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Ursodeoxycholic Acid (URSO)
Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and promotes its solubilization, while also exerting cytoprotective and anti-inflammatory effects on hepatocytes and biliary epithelium.
Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and promotes its solubilization, while also exerting cytoprotective and anti-inflammatory effects on hepatocytes and biliary epithelium. Used for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Gallstone dissolution.
At a glance
| Generic name | Ursodeoxycholic Acid (URSO) |
|---|---|
| Also known as | URSO, UDCA |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Drug class | Bile acid |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
URSO decreases cholesterol absorption and secretion into bile, reducing cholestasis and hepatic injury. It also has immunomodulatory properties that may protect against bile acid-induced cellular damage and reduce inflammation in biliary and hepatic tissues. These mechanisms make it useful in cholestatic liver diseases and as a hepatoprotective agent.
Approved indications
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
- Gallstone dissolution
- Cholestasis and liver protection in various hepatic conditions
Common side effects
- Diarrhea
- Abdominal discomfort
- Nausea
- Headache
Key clinical trials
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (PHASE2)
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- The Role of Secondary Bile Acids in Intestinal Inflammation (PHASE2, PHASE3)
- Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine. (PHASE2)
- A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. (PHASE3)
- Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (PHASE3)
- Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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