{"id":"ursodeoxycholic-acid","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Diarrhea"},{"rate":"5-15","effect":"Abdominal pain"},{"rate":"5-10","effect":"Nausea"},{"rate":"variable","effect":"Pruritus"},{"rate":"5","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2028234","moleculeType":"Small molecule","molecularWeight":"414.56"},"_dailymed":{"setId":"9f892c0a-8cab-4515-8074-fbfaa1781946","title":"URSODEOXYCHOLIC ACID (URSODIOL) POWDER [BLUEBAY SHANDONG CO.,LTD]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ursodeoxycholic acid (UDCA) is a naturally occurring hydrophilic bile acid that decreases the cholesterol content of bile and promotes its secretion, thereby reducing cholesterol crystallization and gallstone formation. It also has cytoprotective and immunomodulatory properties that reduce hepatocyte injury and inflammation in cholestatic liver diseases. The drug increases the proportion of hydrophilic bile acids in the bile acid pool, improving overall bile composition and hepatic function.","oneSentence":"Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and increases bile flow to improve hepatic function and reduce cholestasis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:37:43.238Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary biliary cholangitis (PBC)"},{"name":"Primary sclerosing cholangitis (PSC)"},{"name":"Gallstone dissolution"},{"name":"Cholestasis of pregnancy"},{"name":"Cystic fibrosis-associated liver disease"}]},"trialDetails":[{"nctId":"NCT06517862","phase":"PHASE4","title":"Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia","status":"RECRUITING","sponsor":"Amira Adel Fouly","startDate":"2024-09-01","conditions":"Neonatal Hyperbilirubinemia","enrollment":80},{"nctId":"NCT07477782","phase":"PHASE2","title":"Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2026-05","conditions":"Primary Sclerosing Cholangitis (PSC), Inflammatory Bowel Disease (IBD)","enrollment":72},{"nctId":"NCT03431896","phase":"","title":"Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2018-02-01","conditions":"Amyloidosis, Amyloid, Amyloid Neuropathies, Familial","enrollment":37},{"nctId":"NCT03724175","phase":"PHASE2, PHASE3","title":"The Role of Secondary Bile Acids in Intestinal Inflammation","status":"TERMINATED","sponsor":"Stanford University","startDate":"2019-08-26","conditions":"Ulcerative Colitis, Pouchitis","enrollment":2},{"nctId":"NCT07457632","phase":"PHASE2","title":"Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-04-01","conditions":"Diabetic Macular Edema (DME)","enrollment":69},{"nctId":"NCT06383403","phase":"PHASE3","title":"A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ipsen","startDate":"2024-07-09","conditions":"Primary Biliary Cholangitis","enrollment":69},{"nctId":"NCT04526665","phase":"PHASE3","title":"Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ipsen","startDate":"2020-09-24","conditions":"Primary Biliary Cirrhosis","enrollment":161},{"nctId":"NCT07424677","phase":"PHASE3","title":"Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy","status":"NOT_YET_RECRUITING","sponsor":"Zydus Therapeutics Inc.","startDate":"2026-03","conditions":"Primary Biliary Cholangitis","enrollment":89},{"nctId":"NCT07378761","phase":"PHASE2","title":"Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Montpellier","startDate":"2026-02","conditions":"Immune-Mediated Cholestasis","enrollment":94},{"nctId":"NCT06755151","phase":"PHASE3","title":"Fenofibrate in Primary Biliary Cholangitis: a Real World Study","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2024-01-17","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":300},{"nctId":"NCT05751967","phase":"PHASE3","title":"Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2023-02-22","conditions":"Primary Biliary Cholangitis","enrollment":150},{"nctId":"NCT06174402","phase":"PHASE2, PHASE3","title":"Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Han Ying","startDate":"2023-08-21","conditions":"Primary Biliary Cholangitis","enrollment":184},{"nctId":"NCT06755541","phase":"PHASE3","title":"Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2024-01-30","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":150},{"nctId":"NCT05749822","phase":"PHASE2, PHASE3","title":"Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2023-02-17","conditions":"Primary