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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Antara, Fenofibrate, Lipofen (discontinued: Antara, Fenofibrate, Fenoglide, Lipofen, Tricor, Triglide)
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 |
|---|---|---|---|---|
| LIPOFEN | Cipher Pharmaceuticals | N-021612 RX | 2006-01-11 | 2 products, RLD, RS |
| ANTARA (MICRONIZED) | Lupin Research | N-021695 RX | 2004-11-30 | 2 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antara | New Drug Application | 2024-08-20 |
| fenofibrate | ANDA | 2025-02-12 |
| fenoglide | New Drug Application | 2011-05-13 |
| lipofen | New Drug Application | 2021-09-21 |
| tricor | New Drug Application | 2024-11-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | — | D006937 | — |
| coronary artery disease | — | D003324 | I25.1 |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
| hyperlipoproteinemias | — | D006951 | — |
Agency Specific
FDA
EMA
No data
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
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Clinical
Clinical Trials
224 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | 1 | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fenofibrate |
| INN | fenofibrate |
| 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 class | antihyperlipidemics (clofibrate type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 49562-28-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL672 |
| ChEBI ID | 5001 |
| PubChem CID | 3339 |
| DrugBank | DB01039 |
| UNII ID | U202363UOS (ChemIDplus, GSRS) |
Target
Agency Approved
PPARA
PPARA
Organism
Homo sapiens
Gene name
PPARA
Gene synonyms
NR1C1, PPAR
NCBI Gene ID
Protein name
peroxisome proliferator-activated receptor alpha
Protein synonyms
Nuclear receptor subfamily 1 group C member 1, peroxisome proliferative activated receptor, alpha
Uniprot ID
Mouse ortholog
Ppara (19013)
peroxisome proliferator-activated receptor alpha (P23204)
Alternate
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Variants
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Financial
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Tricor – Elan Corporation
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Tricor – AbbVie
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Estimated US medical usage
Fenofibrate
Total medical expenditures per year (USD, in millions)
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PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,813 adverse events reported
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