NDAORALCAPSULE
Approved
May 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
3/8 — Basic
Drug data last refreshed 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPANOVA is an oral capsule formulation of omega-3-carboxylic acids approved by the FDA in May 2014 for the treatment of hypertriglyceridemia. It is a prescription-strength omega-3 derivative designed to reduce triglyceride levels in patients with elevated baseline triglycerides.
Peak6.5 years to LOE
Product is in peak lifecycle phase with stable market presence; brand team likely focused on market maintenance and managed care penetration rather than growth initiatives.
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 (15)
A Ph 1 Study of Epanova® in Healthy Chineses
Started Jun 2018
14 enrolled
Healthy Subjects
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Started Sep 2015
78 enrolled
Non-alcoholic Fatty Liver Disease (NAFLDHypertriglyceridemia
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
Started Mar 2015
490 enrolled
Diabetes Mellitus, Type 2Exocrine Pancreatic Insufficiency
Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions
Started Feb 2015
137 enrolled
Relative BioavailabilityAUCCmax+1 more
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Started Oct 2014
13,078 enrolled
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
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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.