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Drug

Fenofibrate

Established medicine
ClassPeroxisome proliferator-activated receptor alpha agonistResearchActive indication expansion
Also known as 2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester, Antara, FNF, Fenofibrate Micronized+15 more

2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester, Antara, FNF, Fenofibrate Micronized, Fenofibric Acid, Fenoglide, Fibricor, Finofibrate, Isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate, Isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate, Lipidil Supra, Lipofen, Lofibra, Procetofen, TriCor, Triglide, Trilipix, Fenofibrato, Fenofibratum.

RxNorm8703ChEMBLCHEMBL672ATCC10AB05UNIIU202363UOS
2
Research papers
15
Active clinical trials
PPARA
Primary target
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomised Trial to Evaluate the Efficacy on Retinopathy and Safety of Fenofibrate in Adults With Type 1 Diabetes. A Multicentre Double-blind Placebo-controlled Study in Australia and Internationally.

Clinical trial2026-08-28Primary completion · ClinicalTrials.gov

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Clinical trial2026-08-20Results expected Q3 2026 · ClinicalTrials.gov

Label change: FENOFIBRATE (ANDA211122)

Regulatory2026-08-17FDA

Label change: FENOFIBRATE (ANDA204475)

Regulatory2026-08-05FDA

Supplemental approval: FENOFIBRATE (ANDA208476)

Regulatory2026-08-04FDA

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

Clinical trial2026-07-29Status changed to Active, not recruiting · ClinicalTrials.gov

Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Clinical trial2026-07-17Results expected Q1 2028 · ClinicalTrials.gov

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

Clinical trial2026-06-29Results expected Q4 2029 · ClinicalTrials.gov

Recall (Class II): FENOFIBRATE

Regulatory2026-05-28FDA

The Novel Role of PPAR Alpha in the Brain: Promising Target in Therapy of Alzheimer's Disease and Other Neurodegenerative Disorders.

Research2020-03-13Neurochemical research

Fenofibrate lowers blood pressure in salt-sensitive but not salt-resistant hypertension.

Research2013-04-01Journal of hypertension

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers LDL cholesterol in hyperlipidaemia
30%Very low confidence
Uncertainty ±35%Evidence coverage: PartialUpdated 17 August 2026

High point estimate, but substantial uncertainty remains.

Evidence is mixed — 2 supporting evidence families · contradictory evidence

Confidence is moderated by material contradictory evidence and limited publication incorporation, despite broad trial support.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fenofibrate
Aliases & brands
2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl esterAntaraFNFFenofibrate MicronizedFenofibric AcidFenoglideFibricorFinofibrateIsopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionateIsopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionateLipidil SupraLipofenLofibraProcetofenTriCorTriglideTrilipixFenofibratoFenofibratum
RxNorm CUI
8703
ChEMBL ID
CHEMBL672
ATC codes
C10AB05
UNII
U202363UOS
Primary mechanism
Peroxisome proliferator-activated receptor alpha agonist
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Peroxisome proliferator-activated receptor alpha
PPARA · Q07869
AGONISTPeroxisome proliferator-activated receptor alpha agonist

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-06-23
Latest approval
2026-08-04
Authorities
FDA
Total events
12
fdaU.S. Food and Drug Administration· 12 events
2026-08-17Label change
Label change: FENOFIBRATE (ANDA211122)
Evidence ↗
2026-08-05Label change
Label change: FENOFIBRATE (ANDA204475)
Evidence ↗
2026-08-04Supplemental approval
Supplemental approval: FENOFIBRATE (ANDA208476)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

129 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
129
registered trials across all phases
LATEST COMPLETION 2025
15
Active studies
8
Recruiting
82
Late-stage (III+)
78
Completed
36
Discontinued
PHASE DISTRIBUTIONn = 129
Early Phase 12Phase 117Phase 1 / 22Phase 226Phase 2 / 39Phase 324Phase 424Phase N / A25

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome

Unknown statusPH IVUniversity of Colorado, Denvern=442025

A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes

CompletedPH IVKey trialUniversity of Oxfordn=1,1512024

Prophylactic Role of Fenofibrate in Neonatal Jaundice

CompletedPH IVAin Shams Universityn=752023

Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Unknown statusPH IVAlaa Hassan ElBazn=802020

A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

Unknown statusPH IVDaewon Pharmaceutical Co., Ltd.n=1802020

Recent completions

Trials that read out recently, adding to the completed evidence base.

Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis

CompletedPH II/IIITanta Universityn=602025

A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

CompletedPH IHan Yingn=302025

Clinical Study to Evaluate the Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

CompletedPH IITanta Universityn=442025

Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

CompletedPH IITanta Universityn=602024

Physiopathological Study of Genetic Modulation of Cardiovascular Effect of PPAR-Alpha Activation (MAGNETIC-PPARA)

CompletedN/AMario Luca Morierin=2002024

Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients

CompletedN/ADamanhour Universityn=502024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132020
Journals, researchers & institutions
Top journals
  • Journal of hypertension1
  • Neurochemical research1
Leading researchers
  • Brown NJ1
  • Gilbert K1
  • Jeżyna M1
  • Luther JM1
  • Nian H1
  • Strosznajder AK1
  • Strosznajder JB1
  • Wójtowicz S1
Leading institutions
free-text, unnormalised
  • Medical University of Bialystok1
  • Mossakowski Medical Research Centre Polish Academy of Sciences1
  • Vanderbilt School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.