Lipidil, Pravafenix(fenofibrate)
Antara, Cholib, Fenofibrate, Lipofen, Pravafenix, Triglide (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, Triglide (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 |
| TRIGLIDE | Skyepharma | N-021350 RX | 2005-05-07 | 1 products, RLD |
Show 8 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antara | New Drug Application | 2024-08-20 |
| fenofibrate | ANDA | 2024-10-28 |
| fenoglide | New Drug Application | 2021-06-01 |
| lipofen | New Drug Application | 2021-09-21 |
| tricor | New Drug Application | 2024-04-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | HP_0003124 | D006937 | — |
| coronary artery disease | — | D003324 | I25.1 |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
| hyperlipoproteinemias | HP_0010980 | 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
221 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | 6 | 13 | 16 | 11 | 9 | 50 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 1 | 5 | 9 | 10 | 6 | 31 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 1 | 2 | 14 | 8 | 5 | 30 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | 1 | 12 | 8 | 3 | 24 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 6 | 5 | 6 | 18 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 2 | 4 | 4 | 8 | 18 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 3 | 1 | 3 | 8 | 15 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | 1 | 9 | 2 | — | 13 |
| Syndrome | D013577 | — | — | — | 3 | — | 3 | 6 | 12 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 4 | 2 | 4 | 10 |
Show 27 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | — | K74.3 | 2 | 6 | 6 | — | — | 10 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | 2 | 4 | 4 | — | — | 6 |
| Glucose metabolism disorders | D044882 | — | — | — | 1 | 4 | — | — | 4 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | 4 | — | — | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 2 | — | — | 4 |
| Fibrosis | D005355 | — | — | — | 2 | 2 | — | — | 4 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 2 | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | 1 | — | — | 3 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 1 | 2 | — | — | 3 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | — | 1 | 3 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | — | 5 | 19 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 3 | — | — | 3 | 7 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 3 | — | — | 3 | 7 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 3 | — | — | 3 | 6 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 2 | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Weight loss | D015431 | HP_0001824 | — | — | 1 | — | — | 1 | 2 |
| Overweight | D050177 | — | E66.3 | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | 1 | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | 1 | 2 |
Show 18 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | — | 2 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
| Bacterial infections | D001424 | — | A49 | 1 | — | — | — | — | 1 |
| Gram-negative bacterial infections | D016905 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
| Uterine cervical dysplasia | D002578 | EFO_1000910 | N87 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes complications | D048909 | — | — | — | — | — | — | 2 | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 2 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Cytokinesis | D048749 | — | — | — | — | — | — | 1 | 1 |
| Radiodermatitis | D011855 | — | L58 | — | — | — | — | 1 | 1 |
| Endotoxemia | D019446 | — | — | — | — | — | — | 1 | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Lipid metabolism | D050356 | — | — | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
Show 7 more
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
No data
Financial
Revenue by drug
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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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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,405 adverse events reported
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