Biliary Cholangitis","enrollment":104},{"nctId":"NCT00200343","phase":"PHASE3","title":"Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2002-07","conditions":"Chronic Hepatitis C","enrollment":596},{"nctId":"NCT06415773","phase":"PHASE3","title":"Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin","status":"COMPLETED","sponsor":"HighTide Biopharma Pty Ltd","startDate":"2024-06-04","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":367},{"nctId":"NCT07282353","phase":"PHASE3","title":"A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA","status":"RECRUITING","sponsor":"Cascade Pharmaceuticals, Inc","startDate":"2025-12-01","conditions":"Primary Biliary Cholangitis","enrollment":135},{"nctId":"NCT06350890","phase":"PHASE3","title":"Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"HighTide Biopharma Pty Ltd","startDate":"2023-11-05","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":408},{"nctId":"NCT07296458","phase":"PHASE3","title":"FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2025-12-15","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":132},{"nctId":"NCT06091787","phase":"NA","title":"Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy","status":"COMPLETED","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2023-09-01","conditions":"Liver Regeneration, Ursodeoxycholic Acid, Partial Liver Resection","enrollment":90},{"nctId":"NCT06922669","phase":"NA","title":"Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia","status":"RECRUITING","sponsor":"General Hospital of Shenyang Military Region","startDate":"2025-06-24","conditions":"Drug Induced Liver Injury","enrollment":232},{"nctId":"NCT07273734","phase":"NA","title":"UDCA to Prevent Post-TIPS Hepatic Encephalopathy","status":"NOT_YET_RECRUITING","sponsor":"West China Hospital","startDate":"2026-01-01","conditions":"Hepatic Encephalopathy (HE), TIPS","enrollment":270},{"nctId":"NCT07110987","phase":"NA","title":"The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia","status":"RECRUITING","sponsor":"Tishreen University Hospital","startDate":"2025-06-26","conditions":"Hyperbilirubinemia, Neonatal Indirect","enrollment":70},{"nctId":"NCT06610760","phase":"PHASE4","title":"Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia","status":"RECRUITING","sponsor":"Yongquan Shi","startDate":"2024-11-12","conditions":"Gastric Intestinal Metaplasia","enrollment":196},{"nctId":"NCT06591468","phase":"PHASE2, PHASE3","title":"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","status":"ENROLLING_BY_INVITATION","sponsor":"Han Ying","startDate":"2024-10-30","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":244},{"nctId":"NCT06591455","phase":"EARLY_PHASE1","title":"A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis","status":"COMPLETED","sponsor":"Han Ying","startDate":"2024-09-14","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":30},{"nctId":"NCT06353347","phase":"PHASE3","title":"Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin","status":"COMPLETED","sponsor":"HighTide Biopharma Pty Ltd","startDate":"2023-11-13","conditions":"Type 2 Diabetes Mellitus","enrollment":551},{"nctId":"NCT04594694","phase":"PHASE2","title":"Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2019-10-02","conditions":"Primary Biliary Cholangitis","enrollment":75},{"nctId":"NCT06488911","phase":"PHASE3","title":"To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2024-07-01","conditions":"Primary Biliary Cholangitis","enrollment":63},{"nctId":"NCT06884748","phase":"EARLY_PHASE1","title":"Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy","status":"NOT_YET_RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2025-12-01","conditions":"Clostridioides Difficile Infection","enrollment":30},{"nctId":"NCT07005752","phase":"PHASE4","title":"A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).","status":"RECRUITING","sponsor":"Myungmoon Pharma. Co. Ltd.","startDate":"2025-07-28","conditions":"Cholesterol Cholelithiasis","enrollment":484},{"nctId":"NCT06684106","phase":"NA","title":"Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance","status":"RECRUITING","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2024-11-25","conditions":"Hyperlipidemia, Ursodeoxycholic Acid, Statin Therapy","enrollment":128},{"nctId":"NCT06247735","phase":"PHASE2","title":"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.