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Ocaliva (OBETICHOLIC ACID)
Ocaliva (generic name: OBETICHOLIC ACID) is a Farnesoid X Receptor Agonist Small molecule drug developed by Intercept Pharms Inc. It is currently FDA-approved (first approved 2016) for Primary cholangitis.
Ocaliva, also known as obeticholic acid, is a small molecule used to treat certain conditions, including Primary Biliary Cirrhosis, as per a Phase 3 clinical trial. It is administered as an intervention to patients with these conditions.
At a glance
| Generic name | OBETICHOLIC ACID |
|---|---|
| Sponsor | Intercept Pharms Inc |
| Drug class | Farnesoid X Receptor Agonist |
| Target | Bile acid receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2016 |
Approved indications
- Primary cholangitis
Common side effects
Key clinical trials
- Testing Obeticholic Acid for Familial Adenomatous Polyposis (PHASE2)
- Obeticholic Acid for Prevention in Barrett's Esophagus (PHASE2)
- 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 to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy (PHASE2,PHASE3)
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (PHASE2)
- Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment. (PHASE2)
- Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ocaliva CI brief — competitive landscape report
- Ocaliva updates RSS · CI watch RSS
- Intercept Pharms Inc portfolio CI
Frequently asked questions about Ocaliva
What is Ocaliva?
What is Ocaliva used for?
Who makes Ocaliva?
What is the generic name of Ocaliva?
What drug class is Ocaliva in?
When was Ocaliva approved?
What development phase is Ocaliva in?
What does Ocaliva target?
Related
- Drug class: All Farnesoid X Receptor Agonist drugs
- Target: All drugs targeting Bile acid receptor
- Manufacturer: Intercept Pharms Inc — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Primary cholangitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing