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Ursodeoxycholic acid
Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and increases bile flow to improve hepatic function and reduce cholestasis.
Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and increases bile flow to improve hepatic function and reduce cholestasis. Used for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Gallstone dissolution.
At a glance
| Generic name | Ursodeoxycholic acid |
|---|---|
| Also known as | UDCAMENT, UDCA, Ursofalk, Ursolit, Ursodiol |
| Sponsor | University of Oxford |
| Drug class | Bile acid |
| Target | Farnesoid X receptor (FXR), TGR5 receptor |
| Modality | Small molecule |
| Therapeutic area | Hepatology/Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Ursodeoxycholic acid (UDCA) is a naturally occurring hydrophilic bile acid that decreases the cholesterol content of bile and promotes its secretion, thereby reducing cholesterol crystallization and gallstone formation. It also has cytoprotective and immunomodulatory properties that reduce hepatocyte injury and inflammation in cholestatic liver diseases. The drug increases the proportion of hydrophilic bile acids in the bile acid pool, improving overall bile composition and hepatic function.
Approved indications
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
- Gallstone dissolution
- Cholestasis of pregnancy
- Cystic fibrosis-associated liver disease
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Pruritus
- 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ursodeoxycholic acid CI brief — competitive landscape report
- Ursodeoxycholic acid updates RSS · CI watch RSS
- University of Oxford portfolio CI