NDAORALCAPSULE
Approved
Dec 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
LIPIDIL (fenofibrate) by AbbVie is acid. First approved in 1993.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIPIDIL (fenofibrate) is an oral fibrate that activates peroxisome proliferator-activated receptor α (PPARα) to reduce triglycerides and improve lipid profiles in patients with dyslipidemia and mixed hyperlipidemia. It works by increasing lipolysis, enhancing lipoprotein lipase activity, and converting small dense LDL particles into larger, more favorable particles that are rapidly cleared from circulation. The drug also modestly raises HDL-cholesterol and reduces serum uric acid levels.
LOE Approaching
As an approaching LOE product with modest competitive pressure (30%), the brand team is likely focused on retention and lifecycle management rather than expansion.
Mechanism of Action
acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate. The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human…
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.