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kowa Research Institute, Inc.","startDate":"2024-02-07","conditions":"Primary Biliary Cholangitis","enrollment":46},{"nctId":"NCT06443606","phase":"PHASE3","title":"Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-03-27","conditions":"BPC, Non Optimal Response to UDCA","enrollment":108},{"nctId":"NCT07122206","phase":"","title":"Monitoring the Response of Combination Ursodiol and Seladelpar Treatment","status":"NOT_YET_RECRUITING","sponsor":"Methodist Health System","startDate":"2025-08","conditions":"Primary Biliary Cholangitis","enrollment":100},{"nctId":"NCT07102979","phase":"NA","title":"Remedial Mechanism of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk of Bile Secretion, Gut Microbiome, and Host Immune Response","status":"ENROLLING_BY_INVITATION","sponsor":"Chang Gung Memorial Hospital","startDate":"2025-09-01","conditions":"Liver Cirrhosis","enrollment":150},{"nctId":"NCT07068191","phase":"NA","title":"Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly","status":"RECRUITING","sponsor":"Phenomen Pharma","startDate":"2025-06-19","conditions":"Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL)","enrollment":90},{"nctId":"NCT07072949","phase":"PHASE1","title":"The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin","status":"COMPLETED","sponsor":"University of Banja Luka","startDate":"2023-01-03","conditions":"Type 2 Diabetes Mellitus","enrollment":90},{"nctId":"NCT06365424","phase":"PHASE2, PHASE3","title":"Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2017-04-08","conditions":"Primary Biliary Cholangitis","enrollment":117},{"nctId":"NCT00873275","phase":"PHASE1","title":"Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer","status":"COMPLETED","sponsor":"City of Hope Medical Center","startDate":"2009-03-11","conditions":"Colorectal Cancer","enrollment":11},{"nctId":"NCT06294847","phase":"PHASE3","title":"Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery","status":"RECRUITING","sponsor":"Hopital Foch","startDate":"2024-08-20","conditions":"Retinal Detachment","enrollment":120},{"nctId":"NCT06060665","phase":"PHASE3","title":"Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gilead Sciences","startDate":"2023-09-05","conditions":"Primary Biliary Cholangitis","enrollment":90},{"nctId":"NCT02961413","phase":"","title":"A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）","status":"RECRUITING","sponsor":"Drug Induced Liver Disease Study Group","startDate":"2016-04","conditions":"Drug-induced Liver Injury","enrollment":10000},{"nctId":"NCT06864481","phase":"","title":"Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis","status":"RECRUITING","sponsor":"University Hospital, Montpellier","startDate":"2025-04-22","conditions":"Liver Injury, Secondary to Immune Checkpoint Inhibitors, Cancer Patients","enrollment":250},{"nctId":"NCT04407650","phase":"PHASE4","title":"Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus","status":"ACTIVE_NOT_RECRUITING","sponsor":"King's College London","startDate":"2021-07-01","conditions":"Gestational Diabetes","enrollment":64},{"nctId":"NCT06918080","phase":"PHASE4","title":"Hepatoprotective Measures for Children at High Risk of NAFLD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ain Shams University","startDate":"2023-11-19","conditions":"Non Alcoholic Fatty Liver Diseases (NAFLD), Obesity and Overweight, Acute Lymphoblastic Leukemia","enrollment":200},{"nctId":"NCT06026865","phase":"NA","title":"S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical University of Warsaw","startDate":"2023-08-01","conditions":"Primary Sclerosing Cholangitis (PSC)","enrollment":60},{"nctId":"NCT04650243","phase":"PHASE4","title":"Clinical Research of Tapering UDCA in PBC Patients With a Complete Response","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2020-01-21","conditions":"Primary Biliary Cholangitis","enrollment":90},{"nctId":"NCT03188146","phase":"","title":"Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2017-05-01","conditions":"Primary