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Placebo Combined With Ursodeoxycholic Acid
Ursodeoxycholic acid increases bile flow and reduces cholesterol saturation in bile to prevent gallstone formation and improve biliary function.
Ursodeoxycholic acid increases bile flow and reduces cholesterol saturation in bile to prevent gallstone formation and improve biliary function. Used for Gallstone prevention or dissolution (Phase 3 indication, specific condition not fully specified).
At a glance
| Generic name | Placebo Combined With Ursodeoxycholic Acid |
|---|---|
| Also known as | UDCA 13-15mg/kg/d |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Drug class | Bile acid |
| Target | Farnesoid X receptor (FXR), TGR5 |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid that works by decreasing cholesterol secretion into bile and increasing the solubility of cholesterol, thereby reducing the lithogenicity of bile. It also has cytoprotective and anti-inflammatory properties that may benefit hepatic and biliary tissues. The placebo control in this combination is used to assess the true efficacy of UDCA in the trial design.
Approved indications
- Gallstone prevention or dissolution (Phase 3 indication, specific condition not fully specified)
Common side effects
- Diarrhea
- Abdominal discomfort
- Nausea
Key clinical trials
- Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PHASE3)
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis (PHASE2, PHASE3)
- Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis (PHASE2, PHASE3)
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC (PHASE2)
- Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis (PHASE3)
- Combination Antiretroviral Therapy (cART) for PBC (PHASE2)
- Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) (PHASE2)
- Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (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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