Ursodeoxycholic Acid

Phase 3Small molecule

Daewoong Pharmaceutical Co. LTD.

Ursodeoxycholic Acid is one of 205 small molecule programs targeting Chronic Liver Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

204

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Liver DiseaseNot yet recruiting

Liver TransplantActive, not recruiting

Impaired Glucose ToleranceActive, not recruiting

FibrosisActive, not recruiting

EncephalopathyActive, not recruiting

Non-Alcoholic SteatohepatitisActive, not recruiting

HyperlipidemiaRecruiting

Bladder Urothelial CarcinomaRecruiting

Breast CancerNot yet recruiting

Gestational DiabetesActive, not recruiting

Chronic Liver DiseasePreclinical

Not yet recruiting

Liver TransplantPreclinical

Active, not recruiting

Impaired Glucose TolerancePreclinical

Active, not recruiting

FibrosisPreclinical

Active, not recruiting

EncephalopathyPreclinical

Active, not recruiting

Non-Alcoholic SteatohepatitisPreclinical

Active, not recruiting

HyperlipidemiaPreclinical

Recruiting

Bladder Urothelial CarcinomaPhase 2

Recruiting

Breast CancerPhase 2

Not yet recruiting

Gestational DiabetesPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ursodeoxycholic Acid

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 2

Rilvegostomig

AstraZeneca

Preclinical

1 3

Ablavar

LLantheus Medical Imaging

Preclinical

2 4

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 5

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 6

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 7

Lapatinib Plus Capecitabine

GSK

Preclinical

2 8

Ibrance

Pfizer

Preclinical

1 9

Fluorothymidine F-18

MM.D. Anderson Cancer Center

Preclinical

1 10

Determination of ESR1 Mutations

CCentre Henri Becquerel

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Gastric Intestinal Metaplasia

NCT06610760

Q1 2027

N/ARecruiting

Hyperbilirubinemia

NCT07110987

Q2 2027

PreclinicalRecruiting

Hyperlipidemia

NCT06684106

Q3 2027

Phase 3Recruiting

Acute Pancreatitis

NCT04924868

N/ARecruiting

Hyperbilirubinemia

NCT06922669

Clinical

Trials by Indication[1]

Primary Biliary Cirrhosis5 trials

Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis

Unknown status·—·Phase 1·NCT01440309·20 enrolled

Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT02937012·34 enrolled

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus

Completed· GSK logo

GSK·Phase 2·NCT01899703·22 enrolled

Show 2 more trials

Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

Completed·MMirum Pharmaceuticals, Inc.·Phase 2·NCT01904058·66 enrolled

Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Completed·—·Phase 3·NCT01857284·216 enrolled

Primary Biliary Cholangitis4 trials

Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid

Completed·HHumanity and Health Research Centre··NCT03188146·57 enrolled

Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

Completed·—·N/A·NCT03665519·40 enrolled

Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Unknown status·XXiaoli Fan·N/A·NCT02936596·53 enrolled

Show 1 more trial

A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

Unknown status·IInstituto Mexicano del Seguro Social·Phase 3·NCT04751188·11 enrolled

Cholestasis3 trials

Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02420496

Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Withdrawn·UUniversity of Bologna·Phase 3·NCT01226823

Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Unknown status·WWei Liu·N/A·NCT05043194·80 enrolled

Non-Alcoholic Steatohepatitis2 trials

Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients

Completed·KKafrelsheikh University·Phase 4·NCT04977661·102 enrolled

Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis

Completed·—·N/A·NCT03664596·80 enrolled

Familial adenomatous polyposis2 trials

Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT00134758·90 enrolled

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Completed·RRadboud University Medical Center·Phase 2/3·NCT00808743·37 enrolled

51 more indications

Intrahepatic Cholestasis2 trials

Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Completed·TTurku University Hospital·Phase 3·NCT01576458·20 enrolled

Metformin in Intrahepatic Cholestasis of Pregnancy

Unknown status·—·Phase 2/3·NCT03056274·40 enrolled

Infection2 trials

Ursodeoxycholic Acid in C. Difficile Infection

Terminated·NNottingham University Hospitals NHS Trust·N/A·NCT05526807·6 enrolled

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT05467553·30 enrolled

Liver Disease2 trials

UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease

Unknown status·—··NCT05812612·2,000 enrolled

Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease

Completed·RRadboud University Medical Center·Phase 2·NCT02021110·34 enrolled

Clinical Trial2 trials

Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

Unknown status·SSeoul National University Hospital·Phase 1·NCT02789644·16 enrolled

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

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT05832697·44 enrolled

Sclerosing Cholangitis2 trials

Trial of High-dose Urso in Primary Sclerosing Cholangitis

Terminated·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2/3·NCT00059202·150 enrolled

Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis

Completed·UUniversity of Tennessee·Phase 1·NCT01088607·27 enrolled

Hyperbilirubinemia2 trials

The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia

Recruiting·TTishreen University Hospital·N/A·NCT07110987·70 enrolled

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

Recruiting·GGeneral Hospital of Shenyang Military Region·N/A·NCT06922669·232 enrolled

Rheumatoid Arthritis2 trials

Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

Completed·TTanta University·Phase 2·NCT04834557·90 enrolled

Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

Completed·TTanta University·Phase 2·NCT05973370·60 enrolled

Complete Response1 trial

Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

Recruiting·PPeking Union Medical College Hospital·Phase 4·NCT04650243·90 enrolled

Pancreatic1 trial

Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

Unknown status·UUniversity of Oxford·Phase 2/3·NCT04542473·400 enrolled

Hepatitis1 trial

Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

Unknown status·IInge Marie Svane·Phase 2·NCT04810156·60 enrolled

Acute Pancreatitis1 trial

Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis

Recruiting·—·Phase 3·NCT04924868·332 enrolled

Sarcoidosis1 trial

Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis

Terminated·EEthan Weinberg·Phase 2·NCT03602976·7 enrolled

Short Bowel Syndrome1 trial

The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients

Completed·JJinling Hospital, China·Phase 4·NCT01974336·30 enrolled

Toxicity1 trial

Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity

Completed·UUniversity of Magdeburg·Phase 2·NCT01149304·22 enrolled

Amyloidosis1 trial

Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis

Completed·UUmeå University·Phase 2·NCT02016365·55 enrolled

NAFLD1 trial

Follow-up of NAFLD Patients With MRI-PDFF

Completed·AAsmaa Abdelfattah Elsayed·Phase 4·NCT04910178·80 enrolled

Heart Failure1 trial

Ursodeoxycholic Acid in Chronic Heart Failure

Unknown status·NNational Heart and Lung Institute·Phase 2·NCT00285597

Gastric Intestinal Metaplasia1 trial

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Recruiting·YYongquan Shi·Phase 4·NCT06610760·196 enrolled

Drug-Induced Liver Injury1 trial

Cholestatic Drug-induced Liver Injury

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01141322·180 enrolled

Type 2 Diabetes Mellitus1 trial

Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus

Unknown status·TTanta University·Phase 2/3·NCT05902468·88 enrolled

Effectiveness1 trial

Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

Unknown status·—·Phase 3·NCT02721862·100 enrolled

Fibrosis1 trial

Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

Completed·ZZagazig University·N/A·NCT03659058·400 enrolled

Humans1 trial

Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans

Terminated·VVanderbilt University Medical Center·Phase 1·NCT03201952·2 enrolled

Hepatectomy1 trial

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06091787·90 enrolled

Overweight1 trial

Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems

Unknown status·SSeoul National University Hospital·Phase 1·NCT03000218·30 enrolled

Cholestatic liver disease1 trial

Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC

Completed·BBeijing Trendful Kangjian Medical Information Consulting Limited Company·Phase 3·NCT01829698·199 enrolled

Peritoneal Dialysis1 trial

Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis

Unknown status·EEwha Womans University·Phase 4·NCT02338635·55 enrolled

Rhegmatogenous Retinal Detachment1 trial

Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment

Completed·FFrancine Behar-Cohen·Phase 1·NCT02841306·26 enrolled

Gestational Diabetes1 trial

Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

Active, not recruiting·KKing's College London·Phase 4·NCT04407650·64 enrolled

Gastric1 trial

Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Completed·HHvidovre University Hospital·Phase 4·NCT02340247·11 enrolled

Glucocorticoid1 trial

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

Unknown status·WWest China Hospital·Phase 4·NCT04617561·90 enrolled

Parkinson's Disease1 trial

Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment

Completed·UUniversity of Minnesota·Phase 1·NCT02967250·5 enrolled

Liver Transplant1 trial

Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

Completed·SShanghai Jiao Tong University School of Medicine·N/A·NCT01073202·112 enrolled

Obstructive Jaundice1 trial

The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice

Unknown status·UUniversity Clinical Centre of Kosova·Phase 2·NCT01688375·54 enrolled

COVID-191 trial

The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT05659654·95 enrolled

Treatment1 trial

Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects

Unknown status·SSVS Institute of Dental Sciences·N/A·NCT04937023·26 enrolled

Cirrhosis1 trial

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

Terminated·IIntercept Pharmaceuticals·Phase 2·NCT00550862·165 enrolled

Breast Cancer1 trial

PD-L1 Inhibitor + RT ± Ursodeoxycholic Acid in Recurrent/Metastatic HER2-Neg Breast Cancer