Biliary Cholangitis (PBC)","enrollment":57},{"nctId":"NCT04924868","phase":"PHASE3","title":"Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis","status":"RECRUITING","sponsor":"Hospital General Universitario de Alicante","startDate":"2021-11-10","conditions":"Acute Pancreatitis Due to Gallstones","enrollment":332},{"nctId":"NCT05256979","phase":"","title":"Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation","status":"ACTIVE_NOT_RECRUITING","sponsor":"General University Hospital, Prague","startDate":"2022-07-02","conditions":"Non-Alcoholic Fatty Liver Disease","enrollment":20},{"nctId":"NCT02609048","phase":"PHASE2","title":"Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2015-11-04","conditions":"Primary Biliary Cirrhosis (PBC)","enrollment":41},{"nctId":"NCT06842472","phase":"PHASE2","title":"PD-L1 Inhibitor + RT ± Ursodeoxycholic Acid in Recurrent/Metastatic HER2-Neg Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2025-02","conditions":"Breast Cancer","enrollment":70},{"nctId":"NCT05659654","phase":"PHASE1, PHASE2","title":"The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)","status":"COMPLETED","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2022-12-16","conditions":"COVID-19","enrollment":95},{"nctId":"NCT06715319","phase":"PHASE3","title":"Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","startDate":"2021-10-09","conditions":"PBC","enrollment":100},{"nctId":"NCT05925309","phase":"NA","title":"Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy","status":"RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2023-07-01","conditions":"Biliary Atresia, Cholangitis, Anti-Bacterial Agents","enrollment":356},{"nctId":"NCT06629909","phase":"PHASE1","title":"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","status":"NOT_YET_RECRUITING","sponsor":"Baermed","startDate":"2024-12-01","conditions":"Liver Cirrhosis","enrollment":54},{"nctId":"NCT04620733","phase":"PHASE3","title":"RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2021-04-21","conditions":"Primary Biliary Cholangitis","enrollment":193},{"nctId":"NCT00909610","phase":"PHASE1","title":"Ursodiol Tablets 500 mg Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2006-12","conditions":"Healthy","enrollment":80},{"nctId":"NCT00909753","phase":"PHASE1","title":"Ursodiol 500 mg Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2006-09","conditions":"Healthy","enrollment":92},{"nctId":"NCT03004118","phase":"PHASE4","title":"Therapeutic Effect of Ursodeoxycholic Acid in Functional Dyspepsia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2017-01","conditions":"Functional Dyspepsia","enrollment":16},{"nctId":"NCT05410535","phase":"PHASE4","title":"To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2021-09-15","conditions":"Gastric Cancer","enrollment":431},{"nctId":"NCT06278090","phase":"","title":"Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution","status":"RECRUITING","sponsor":"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","startDate":"2024-03-01","conditions":"Gallbladder Polyp","enrollment":36},{"nctId":"NCT05973370","phase":"PHASE2","title":"Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Tanta University","startDate":"2023-05-01","conditions":"Rheumatoid Arthritis","enrollment":60},{"nctId":"NCT06411275","phase":"PHASE2","title":"A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise","status":"COMPLETED","sponsor":"HighTide Biopharma Pty Ltd","startDate":"2022-03-31","conditions":"Type 2 Diabetes Mellitus","enrollment":113},{"nctId":"NCT05526807","phase":"NA","title":"Ursodeoxycholic Acid in C. Difficile Infection","status":"TERMINATED","sponsor":"Nottingham University Hospitals NHS Trust","startDate":"2019-05-08","conditions":"Clostridioides Difficile Infection","enrollment":6},{"nctId":"NCT06309589","phase":"NA","title":"The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis","status":"COMPLETED","sponsor":"Yilihamu·Abilitifu","startDate":"2021-05-01","conditions":"Primary Biliary Cholangitis","enrollment":60},{"nctId":"NCT06287931","phase":"NA","title":"Probiotics for Gallstones in Post-bariatric Surgery Patients","status":"UNKNOWN","sponsor":"Shandong Linglong Yingcheng