Ursodeoxycholic acid

Generic Name: Ursodeoxycholic acid

Brand Names: Reltone, Urso, Urso Forte

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₄₀O_₄

CAS Number: 128-13-2

Unique Ingredient Identifier: 724L30Y2QR

Background: Ursodeoxycholic acid (UDCA), also known as ursodiol, is a naturally-occurring bile acid that constitutes a minor fraction of the human bile acid pool. UDCA has been used to treat liver disease for decades: its first use in traditional medicine dates back more than a hundred years. UDCA was first characterized in the bile of the Chinese black bear and is form...

Indication: Ursodeoxycholic acid is indicated for the treatment of patients with primary biliary cholangitis.

It is used for the short-term treatment of radiolucent, noncalcified gallbladder stones in patients selected for elective cholecystectomy. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.

Associated Conditions: Gallstones, Primary Biliary Cholangitis

Associated Therapies: -

Clinical Trials

Comparative Bioavailability Study of UDCA

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ursodiol
Drug: URSO Forte

First Posted Date: 2015-03-11

Last Posted Date: 2015-05-07

Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Target Recruit Count: 50

Registration Number: NCT02385032

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

Phase 4

Completed

Conditions: Severe Obesity

Interventions: Other: Water
Drug: Ursodeoxycholic Acid
Drug: Chenodeoxycholic Acid

First Posted Date: 2015-01-16

Last Posted Date: 2016-06-30

Lead Sponsor: Hvidovre University Hospital

Target Recruit Count: 11

Registration Number: NCT02340247

Locations: 🇩🇰
Hvidovre University Hospital, Hvidovre, Denmark

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

Phase 4

Conditions: End-Stage Kidney Disease

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2015-01-14

Last Posted Date: 2015-05-15

Lead Sponsor: Ewha Womans University

Target Recruit Count: 55

Registration Number: NCT02338635

Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

Not Applicable

Conditions: Morbid Obesity

Interventions: Drug: URSODIOL
Drug: Placebo

First Posted Date: 2014-12-18

Last Posted Date: 2018-05-17

Lead Sponsor: HaEmek Medical Center, Israel

Target Recruit Count: 266

Registration Number: NCT02319629

Locations: 🇮🇱
surgery department A, Afula, Israel

Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ursodiol

First Posted Date: 2014-01-13

Last Posted Date: 2019-05-08

Lead Sponsor: Mayo Clinic

Target Recruit Count: 24

Registration Number: NCT02033876

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease

Phase 2

Completed

Conditions: Polycystic Liver Disease
Polycystic Kidney, Autosomal Dominant

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2013-12-27

Last Posted Date: 2021-09-23

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 34

Registration Number: NCT02021110

Locations: 🇳🇱
Radboud University Medical Centre Nijmegen, Nijmegen, Gelderland, Netherlands
🇪🇸
Donostia University Hospital, San Sebastian, Spain
🇳🇱
Academic Medical Centre Amsterdam, Amsterdam, Netherlands

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

Phase 2

Completed

Conditions: Transthyretin Amyloidosis
Cardiomyopathy

Interventions: Drug: Doxycycline
Drug: Ursodeoxycholic acid

First Posted Date: 2013-12-20

Last Posted Date: 2016-05-12

Lead Sponsor: Umeå University

Target Recruit Count: 55

Registration Number: NCT02016365

Locations: 🇸🇪
Dept of Clinical Medicin, Ptieå Hospital, Piteå, Sweden
🇸🇪
Dept of clinical medicin, Skellefteå Hospital, Skellefteå, Sweden
🇸🇪
Dept of Clinical Medicine, Umeå University Hospital, Umeå, Sweden

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

Phase 4

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: ursodeoxycholic acid

First Posted Date: 2013-11-01

Last Posted Date: 2017-02-24

Lead Sponsor: Jinling Hospital, China

Target Recruit Count: 30

Registration Number: NCT01974336

Locations: 🇨🇳
Jinling Hospital, Nanjing, Jiangsu, China

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

Phase 2

Completed

Conditions: Primary Biliary Cirrhosis
PBC

Interventions: Drug: Placebo
Drug: LUM001
Drug: Ursodeoxycholic Acid

First Posted Date: 2013-07-22

Last Posted Date: 2019-03-27

Lead Sponsor: Mirum Pharmaceuticals, Inc.

Target Recruit Count: 66

Registration Number: NCT01904058

Locations: 🇺🇸
Minnesota Gastroenterology, Saint Paul, Minnesota, United States
🇺🇸
Henry Ford Health System, Detroit, Michigan, United States
🇺🇸
Scripps Clinic, La Jolla, California, United States

and more 21 locations

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

Phase 2

Completed

Conditions: Cholestasis, Intrahepatic

Interventions: Drug: GSK2330672
Drug: Placebo
Drug: Ursodeoxycholic acid

First Posted Date: 2013-07-15

Last Posted Date: 2017-08-01

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 22

Registration Number: NCT01899703

Locations: 🇬🇧
GSK Investigational Site, Newcastle upon Tyne, United Kingdom

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