TheraRadar
Data updated: Jun 28, 2026

FENOFIBRATE (MICRONIZED) (fenofibrate) · CHARTWELL RX

Peroxisome Proliferator-activated Receptor alpha Agonists
Cardiovascular Approved 2002-04-09

Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program...

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
NDA
Small Molecule
17
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Prescription
First Approved
2002-04-09
Routes
ORAL
Dosage Forms
CAPSULE

Companies

CHARTWELL RX PHARMOBEDIENT RHODES PHARMS IMPAX LABS RISING INGENUS PHARMS LLC ALEMBIC Sun Pharma INVAGEN PHARMS Aurobindo Pharma Apotex REYOUNG AJANTA PHARMA LTD TORRENT CHARTWELL GLENMARK PHARMS LTD ANI PHARMS
Active Ingredient: FENOFIBRATE

FENOFIBRATE (MICRONIZED) Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
172 FDA actions from 2002 to 2025
May 2025 SUPPL
Label · Labeling
Jan 2024 ORIGINAL
Update
May 2022 SUPPL
Label · Labeling

What FENOFIBRATE (MICRONIZED) Treats

3 indications

FENOFIBRATE (MICRONIZED) is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

FENOFIBRATE (MICRONIZED) Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LEROCHOL
LIB THERAPEUTICS,
2025 2 indic.
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
Teva
2024 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

48 trials
Trial Sponsor ID Phase Status Title
NCT07572552 36265MD41030/1/26 Ph 2 not yet recruiting Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis
NCT04929379 PERL-FENO STUDY00000156 Ph 2 active not recruiting A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
NCT01320345 FAME 1 EYE FAME0001 ACTRN12611000249954 Ph 3 active not recruiting The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
NCT06174402 KY-20232219-C-1 Ph 2, Ph 3 active not recruiting Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
NCT06755151 KY20232219-C-1-1 Ph 3 recruiting Fenofibrate in Primary Biliary Cholangitis: a Real World Study
NCT07296458 KY-20252505 Ph 3 recruiting FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
NCT04661358 Protocol AF DRCR.net Protocol AF U10EY014231 Ph 3 recruiting Fenofibrate for Prevention of DR Worsening
NCT05514119 FICsDCD results posted 22-007122 Ph 2 terminated A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
NCT06191133 CASE3822 Ph 1 recruiting Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
NCT06155331 Breast cancer and fenofibrate Ph 2 completed Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
NCT06365424 KY20151230-5-1 Ph 2, Ph 3 recruiting Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
NCT05781698 1-2023 Ph 2 completed Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis
NCT06623539 jRCTs031200280 Ph 2 active not recruiting Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease
NCT06451900 prophylactic fenofibrate Ph 4 completed Role of Fenofibrate in Neonatal Jaundice
NCT03615534 results posted 1 Al-KindyCM Ph 4 completed Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
NCT03829514 results posted Pro00079289 Ph 4 completed Fenofibrate in Type 2 Diabetes
NCT03515213 results posted 20163022 Ph 2 completed Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
NCT03510884 results posted EFC14643 2017-001903-60, U1111-1193-0721 Ph 3 completed An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT02823353 KY20151230-4 Ph 3 completed Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT03001817 results posted K-877-301 Ph 3 completed Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
NCT03011450 results posted K-877-303 Ph 3 completed Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
NCT02965911 BJ302-FGRXGB-002 Ph 1, Ph 2 withdrawn Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
NCT03510715 results posted EFC14660 2017-002297-39, U1111-1200-2046 Ph 3 completed An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
NCT02891408 HI results posted GS-US-426-3988 Ph 1 completed Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
NCT01594983 CLCQ908C2201 2012-000872-40 Ph 2 completed A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
NCT01148004 100124 10-CC-0124 Ph 1 completed The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers
NCT02452255 14-0441 NIH RO1GM056687 Ph 2, Ph 3 terminated Fenofibrate and Propranolol in Burn Patients
NCT01574131 11-106 Ph 4 terminated Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients
NCT02984982 ODYSSEY J-IVUS results posted ALIROL08069 U1111-1184-8764 Ph 4 completed Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
NCT02890992 ODYSSEY KIDS results posted DFI14223 2015-003766-85, U1111-1178-4764 Ph 2 completed An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT02455336 results posted B1925-P Ph 2, Ph 3 completed Fenofibrate Treatment in SCI
NCT02262143 ID-ROFE-301 Ph 3 completed Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
NCT02642159 results posted LPS14354 2015-001934-19, U1111-1172-5262 Ph 4 completed Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
NCT01142323 results posted 20100533 Ph 1, Ph 2 terminated Pilot Study of Fenofibrate for PSC
NCT02066207 146DDI13024 Ph 1 completed CKD-337 Drug Interaction Study
NCT01965834 results posted 20110069 Ph 2 terminated Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma
NCT01723735 PKD12910 U1111-1131-3203, 2012-003049-13 Ph 1 completed Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
NCT02886299 CL (746) Ph 4 completed Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis
NCT01426438 results posted ACTG A5293 1U01AI068636 Ph 2 completed Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
NCT01462877 results posted W13-254 Ph 4 completed A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
NCT01666041 GMC-201202 Ph 4 completed Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate
NCT02153879 LOWHDL IISPV-HUSJR-LOWHDL Ph 4 completed Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
NCT00819910 RAFAEL results posted C.2007.122 Ph 4 terminated Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)
NCT01141296 Feno-01 Ph 2 withdrawn Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
NCT01539616 ZYH7.10.001.01 CTRI/2011/11/002147 Ph 2 completed A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
NCT00872599 results posted PPAR Alpha Agonist Grant# DK38226-21 Ph 4 completed The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans
NCT00732485 07-389 SHC 08-GAL-006 Ph 2, Ph 3 withdrawn Mitochondrial Oxidation and Insulin Resistance in Burn Patients Treated With Fenofibrate
NCT01109758 S282.1.002 2007-006147-52 Ph 1 completed Effects of Fenofibrate on Gene Expression in Healthy Volunteers
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FENOFIBRATE (MICRONIZED) FDA Label Details

Indications & Usage

FDA Label (PDF)

Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules are also...

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Data Sources

FDA Approval: ANDA090859 → Label: DailyMed (2021-09-08) → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.