Hospital","startDate":"2024-01-01","conditions":"Bariatric Surgery Candidate, Gallstone, Gallstone Attack","enrollment":400},{"nctId":"NCT01505569","phase":"NA","title":"Auto Transplant for High Risk or Relapsed Solid or CNS Tumors","status":"COMPLETED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2011-10-20","conditions":"Ewing's Family Tumors, Renal Tumors, Hepatoblastoma","enrollment":44},{"nctId":"NCT03954327","phase":"PHASE2","title":"Combination Antiretroviral Therapy (cART) for PBC","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2021-03-01","conditions":"Primary Biliary Cholangitis","enrollment":37},{"nctId":"NCT00550862","phase":"PHASE2","title":"Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2007-10","conditions":"Liver Cirrhosis, Biliary","enrollment":165},{"nctId":"NCT06127355","phase":"PHASE3","title":"Gestational Treatment With Ursodeoxycholic Acid Compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus Diagnosed at 24-28 Weeks' Gestation","status":"COMPLETED","sponsor":"Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia","startDate":"2021-03-03","conditions":"Gestational Diabetes","enrollment":113},{"nctId":"NCT05904067","phase":"NA","title":"A Study to Evaluate the Safety and Efficacy of COVID-19 Convalescent Plasma (CCP) Transfusion to Prevent COVID-19 in Adult Recipients Following Hematopoietic Stem Cell Transplantation","status":"UNKNOWN","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2023-06-10","conditions":"COVID-19, Hematopoietic Stem Cell Transplantation","enrollment":72},{"nctId":"NCT05902468","phase":"PHASE2, PHASE3","title":"Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2023-06-28","conditions":"Diabetes Mellitus, Type 2","enrollment":88},{"nctId":"NCT03602976","phase":"PHASE2","title":"Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis","status":"TERMINATED","sponsor":"Ethan Weinberg","startDate":"2018-08-20","conditions":"Hepatic Sarcoidosis, Elevated Alkaline Phosphatase","enrollment":7},{"nctId":"NCT04076527","phase":"","title":"Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis","status":"UNKNOWN","sponsor":"University of Leipzig","startDate":"2019-09-19","conditions":"PBC, Primary Biliary Cholangitis","enrollment":1200},{"nctId":"NCT05416580","phase":"PHASE3","title":"Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes","status":"UNKNOWN","sponsor":"University of Banja Luka","startDate":"2022-09-12","conditions":"Diabetes Mellitus, Type 2","enrollment":60},{"nctId":"NCT05849558","phase":"PHASE4","title":"Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients","status":"UNKNOWN","sponsor":"MinaPharm Pharmaceuticals","startDate":"2022-02-22","conditions":"Chronic Liver Disease","enrollment":297},{"nctId":"NCT05832697","phase":"PHASE1","title":"An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2022-01-27","conditions":"Healthy Subject","enrollment":44},{"nctId":"NCT05812612","phase":"","title":"UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease","status":"UNKNOWN","sponsor":"Beijing Ditan Hospital","startDate":"2023-01-30","conditions":"COVID-19 Infection","enrollment":2000},{"nctId":"NCT05690646","phase":"PHASE4","title":"Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery","status":"UNKNOWN","sponsor":"China National Center for Cardiovascular Diseases","startDate":"2023-01-28","conditions":"Cardiac Surgery","enrollment":491},{"nctId":"NCT04834557","phase":"PHASE2","title":"Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Tanta University","startDate":"2021-11-01","conditions":"Rheumatoid Arthritis","enrollment":90},{"nctId":"NCT02823353","phase":"PHASE3","title":"Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2016-04-08","conditions":"Primary Biliary Cirrhosis","enrollment":117},{"nctId":"NCT01654731","phase":"PHASE3","title":"Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2012-10-15","conditions":"PBC","enrollment":100},{"nctId":"NCT04542473","phase":"PHASE2, PHASE3","title":"Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children","status":"UNKNOWN","sponsor":"University of Oxford","startDate":"2021-07-01","conditions":"SEPSIS, MALNUTRITION, CHILD","enrollment":400},{"nctId":"NCT03266146","phase":"PHASE1, PHASE2","title":"36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent