NDAORALCAPSULE
Approved
Jan 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
LIPOFEN (fenofibrate) by Cipher Pharmaceuticals is peroxisome proliferator-activated receptor alpha agonists [moa]. First approved in 2006.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIPOFEN (fenofibrate) is an oral fibrate capsule approved in 2006 that activates peroxisome proliferator-activated receptor alpha to lower triglycerides and improve lipid profiles. It is used to treat dyslipidemia and hypertriglyceridemia in patients at risk for cardiovascular disease. The drug works by increasing lipolysis and reducing VLDL production in the liver.
$0.205MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D engagement (363 claims, $205K spend) suggests a mature, commoditized asset with limited commercial growth opportunities.
Mechanism of Action
Peroxisome Proliferator-activated Receptor alpha Agonists
Pharmacologic Class:
Peroxisome Proliferator Receptor alpha Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Started Jun 2023
56 enrolled
DyslipidemiaAtherosclerosisDiabetes Mellitus, Type 2
Fenofibrate for Prevention of DR Worsening
Started Mar 2021
560 enrolled
Diabetic Retinopathy
Fenofibrate for Patients With COVID-19 Requiring Hospitalization
Started Jan 2021
55 enrolled
Corona Virus Disease (COVID-19)Respiratory Distress SyndromeSARS-CoV-2 Infection
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
Started Jul 2018
180 enrolled
Dyslipidemias
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
Started Sep 2016
74 enrolled
Nonalcoholic Steatohepatitis (NASH)
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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.