OCALIVA
Peakobeticholic acid
NDAORALTABLETPriority Review
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OCALIVA (obeticholic acid) is an oral small-molecule bile acid receptor agonist approved for primary biliary cholangitis (PBC), a rare autoimmune liver disease. It works by activating the farnesoid X receptor (FXR) and G-protein coupled bile acid receptor 1 (TGR5) to reduce cholestasis and inflammation. The drug is indicated as a monotherapy or adjunct to ursodeoxycholic acid (UDCA) in patients with PBC.
$164MPart D
Peak9.8 years to LOEProduct is in peak commercial phase with $164M annual Part D spending, indicating established market penetration and stable but mature revenue trajectory requiring focus on retention and indication expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
Started Nov 2021
52 enrolled
Pruritus
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis
Started Oct 2021
100 enrolled
PBC
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Started Jul 2021
120 enrolled
Primary Biliary Cirrhosis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
Started Aug 2019
19 enrolled
Cholestasis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.