59 completed, 34 unknown, 15 recruiting, 13 terminated. 43 Phase 2, 31 Phase 3, 25 Not applicable, 24 Phase 4, 22 Phase 1.
Follow Ursodeoxycholic Acid: new trials by email Literature Review of Ursodeoxycholic Acid trials Research Report on Ursodeoxycholic Acid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of Adjunctive Ursodeoxycholic Acid on Oxidative Stress, Inflammation, and Organ Dysfunction in Adults With Sepsis Standard medical treatment, Ursodeoxycholic Acid - Sepsis | Phase 2 / Phase 3 | Not yet recruiting | Tanta University | 80 | 2026-10-01 | 2026-10-07 |
| Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer Disitamab vedotin, Toripalimab, Sitagliptin - Bladder Urothelial Carcinoma, Bladder Cancer | Phase 2 | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 80 | 2026-07-01 | 2026-07-21 |
| Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis UDCA (Ursodeoxycholic acid), Corticosteroids (Reference Treatment) - Immune-Mediated Cholestasis | Phase 2 | Recruiting | University Hospital, Montpellier | 94 | 2026-06-25 | 2026-09-09 |
| Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients. Ursodeoxycholic acid, Standard Medical Treatment - Chronic Liver Disease | Not applicable | Not yet recruiting | Institute of Liver and Biliary Sciences, India | 130 | 2026-06-18 | 2026-06-23 |
| Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors UDCA (Ursodeoxycholic acid), Placebo - Kidney Cancer | Phase 2 | Recruiting | Jinling Hospital, China | 162 | 2026-06-01 | 2026-10-15 |
| Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy Ursodiol 500 MG - Clostridioides Difficile Infection | Early Phase 1 | Not yet recruiting | Medical College of Wisconsin | 30 | 2026-05-01 | 2026-04-29 |
| Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis Ursodeoxycholic Acid, Supportive Care - Hepatitis A, Hepatitis E Virus Infection | Not applicable | Not yet recruiting | Combined Military Hospital, Pakistan | 88 | 2026-04-01 | 2026-04-13 |
| Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy Phototherapy with placebo, Phototherapy with ursodeoxycholic acid - Hyperbilirubinemia Indirect | Not applicable | Completed | Muhammad Aamir Latif | 220 | 2026-02-01 | 2026-10-09 |
| UDCA to Prevent Post-TIPS Hepatic Encephalopathy Ursodeoxycholic Acid (UDCA), Lactulose - Hepatic Encephalopathy (HE), TIPS | Not applicable | Not yet recruiting | West China Hospital | 270 | 2026-01-01 | 2025-12-09 |
| FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy Fenofibrate, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 132 | 2025-12-15 | 2025-12-29 |
| The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia Phototherapy, ursodeoxycholic acid (UDCA) - Hyperbilirubinemia, Neonatal Indirect | Not applicable | Recruiting | Tishreen University Hospital | 70 | 2025-06-26 | 2026-04-21 |
| Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia Methylprednisolone, Magnesium isoglycyrrhizinate, Glutathione - Drug Induced Liver Injury | Not applicable | Recruiting | General Hospital of Shenyang Military Region | 232 | 2025-06-24 | 2025-12-18 |
| Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid), Ademetionine - Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly | Not applicable | Recruiting | Phenomen Pharma | 90 | 2025-06-19 | 2025-07-23 |
| PD-L1 Inhibitor + RT ± Ursodeoxycholic Acid in Recurrent/Metastatic HER2-Neg Breast Cancer Ursodeoxycholic Acid (URSO), Radiotherapy, Adebrelimab (PD-L1 inhibitor) - Breast Cancer | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 70 | 2025-02-01 | 2025-02-24 |
| Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration: a Single Center, Randomized, Phase I Clinical Trial Secretome - Liver Cirrhosis | Phase 1 | Not yet recruiting | Baermed | 54 | 2024-12-01 | 2024-10-08 |
| Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance Ursodeoxycholic acid (UDCA) 500 mg, Placebo - Hyperlipidemia, Ursodeoxycholic Acid | Not applicable | Recruiting | First Affiliated Hospital Xi'an Jiaotong University | 128 | 2024-11-25 | 2026-06-30 |
| Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia Ursodeoxycholic Acid, Placebo - Gastric Intestinal Metaplasia | Phase 4 | Recruiting | Yongquan Shi | 196 | 2024-11-12 | 2025-12-05 |
| A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics Prednisone, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Phase 2 / Phase 3 | Enrolling by invitation | Han Ying | 244 | 2024-10-30 | 2026-10-29 |
| A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis Fenofibrate, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Early Phase 1 | Completed | Han Ying | 30 | 2024-09-14 | 2026-08-05 |
| Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia Zinc sulfate, Ursodeoxycholic acid - Neonatal Hyperbilirubinemia | Phase 4 | Completed | Amira Adel Fouly | 140 | 2024-09-01 | 2026-09-10 |
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Liver Cirrhosis, Biliary (24) · Non-alcoholic Fatty Liver Disease (7) · Cholestasis (6) · Diabetes Mellitus, Type 2 (6) · Fibrosis (5) · Gallstones (5) · Rare Diseases (5) · Cholestasis, Intrahepatic (4) · Gastrointestinal Diseases (4) · Genetic Diseases, Inborn (4) · Hepatitis, Autoimmune (4) · Liver Cirrhosis (4) · Liver Diseases (4) · Chemical and Drug Induced Liver Injury (3) · Cholangitis (3)
Daewoong Pharmaceutical Co. LTD. (7) · Tanta University (4) · National Center for Research Resources (NCRR) (3) · Xijing Hospital of Digestive Diseases (3) · Children's Hospital of Fudan University (2) · First Affiliated Hospital Xi'an Jiaotong University (2) · Han Ying (2) · Institute of Liver and Biliary Sciences, India (2) · Jinling Hospital, China (2) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · Radboud University Medical Center (2) · Seoul National University Hospital (2) · Teva Pharmaceuticals USA (2) · University of Banja Luka (2) · West China Hospital (2)
China (29) · United States (23) · Egypt (9) · Canada (7) · South Korea (7) · United Kingdom (6) · Spain (5) · France (4) · Germany (4) · Netherlands (4) · Italy (3) · Taiwan (3) · Bosnia and Herzegovina (2) · Denmark (2) · India (2)
Enass Yousef Osman, PHD (2) · Jae-Yong Chung, M.D., Ph.D (2) · Kenneth Setchell (2) · Mariam George Tadros Bolous, Master (2) · Medhat Ismail Abdel Hamid, Professor (2) · Nageh Ahmed El-Mahdy, Professor (2) · Ying Han, Doctor (2) · Adnan H Dayoub, Prof.Neonat (1) · Alberto Albanese, MD (1) · Ashish Gupta, MBBS, MPH (1) · Asmaa A Elsayed, PhD (1) · Atilla Ertan, M.D. (1) · Ayaz Ali, FCPS (1) · Benjamin Shneider, M.D. (1)
PMID 32716060, PMID 10051462, PMID 10343514, PMID 10347106, PMID 11495032, PMID 12360466, PMID 15017671, PMID 15128074, PMID 15468571, PMID 16299032, PMID 16400329, PMID 16530513, PMID 16729326, PMID 16848809, PMID 16863557, PMID 17399846, PMID 17573387, PMID 17622601, PMID 18752324, PMID 19554543, PMID 19585548, PMID 19723493, PMID 19880582, PMID 21574172, PMID 21608000, PMID 21839040, PMID 21899713, PMID 21940902, PMID 22245904, PMID 22259000, PMID 22271046, PMID 22300693, PMID 22806342, PMID 22821944, PMID 22911624, PMID 23141888, PMID 23919274, PMID 23978872, PMID 24053627, PMID 24245549, PMID 24625898, PMID 24671010, PMID 24852569, PMID 24942592, PMID 25316553, PMID 25393877, PMID 25445618, PMID 25500425, PMID 25664595, PMID 26659833
2008 (1), 2016 (1), 2025 (1), N01CN35158 (1), P30CA016672 (1), P30CA023074 (1), P30CA033572 (1), P50CA095060 (1), R01DK056924 (1)