Not yet recruiting·—·Phase 2·NCT06842472·70 enrolled

Encephalopathy1 trial

UDCA to Prevent Post-TIPS Hepatic Encephalopathy

Not yet recruiting·WWest China Hospital·N/A·NCT07273734·270 enrolled

High Risk1 trial

Hepatoprotective Measures for Children at High Risk of NAFLD

Active, not recruiting·—·Phase 4·NCT06918080·200 enrolled

Bariatric Surgery1 trial

Ursodeoxycholic Acid in Bariatric Surgery

Completed·SSahlgrenska University Hospital·N/A·NCT01548079·40 enrolled

Acute Lymphoblastic Leukemia1 trial

UDCA for Symptomatic Gallstone Disease

Completed·UUMC Utrecht·Phase 4·NCT00161083·180 enrolled

Barrett's esophagus1 trial

Clinical Studies on Bile Acids in Barrett's Esophagus

Completed·UUS Department of Veterans Affairs·N/A·NCT00858858·60 enrolled

Tic Disorder1 trial

The Role of Ursodeoxycholic Acid in Treatment of Gallstones in Hemolytic Disorders

Terminated·SShaare Zedek Medical Center·Phase 4·NCT02472509·3 enrolled

Neonatal1 trial

Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia

Completed·AAmira Adel Fouly·Approved·NCT06517862·140 enrolled

Primary Sclerosing Cholangitis1 trial

A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)

Withdrawn·HHighTide Biopharma Pty Ltd·Phase 2·NCT03678480

Liver Fibrosis1 trial

Remedial Mechanisms of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk Between Bile Secretion, Gut Microbiome, and Host Immune Response

Terminated·CChang Gung Memorial Hospital·Preclinical·NCT07102979·19 enrolled

Bladder Urothelial Carcinoma1 trial

Study on Immunotherapy Enhancement Strategies for Muscle-invasive Bladder Cancer

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT07717242·80 enrolled

Hyperlipidemia1 trial

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial

Recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·Preclinical·NCT06684106·128 enrolled

Chronic Liver Disease1 trial

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·Preclinical·NCT07664020·130 enrolled

Unspecified3 trials

A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT02622685·58 enrolled

Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

Completed·UUniversity of Sao Paulo General Hospital·N/A·NCT03489889·30 enrolled

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial

Completed·CChina National Center for Cardiovascular Diseases·Approved·NCT05690646·491 enrolled

Sources

References

[1]
ClinicalTrials.gov — 76 trial records for Ursodeoxycholic Acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ursodeoxycholic Acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ursodeoxycholic Acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Daewoong Pharmaceutical Co. LTD. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Daewoong Pharmaceutical Co. LTD.

Ursodeoxycholic Acid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Primary Biliary Cirrhosis5 trials

Primary Biliary Cholangitis4 trials

Cholestasis3 trials

Non-Alcoholic Steatohepatitis2 trials

Familial adenomatous polyposis2 trials

Intrahepatic Cholestasis2 trials

Infection2 trials

Liver Disease2 trials

Clinical Trial2 trials

Sclerosing Cholangitis2 trials

Hyperbilirubinemia2 trials

Rheumatoid Arthritis2 trials

Complete Response1 trial

Pancreatic1 trial

Hepatitis1 trial

Acute Pancreatitis1 trial

Sarcoidosis1 trial

Short Bowel Syndrome1 trial

Toxicity1 trial

Amyloidosis1 trial

NAFLD1 trial

Heart Failure1 trial

Gastric Intestinal Metaplasia1 trial

Drug-Induced Liver Injury1 trial

Type 2 Diabetes Mellitus1 trial

Effectiveness1 trial

Fibrosis1 trial

Humans1 trial

Hepatectomy1 trial

Overweight1 trial

Cholestatic liver disease1 trial

Peritoneal Dialysis1 trial

Rhegmatogenous Retinal Detachment1 trial

Gestational Diabetes1 trial

Gastric1 trial

Glucocorticoid1 trial

Parkinson's Disease1 trial

Liver Transplant1 trial

Obstructive Jaundice1 trial

COVID-191 trial

Treatment1 trial

Cirrhosis1 trial

Breast Cancer1 trial

Encephalopathy1 trial

High Risk1 trial

Bariatric Surgery1 trial

Acute Lymphoblastic Leukemia1 trial

Barrett's esophagus1 trial

Tic Disorder1 trial

Neonatal1 trial

Primary Sclerosing Cholangitis1 trial

Liver Fibrosis1 trial

Bladder Urothelial Carcinoma1 trial

Hyperlipidemia1 trial

Chronic Liver Disease1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

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