NDAORALCAPSULE
Approved
Nov 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
LOVAZA (omega-3-acid ethyl esters) by Viatris (2) is understood. First approved in 2004.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOVAZA is an oral capsule formulation of omega-3-acid ethyl esters approved in 2004 to treat hypertriglyceridemia. It reduces triglyceride synthesis in the liver through multiple mechanisms including inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase and increased fatty acid oxidation. The drug works by providing EPA and DHA as poor substrates for triglyceride synthesis while enhancing plasma lipoprotein lipase activity.
$7MPart D
LOE ApproachingDeclining
Mature product in LOE phase with modest spending ($7M) and declining Part D claims indicates contracting team and reduced commercial investment opportunity.
Mechanism of Action
understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. LOVAZA may reduce the synthesis of TG…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Started Dec 2016
53 enrolled
Hyperlipidemia
Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
Started Aug 2016
37 enrolled
Hyperlipidemia
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
Started Oct 2014
30 enrolled
Severe Hypertriglyceridemia
Lovaza Mechanisms of Action
Started Aug 2012
40 enrolled
Moderate Hypertriglyceridemia.
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
Started Jun 2012
58 enrolled
Non Familial Chylocmicronemia Syndrome (Non-FCS)
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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.