DILI","status":"COMPLETED","sponsor":"Beijing 302 Hospital","startDate":"2017-09-02","conditions":"Drug-induced Liver Injury,Chronic","enrollment":90},{"nctId":"NCT04531878","phase":"PHASE2, PHASE3","title":"BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases","status":"WITHDRAWN","sponsor":"Children's Hospital of Fudan University","startDate":"2023-02-08","conditions":"Hereditary Diseases, Cholestasis, Intrahepatic","enrollment":""},{"nctId":"NCT05685888","phase":"","title":"Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation","status":"COMPLETED","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2015-01-01","conditions":"Organ Transplantation, COVID-19","enrollment":2000},{"nctId":"NCT05467553","phase":"PHASE2","title":"A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2023-02-24","conditions":"Hepatitis D","enrollment":30},{"nctId":"NCT04910178","phase":"PHASE4","title":"Follow-up of NAFLD Patients With MRI-PDFF","status":"COMPLETED","sponsor":"Asmaa Abdelfattah Elsayed","startDate":"2020-12-01","conditions":"Diabetes Type 2, NAFLD","enrollment":80},{"nctId":"NCT04810156","phase":"PHASE2","title":"Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis","status":"UNKNOWN","sponsor":"Inge Marie Svane","startDate":"2021-04-07","conditions":"Hepatitis, Drug-Induced","enrollment":60},{"nctId":"NCT02823366","phase":"PHASE3","title":"Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid","status":"UNKNOWN","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2016-01","conditions":"Primary Biliary Cirrhosis","enrollment":104},{"nctId":"NCT05500937","phase":"PHASE2, PHASE3","title":"Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2021-03-01","conditions":"Diabetes Mellitus","enrollment":1000},{"nctId":"NCT01865812","phase":"PHASE2","title":"Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2013-12-03","conditions":"Primary Biliary Cirrhosis","enrollment":27},{"nctId":"NCT03602560","phase":"PHASE3","title":"ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2018-10-01","conditions":"Primary Biliary Cholangitis","enrollment":265},{"nctId":"NCT02955602","phase":"PHASE2","title":"Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-11-28","conditions":"Primary Biliary Cirrhosis","enrollment":119},{"nctId":"NCT03226067","phase":"PHASE2","title":"Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.","status":"COMPLETED","sponsor":"Calliditas Therapeutics AB","startDate":"2017-06-26","conditions":"Primary Biliary Cirrhosis","enrollment":111},{"nctId":"NCT04309773","phase":"PHASE3","title":"Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-04-06","conditions":"Primary Sclerosing Cholangitis, Cholestasis","enrollment":104},{"nctId":"NCT02967250","phase":"PHASE1","title":"Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2020-04-01","conditions":"Parkinson Disease","enrollment":5},{"nctId":"NCT03844100","phase":"PHASE1, PHASE2","title":"Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients","status":"COMPLETED","sponsor":"Gangnam Severance Hospital","startDate":"2019-11-01","conditions":"Dyspepsia, Biliary Dysplasia","enrollment":37}],"_emaApprovals":[],"_faersSignals":[{"count":419,"reaction":"OFF LABEL USE"},{"count":353,"reaction":"PYREXIA"},{"count":269,"reaction":"DIARRHOEA"},{"count":225,"reaction":"DRUG INEFFECTIVE"},{"count":215,"reaction":"HEPATIC FUNCTION ABNORMAL"},{"count":203,"reaction":"ANAEMIA"},{"count":203,"reaction":"PNEUMONIA"},{"count":190,"reaction":"NAUSEA"},{"count":183,"reaction":"PLATELET COUNT DECREASED"},{"count":182,"reaction":"DECREASED APPETITE"}],"_approvalHistory":[],"publicationCount":6196,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["UDCAMENT","UDCA","Ursofalk","Ursolit","Ursodiol"],"phase":"marketed","status":"active","brandName":"Ursodeoxycholic acid","genericName":"Ursodeoxycholic acid","companyName":"University of Oxford","companyId":"university-of-oxford","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and increases bile flow to improve hepatic function and reduce cholestasis. Used for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Gallstone dissolution.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":6,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}