary Cirrhosis (PBC)
Gilead Sciences
 2015-11-04 PHASE2
NCT02789644 UNKNOWN
Aged
Seoul National University Hospital
 2016-05 PHASE1
NCT02420496 WITHDRAWN
Cholestasis; Liver Disease
The University of Texas Health Science Center at San Antonio
 2016-06 PHASE2
NCT01974336 COMPLETED
Short Bowel Syndrome
Jinling Hospital, China
 2013-01 PHASE4
NCT02622685 COMPLETED
Healthy
Daewoong Pharmaceutical Co. LTD.
 2015-05 PHASE1
NCT01899703 COMPLETED
Cholestasis, Intrahepatic
GlaxoSmithKline
 2014-03-10 PHASE2
NCT02021110 COMPLETED
Polycystic Liver Disease; Polycystic Kidney, Autosomal Dominant
Radboud University Medical Center
 2013-12 PHASE2
NCT02415777 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT01904058 COMPLETED
PBC; Primary Biliary Cirrhosis
Mirum Pharmaceuticals, Inc.
 2013-08 PHASE2
NCT02340247 COMPLETED
Severe Obesity
Hvidovre University Hospital
 2014-11 PHASE4
NCT02418130 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT02026401 COMPLETED
Primary Biliary Cirrhosis
NGM Biopharmaceuticals, Inc
 2014-02 PHASE2
NCT02016365 COMPLETED
Transthyretin Amyloidosis; Cardiomyopathy
Umeå University
 2012-02 PHASE2
NCT01456468 COMPLETED
Cholangitis, Sclerosing
Yale University
 2011-10 PHASE1
NCT01097304 COMPLETED
Barrett Esophagus; Esophageal Carcinoma
National Cancer Institute (NCI)
 2010-04 PHASE2
NCT01440309 UNKNOWN
Primary Biliary Cirrhosis
Robert Chunhua Zhao, MD, PhD
 2011-11 PHASE1
NCT01226823 WITHDRAWN
Intrahepatic Cholestasis of Pregnancy
University of Bologna
 2010-11 PHASE3
NCT01688375 UNKNOWN
Obstructive Jaundice
University Clinical Centre of Kosova
 2012-12 PHASE2
NCT01389973 COMPLETED
Primary Biliary Cirrhosis
Janssen Research & Development, LLC
 2011-09 PHASE2
NCT00858858 COMPLETED
Gastroesophageal Reflux Disease
US Department of Veterans Affairs
 2009-03
NCT01337440 UNKNOWN
Type 2 Diabetes Mellitus; Chronic Liver Disease
Kanazawa University
 2010-04 PHASE4
NCT01857284 COMPLETED
Primary Biliary Cirrhosis
Beijing Friendship Hospital
 2009-09 PHASE3
NCT01829698 COMPLETED
Cholestatic Liver Disease
Beijing Trendful Kangjian Medical Information Consulting Limited Company
 2009-08 PHASE3
NCT00873275 COMPLETED
Colorectal Cancer
City of Hope Medical Center
 2009-03-11 PHASE1
NCT00877604 COMPLETED
Amyotrophic Lateral Sclerosis
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
 2008-06 PHASE2
NCT00808743 COMPLETED
Familial Adenomatous Polyposis; Duodenal Neoplasms; Duodenal Polyps
Radboud University Medical Center
 2009-05 PHASE2; PHASE3
NCT01510860 COMPLETED
Primary Biliary Cirrhosis
Dr. Falk Pharma GmbH
 2008-11 PHASE4
NCT01141322 UNKNOWN
Hepatitis, Toxic
Taipei Veterans General Hospital, Taiwan
 2007-08 PHASE4
NCT01548079 COMPLETED
Non-alcoholic Fatty Liver Disease; Morbid Obesity
Sahlgrenska University Hospital
 2008-10
NCT00550862 TERMINATED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2007-10 PHASE2
NCT00134758 UNKNOWN
Adenomatous Polyposis Coli, Familial
Assistance Publique - Hôpitaux de Paris
 2004-10 PHASE2; PHASE3
NCT00059202 TERMINATED
Primary Sclerosing Cholangitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2002-07 PHASE2; PHASE3
NCT01073202 COMPLETED
Liver Transplantation; Ischemia-reperfusion Injury; Cholestasis
Shanghai Jiao Tong University School of Medicine
 2005-05
NCT00857480 COMPLETED
Hepatic Cirrhosis
Norgine
 2006-06 PHASE1
NCT01576458 COMPLETED
Intrahepatic Cholestasis; Pregnancy
Turku University Hospital
 1998-01 PHASE3
NCT00161083 COMPLETED
Cholecystolithiasis
UMC Utrecht
 2001-11 PHASE4
NCT00285597 UNKNOWN
Heart Failure, Congestive
National Heart and Lung Institute
 2004-05 PHASE2
NCT00200343 COMPLETED
Chronic Hepatitis C
Tanabe Pharma Corporation
 2002-07 PHASE3
NCT01141296 WITHDRAWN
Primary Biliary Cirrhosis
University of Miami
 2011-04 PHASE2
NCT01430429 TERMINATED
Primary Biliary Cirrhosis
Light Chain Bioscience - Novimmune SA
 PHASE2
NCT00004441 COMPLETED
Cystic Fibrosis
Children's Hospital Medical Center, Cincinnati
 1997-09

(data from https://clinicaltrials.gov, updated on 2026-01-08)

Check the Ursodeoxycholic acid sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ursodeoxycholic acid sodium expands the hydrophilic bile acid pool and modulates nuclear receptors such as the farnesoid X receptor, thereby displacing cytotoxic hydrophobic bile acids, suppressing mitochondrial apoptotic pathways, and enhancing hepatobiliary secretion. This hepatoprotective and choleretic cascade reduces cellular membrane damage and tissue inflammation, directly mitigating hepatic injury and cholestasis in clinical conditions such as primary biliary cirrhosis and nonalcoholic steatohepatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.