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

Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis

Phase 3

Completed

Conditions: PBC

Interventions: Drug: UDCA
Drug: OCA
Drug: Placebo

First Posted Date: 2024-12-04

Last Posted Date: 2024-12-04

Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

Phase 4

Not yet recruiting

Conditions: Gastric Intestinal Metaplasia

Interventions: Drug: Placebo
Drug: Ursodeoxycholic Acid

First Posted Date: 2024-09-24

Last Posted Date: 2024-09-24

Lead Sponsor: Yongquan Shi

Target Recruit Count: 196

Registration Number: NCT06610760

Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Phase 4

Not yet recruiting

Conditions: Neonatal Hyperbilirubinemia

Interventions: Drug: Zinc sulfate
Drug: Ursodeoxycholic acid

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)

Phase 2

Recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Fenofibrate
Drug: UDCA

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

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Phase 2

Recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Fenofibrate
Drug: Placebo
Drug: UDCA

First Posted Date: 2023-12-18

Last Posted Date: 2024-01-02

Lead Sponsor: Han Ying

Target Recruit Count: 184

Registration Number: NCT06174402

Locations: 🇨🇳
Xijing Hospital, Xi'an, Shaanxi, China

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

Not Applicable

Not yet recruiting

Conditions: Partial Liver Resection
Liver Regeneration
Ursodeoxycholic Acid

Interventions: Other: Standard Medical Treatment
Drug: Ursodeoxycholic acid

First Posted Date: 2023-10-19

Last Posted Date: 2023-10-19

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 80

Registration Number: NCT06091787

Locations: 🇮🇳
Institute of Liver and Biliary Sciences, New Delhi, India

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

Phase 2

Recruiting

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Ursodeoxycholic acid

First Posted Date: 2023-06-15

Last Posted Date: 2023-06-15

Lead Sponsor: Tanta University

Target Recruit Count: 88

Registration Number: NCT05902468

Locations: 🇪🇬
Faculty of medicine, Tanta University, Tanta, El-Gharbia, Egypt
🇪🇬
Faculty of Medicine, Menoufia University, Shibīn Al Kawm, Menoufia, Egypt

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

Recruiting

Conditions: COVID-19 Infection

Interventions: Drug: ursodeoxycholic acid

First Posted Date: 2023-04-13

Last Posted Date: 2023-04-13

Lead Sponsor: Beijing Ditan Hospital

Target Recruit Count: 2000

Registration Number: NCT05812612

Locations: 🇨🇳
Department of Hepatology Division 2, Beijing Ditan Hospital, Beijing, Beijing, China

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Phase 2

Recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Placebo
Drug: Fenofibrate 200mg
Drug: UDCA

First Posted Date: 2023-03-01

Last Posted Date: 2024-04-10

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 104

Registration Number: NCT05749822

Locations: 🇨🇳
Xijing Hospital, Xi'an, Shaanxi, China

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery

Phase 4

Active, not recruiting

Conditions: Cardiac Surgery

Interventions: Drug: Nirmatrelvir/ritonavir
Drug: Ursodeoxycholic acid

First Posted Date: 2023-01-19

Last Posted Date: 2023-04-10

Lead Sponsor: China National Center for Cardiovascular Diseases

Target Recruit Count: 491

Registration Number: NCT05690646

Locations: 🇨🇳
Fuwai Hospital, Beijing, Beijing, China

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