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
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
- Conditions
- Drug Induced Liver Injury
- Interventions
- Procedure: Plaslna exchangeProcedure: Liver transplantation
- First Posted Date
- 2025-04-10
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- General Hospital of Shenyang Military Region
- Target Recruit Count
- 232
- Registration Number
- NCT06922669
- Locations
- 🇨🇳
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area), Shenyang, Liaoning, China
Prevention of Recurrence of Clostridioides Difficile Colitis with Ursodeoxycholic Acid (UCDA) As a Supplement to Standard Therapy
- Conditions
- Clostridioides Difficile Infection
- Interventions
- First Posted Date
- 2025-03-19
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 30
- Registration Number
- NCT06884748
- Locations
- 🇺🇸
Daniel Stein, Milwaukee, Wisconsin, United States
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis
- First Posted Date
- 2024-12-04
- Last Posted Date
- 2024-12-04
- Target Recruit Count
- 100
- Registration Number
- NCT06715319
- Locations
- 🇨🇳
The First Hospital of Jilin University, Changchun, Jilin, China
Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Placebo, Randomized Controlled Trial
- Conditions
- Gastric Intestinal Metaplasia
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-09-24
- Last Posted Date
- 2024-09-24
- Lead Sponsor
- Yongquan Shi
- Target Recruit Count
- 196
- Registration Number
- NCT06610760
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
- Conditions
- Primary Biliary Cholangitis (PBC)
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Han Ying
- Target Recruit Count
- 30
- Registration Number
- NCT06591455
- Locations
- 🇨🇳
Xijing hospital, Xi'an, Shaanxi, China
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
- Conditions
- Primary Biliary Cholangitis (PBC)
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Han Ying
- Target Recruit Count
- 244
- Registration Number
- NCT06591468
- Locations
- 🇨🇳
Xijing hospital, Xi'an, Shaanxi, China
Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
- Conditions
- Neonatal Hyperbilirubinemia
- Interventions
- First Posted Date
- 2024-07-24
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Amira Adel Fouly
- Target Recruit Count
- 80
- Registration Number
- NCT06517862
- Locations
- 🇪🇬
Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals, Cairo, Egypt
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
- First Posted Date
- 2024-04-15
- Last Posted Date
- 2024-04-15
- Lead Sponsor
- Xijing Hospital of Digestive Diseases
- Target Recruit Count
- 117
- Registration Number
- NCT06365424
- Locations
- 🇨🇳
Xijing Hospital, Xi'an, Shaanxi, China
Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
- First Posted Date
- 2024-02-22
- Last Posted Date
- 2024-12-30
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Target Recruit Count
- 263
- Registration Number
- NCT06272630
- Locations
- 🇰🇷
SoonChunHyang University Seoul Hospital, Seoul, Korea, Republic of
Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis
- Conditions
- Primary Biliary Cholangitis
- Interventions
- First Posted Date
- 2023-12-18
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Han Ying
- Target Recruit Count
- 184
- Registration Number
- NCT06174402
- Locations
- 🇨🇳
The second hospital of Lanzhou University, Lanzhou, Gansu, China
🇨🇳Jiangsu Province Hospital, Nanjing, Jiangsu, China
🇨🇳Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Drug Development Updates
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