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Drug ReportsFenofibrate
Lipidil, Pravafenix(fenofibrate)
Antara, Cholib, Fenofibrate, Lipofen, Pravafenix (fenofibrate) is a small molecule pharmaceutical. Fenofibrate was first approved as Lipidil on 1993-12-31. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It has been approved in Europe to treat dyslipidemias. The pharmaceutical is active against peroxisome proliferator-activated receptor alpha. In addition, it is known to target chloride channel protein 1 and fatty acid-binding protein, liver.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Antara, Fenofibrate, Lipofen, Zuragard (discontinued: Antara, Fenofibrate, Fenoglide, Lipofen, Tricor, Triglide)
Combinations
Chloraprep one-step, Chloraprep triple swabstick, Duraprep, Prevantics maxi swabstick, Soluprep
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fenofibrate
Tradename
Company
Number
Date
Products
LIPOFENCipher PharmaceuticalsN-021612 RX2006-01-11
2 products, RLD, RS
ANTARA (MICRONIZED)Lupin ResearchN-021695 RX2004-11-30
2 products, RLD, RS
Show 8 discontinued
Chlorhexidine gluconate
+
Isopropyl alcohol
Tradename
Company
Number
Date
Products
SOLUPREP S3MN-208288 OTC2018-08-08
1 products, RLD, RS
CHLORAPREP ONE-STEPBDN-020832 OTC2000-07-14
1 products, RLD, RS
CHLORAPREP WITH TINTBDN-020832 OTC2005-05-03
1 products, RLD, RS
CHLORAPREP ONE-STEP FREPPBDN-020832 OTC2002-04-26
1 products, RLD, RS
CHLORAPREP ONE-STEPBDN-020832 OTC2003-08-20
1 products, RLD, RS
CHLORAPREP WITH TINTBDN-020832 OTC2006-04-03
1 products, RLD, RS
CHLORAPREP ONE-STEPBDN-020832 OTC2006-11-21
1 products, RLD, RS
CHLORAPREP WITH TINTBDN-020832 OTC2006-10-10
1 products, RLD, RS
CHLORAPREP ONE-STEPBDN-020832 OTC2008-10-23
1 products, RLD, RS
CHLORAPREP ONE-STEP SEPPBDN-021555 OTC2002-10-07
1 products, RLD, RS
Show 5 marketed
Isopropyl alcohol
Tradename
Company
Number
Date
Products
ZURAGARDZurex PharmaN-210872 OTC2019-04-26
1 products, RLD, RS
Iodine povacrylex
+
Isopropyl alcohol
Tradename
Company
Number
Date
Products
DURAPREP3MN-021586 OTC2006-09-29
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
antaraNew Drug Application2024-08-20
fenofibrateANDA2025-02-20
fenoglideNew Drug Application2011-05-13
lipofenNew Drug Application2021-09-21
tricorNew Drug Application2024-11-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
coronary artery disease—D003324I25.1
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
periodontal diseases—D010510K05.6
infectious skin diseases—D012874—
gram-negative bacterial infections—D016905—
oral candidiasisEFO_0007406D002180B37.0
gram-positive bacterial infections—D016908—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Fenofibrate, Antara (Micronized), Lupin
93144472033-05-31DPU-1447, U-1448
80262812025-04-22U-1447, U-1448
Fenofibrate, Fenoglide, Salix
76589442024-12-09DP
81241252024-10-01DPU-1234
84810782024-10-01DPU-1416
91738472024-10-01DP
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AB: Fibrates, lipid modifying drugs, plain
— C10AB05: Fenofibrate
— C10AB11: Choline fenofibrate
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA03: Pravastatin and fenofibrate
— C10BA04: Simvastatin and fenofibrate
— C10BA09: Rosuvastatin and fenofibrate
— C10BA12: Pravastatin, ezetimibe and fenofibrate
HCPCS
No data
Clinical
Clinical Trials
336 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyslipidemiasD050171——6131611748
HypertriglyceridemiaD015228EFO_0004211—15910631
HyperlipidemiasD006949EFO_0003774E78.512148530
HyperlipoproteinemiasD006951———1127323
InfectionsD007239EFO_0000544—2—47821
