NDAORALTABLET
Approved
Aug 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
FENOGLIDE (fenofibrate) by Salix Pharmaceuticals is α (pparα). First approved in 2007.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FENOGLIDE (fenofibrate) is an oral tablet fibrate approved in 2007 for managing dyslipidemia, particularly elevated triglycerides and abnormal cholesterol profiles. It works by activating PPARα to increase triglyceride clearance, reduce small dense LDL particles, and raise HDL cholesterol. The drug also lowers serum uric acid by increasing urinary excretion.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect cost containment focus and smaller brand team as generic erosion accelerates.
Mechanism of Action
α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity). The resulting fall in triglycerides produces an…
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
563 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
The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
Started Nov 2016
412 enrolled
Type 1 Diabetes MellitusDiabetic RetinopathyDiabetic Nephropathies
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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.