Last reviewed · How we verify
Obeticholic Acid Tablets（OCA）
Obeticholic acid is a farnesoid X receptor (FXR) agonist that reduces bile acid synthesis and improves liver function by modulating nuclear receptor signaling.
Obeticholic acid is a farnesoid X receptor (FXR) agonist that reduces bile acid synthesis and improves liver function by modulating nuclear receptor signaling. Used for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH).
At a glance
| Generic name | Obeticholic Acid Tablets（OCA） |
|---|---|
| Sponsor | Nanjing Chia-tai Tianqing Pharmaceutical |
| Drug class | Farnesoid X receptor (FXR) agonist |
| Target | FXR (Farnesoid X Receptor) |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
OCA activates the farnesoid X receptor, a nuclear receptor that regulates bile acid homeostasis and metabolic pathways. By activating FXR, the drug reduces hepatic bile acid synthesis, decreases liver inflammation, and improves markers of cholestasis and fibrosis. This mechanism makes it particularly useful in cholestatic liver diseases where bile acid accumulation drives hepatocellular injury.
Approved indications
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
- Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
Common side effects
- Pruritus (itching)
- Fatigue
- Abdominal pain
- Diarrhea
- Nausea
Key clinical trials
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC (PHASE2)
- To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate (PHASE3)
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (PHASE2)
- Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis (PHASE3)
- Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (PHASE3)
- Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (NA)
- Obeticholic Acid in Pediatric Subjects With Biliary Atresia (PHASE2)
- Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis (PHASE4)
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:
- Obeticholic Acid Tablets（OCA） CI brief — competitive landscape report
- Obeticholic Acid Tablets（OCA） updates RSS · CI watch RSS
- Nanjing Chia-tai Tianqing Pharmaceutical portfolio CI