ANTARA (MICRONIZED)
Peakfenofibrate
NDAORALCAPSULE
Approved
Nov 2004
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Peroxisome Proliferator-activated Receptor alpha Agonists
Pharmacologic Class:
Peroxisome Proliferator Receptor alpha Agonist
Indications (7)
severe hypertriglyceridemia (TG greater thanequal to 500 mg/dL) ()type 2 diabetes mellituscoronary heart disease morbiditymortality in two largerandomized controlled trials of patients with type 2 diabetes mellitus [ see Warningsrandomized controlled trials of patients with type 2 diabetes mellitus ()
Clinical Trials (5)
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
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)
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
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Started Nov 2012
79 enrolled
Hypercholesterolemia
Loss of Exclusivity
LOE Date
May 31, 2033
88 months away
Patent Expiry
May 31, 2033
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9314447 | May 31, 2033 | Product | U-1448 |