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 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

Clinical Trials

Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

Phase 3

Completed

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Obeticholic Acid Tablets（OCA）
Drug: UDCA
Drug: Placebo

First Posted Date: 2022-07-11

Last Posted Date: 2024-07-11

Lead Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

Target Recruit Count: 108

Registration Number: NCT05450887

Locations: 🇨🇳
Beijing Friendship Hospital, Beijing, China

Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes

Phase 3

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: UDCA (Ursodeoxycholic acid)
Drug: Metformin

First Posted Date: 2022-06-13

Last Posted Date: 2023-05-11

Lead Sponsor: University of Banja Luka

Target Recruit Count: 60

Registration Number: NCT05416580

Locations: 🇧🇦
Public Health Institution Dom zdravlja Banja Luka, Banja Luka, Republic Of Srpska, Bosnia and Herzegovina

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

Phase 4

Completed

Conditions: Nonalcoholic Steatohepatitis (NASH)

Interventions: Drug: Vitamin E
Drug: Ursodeoxycholic acid
Drug: Pentoxifylline

First Posted Date: 2021-07-27

Last Posted Date: 2021-07-27

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 102

Registration Number: NCT04977661

Locations: 🇪🇬
Hepatology, gastroenterology and infectious diseases department at Kafrelsheikh University Hospital, Cairo, Egypt

Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Obeticholic Acid Tablets
Drug: UDCA
Drug: Placebo

First Posted Date: 2021-07-09

Last Posted Date: 2021-07-26

Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Target Recruit Count: 120

Registration Number: NCT04956328

Locations: 🇨🇳
The first hospital of Jilin University, Changchun, Jilin, China

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

Not Applicable

Conditions: Bone Regeneration

Interventions: Drug: Ursodeoxycholic acid gel

First Posted Date: 2021-06-23

Last Posted Date: 2021-06-23

Lead Sponsor: SVS Institute of Dental Sciences

Target Recruit Count: 26

Registration Number: NCT04937023

Locations: 🇮🇳
SVS Institute of Dental Sciences, Hyderabad, Telangana, India

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

Phase 3

Recruiting

Conditions: Acute Pancreatitis Due to Gallstones

Interventions: Drug: Ursodeoxycholic Acid
Drug: Placebo

First Posted Date: 2021-06-14

Last Posted Date: 2025-03-20

Lead Sponsor: Hospital General Universitario de Alicante

Target Recruit Count: 332

Registration Number: NCT04924868

Locations: 🇪🇸
Hospital Ramon y Cajal, Madrid, Spain
🇪🇸
Hospital Clínico Universitario de Santiago, Santiago De Compostela, A coruña, Spain
🇪🇸
Hospital General Universitario de Elche, Elche, Alicante, Spain

and more 15 locations

Follow-up of NAFLD Patients With MRI-PDFF

Phase 4

Completed

Conditions: NAFLD
Diabetes Type 2

Interventions: Drug: Empagliflozin 25 MG
Drug: Pentoxifylline 400 MG
Other: placebo
Drug: Ursodeoxycholic acid

First Posted Date: 2021-06-02

Last Posted Date: 2022-12-20

Lead Sponsor: Asmaa Abdelfattah Elsayed

Target Recruit Count: 80

Registration Number: NCT04910178

Locations: 🇪🇬
Minya University Hospital, Minya, Egypt

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

Phase 2

Recruiting

Conditions: Hepatitis, Drug-Induced

Interventions: Drug: Mycophenolate Mofetil
Drug: Solu-Medrol
Drug: Ursodeoxycholic acid
Drug: Prednisone tablet

First Posted Date: 2021-03-22

Last Posted Date: 2022-12-14

Lead Sponsor: Inge Marie Svane

Target Recruit Count: 60

Registration Number: NCT04810156

Locations: 🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇩🇰
Odense University Hospital, Odense, Denmark
🇩🇰
Herlev University Hospital, Herlev, Copenhagen, Denmark

and more 2 locations