Type 2 diabetes mellitusD003924EFO_0001360E11—265618
Diabetes mellitusD003920EFO_0000400E08-E13—244818
Surgical wound infectionD013530——1245416
Metabolic syndromeD024821EFO_0000195E88.810—313815
Communicable diseasesD003141——1—45515
Show 57 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biliary liver cirrhosisD008105—K74.3268——12
CholangitisD002761HP_0030151K83.0246——8
VomitingD014839—R11.1111—35
Glucose metabolism disordersD044882———14——4
Metabolic diseasesD008659EFO_0000589E88.9—14——4
Liver cirrhosisD008103EFO_0001422K74.0—22——4
FibrosisD005355———22——4
Diabetic nephropathiesD003928EFO_0000401——12——3
Kidney diseasesD007674EFO_0003086N081—2——3
Type 1 diabetes mellitusD003922EFO_0001359E10—21——3
Show 22 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———141——621
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8113——37
Fatty liverD005234EFO_0003934—13——37
Liver diseasesD008107EFO_0001421K70-K77—3——36
InflammationD007249MP_0001845——1——23
NeoplasmsD009369—C8011——13
Weight lossD015431———1——12
OverweightD050177—E66.3—2———2
Multiple myelomaD009101—C90.0—1——12
Plasma cell neoplasmsD054219———1——12
Show 27 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424—A491————1
Gram-negative bacterial infectionsD016905——1————1
InfertilityD007246EFO_0000545—1————1
Rotavirus infectionsD012400——1————1
Depressive disorderD003866EFO_1002014F32.A1————1
Carcinoma in situD002278—D09.91————1
Uterine cervical dysplasiaD002578EFO_1000910N871————1
Chronic renal insufficiencyD051436—N181————1
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes complicationsD048909——————22
Vascular diseasesD014652EFO_0004264I77————22
RadiodermatitisD011855—L58————22
MalnutritionD044342EFO_0008572E40-E46————22
ThrombosisD013927——————22
Myofascial pain syndromesD009209EFO_1001054—————22
Bites and stingsD001733——————22
SchizophreniaD012559EFO_0000692F20————11
CytokinesisD048749——————11
Vitamin d deficiencyD014808EFO_0003762E55————11
Show 41 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFenofibrate
INNfenofibrate
Description
Fenofibrate is a chlorobenzophenone that is (4-chlorophenyl)(phenyl)methanone substituted by a [2-methyl-1-oxo-1-(propan-2-yloxy)propan-2-yl]oxy group at position 1 on the phenyl ring. It has a role as an antilipemic drug, an environmental contaminant, a xenobiotic and a geroprotector. It is a chlorobenzophenone, a member of monochlorobenzenes, an aromatic ether and an isopropyl ester. It is functionally related to a benzophenone.
Classification
Small molecule
Drug classantihyperlipidemics (clofibrate type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Identifiers
PDB—
CAS-ID49562-28-9
RxCUI—
ChEMBL IDCHEMBL672
ChEBI ID5001
PubChem CID3339
DrugBankDB01039
UNII IDU202363UOS (ChemIDplus, GSRS)
Target
Agency Approved
PPARA
PPARA
Organism
Homo sapiens
Gene name
PPARA
Gene synonyms
NR1C1, PPAR
NCBI Gene ID
5465
Protein name
peroxisome proliferator-activated receptor alpha
Protein synonyms
Nuclear receptor subfamily 1 group C member 1, peroxisome proliferative activated receptor, alpha
Uniprot ID
Q9Y3N1
Mouse ortholog
Ppara (19013)
peroxisome proliferator-activated receptor alpha (P23204)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Tricor – Elan Corporation
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Tricor – AbbVie
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Tabular view
Estimated US medical usage
Fenofibrate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 63,259 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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26,509 adverse events reported
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