Ursodeoxycholic acid
- Generic Name
- Ursodeoxycholic acid
- Brand Names
- Reltone, Urso, Urso Forte
- Drug Type
- Small Molecule
- Chemical Formula
- C24H40O4
- 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 formed by 7b-epimerization of chenodeoxycholic acid, which is a primary bile acid. Due to its hydrophilicity, UDCA is less toxic than cholic acid or chenodeoxycholic acid.
UDCA was first approved by the FDA in 1987 for dissolution of gallstones and for primary biliary cirrhosis in 1996. UDCA works by replacing the hydrophobic or more toxic bile acids from the bile acid pool.
- 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
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
- Conditions
- Hepatitis, AutoimmunePrimary Biliary Cholangitis
- Interventions
- Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
- First Posted Date
- 2020-11-05
- Last Posted Date
- 2021-03-22
- Lead Sponsor
- West China Hospital
- Target Recruit Count
- 90
- Registration Number
- NCT04617561
- Locations
- 🇨🇳
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University, Chengdu, Sichuan, China
Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children
- Conditions
- MALNUTRITION, CHILDSEPSIS
- Interventions
- Other: Pancreatic Enzyme placeboOther: Ursodeoxycholic acid placeboDrug: Pancreatic Enzyme
- First Posted Date
- 2020-09-09
- Last Posted Date
- 2023-02-24
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 400
- Registration Number
- NCT04542473
- Locations
- 🇺🇬
Mulago Hospital, Kampala, Uganda
🇲🇼Queen Elizabeth Central Hospital, Blantyre, Malawi
🇰🇪KEMRI WT Clinical Trials Facility, Kilifi, Kenya
Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
- First Posted Date
- 2020-07-20
- Last Posted Date
- 2020-07-29
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Target Recruit Count
- 28
- Registration Number
- NCT04477369
- Locations
- 🇰🇷
Kyung Hee University Medical Hospital, Seoul, Korea, Republic of
Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus
- Conditions
- Gestational Diabetes
- Interventions
- First Posted Date
- 2020-05-29
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- King's College London
- Target Recruit Count
- 64
- Registration Number
- NCT04407650
- Locations
- 🇬🇧
Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives
- Conditions
- Cholestasis of Pregnancy
- Interventions
- First Posted Date
- 2020-02-24
- Last Posted Date
- 2021-09-02
- Lead Sponsor
- Alexandra Hospital, Athens, Greece
- Target Recruit Count
- 50
- Registration Number
- NCT04281082
- Locations
- 🇬🇷
Alexandra General Hospital, Athens, Greece
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
- First Posted Date
- 2019-09-03
- Last Posted Date
- 2023-06-07
- Lead Sponsor
- University of Leipzig
- Target Recruit Count
- 1200
- Registration Number
- NCT04076527
- Locations
- 🇩🇪
Charité-Campus Virchow-Klinikum, Berlin, Germany
🇩🇪University Hospital Aachen, Aachen, Germany
🇩🇪Charité - Campus Benjamin Franklin, Berlin, Germany
The Role of Secondary Bile Acids in Intestinal Inflammation
- Conditions
- Ulcerative ColitisPouchitis
- Interventions
- First Posted Date
- 2018-10-30
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 15
- Registration Number
- NCT03724175
- Locations
- 🇺🇸
Stanford University, Stanford, California, United States
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
- Conditions
- Primary Sclerosing CholangitisCholangitisCholangitis, SclerosingBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesAdolescent
- Interventions
- First Posted Date
- 2018-09-19
- Last Posted Date
- 2021-02-15
- Lead Sponsor
- HighTide Biopharma Pty Ltd
- Registration Number
- NCT03678480
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- Dietary Supplement: Sublimated mare milk
- First Posted Date
- 2018-09-11
- Last Posted Date
- 2021-01-26
- Lead Sponsor
- National Scientific Medical Center, Kazakhstan
- Target Recruit Count
- 40
- Registration Number
- NCT03665519
- Locations
- 🇰🇿
National Research Medical Center, Astana, Kazakhstan
Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis
- Conditions
- Non-alcoholic Steatohepatitis
- Interventions
- Dietary Supplement: Sublimated mare's milk
- First Posted Date
- 2018-09-10
- Last Posted Date
- 2021-02-05
- Lead Sponsor
- Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
- Target Recruit Count
- 80
- Registration Number
- NCT03664596
- Locations
- 🇰🇿
Medical Centre Hospital of the President's Affairs Administration, Astana, Kazakhstan
Drug Development Updates
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