Lipidil, Pravafenix(fenofibrate)
Antara, Cholib, Fenoglide, Lipofen, Pravafenix, Tricor, 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
Trade Name
FDA
EMA
Antara, Fenoglide, Lipofen, Tricor, Triglide (generic drugs available since 2002-04-09, discontinued: Lipidil)
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 |
|---|---|---|---|---|
| TRICOR | AbbVie | N-021656 RX | 2004-11-05 | 2 products, RLD, RS |
| LIPOFEN | Cipher Pharmaceuticals | N-021612 RX | 2006-01-11 | 2 products, RLD, RS |
| ANTARA (MICRONIZED) | Lupin Research | N-021695 RX | 2004-11-30 | 3 products, RLD, RS |
| FENOGLIDE | Salix Pharmaceuticals | N-022118 RX | 2007-08-10 | 2 products, RLD, RS |
| TRIGLIDE | Skyepharma | N-021350 RX | 2005-05-07 | 1 products, RLD |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antara | New Drug Application | 2023-01-01 |
| fenofibrate | ANDA | 2023-05-26 |
| fenoglide | New Drug Application | 2019-05-22 |
| lipofen | New Drug Application | 2021-09-21 |
| tricor | New Drug Application | 2023-02-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| coronary artery disease | — | D003324 | I25.1 |
| hypercholesterolemia | HP_0003124 | D006937 | — |
| hyperlipoproteinemias | — | D006951 | — |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fenofibrate, Antara (Micronized), Lupin | |||
| 9314447 | 2033-05-31 | DP | U-1447, U-1448 |
| 8026281 | 2025-04-22 | U-1447, U-1448 | |
| Fenofibrate, Fenoglide, Salix | |||
| 7658944 | 2024-12-09 | DP | |
| 8124125 | 2024-10-01 | DP | U-1234 |
| 8481078 | 2024-10-01 | DP | U-1416 |
| 9173847 | 2024-10-01 | DP | |
| Fenofibrate, Tricor, Abbvie | |||
| 7276249 | 2023-02-21 | DP | |
| 7320802 | 2023-02-21 | U-847 | |
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
169 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 | 5 | 8 | 6 | 8 | 5 | 29 | |
| Hypertriglyceridemia | D015228 | EFO_0004211 | 1 | 3 | 4 | 9 | 5 | 22 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | 2 | 8 | 3 | 3 | 16 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 5 | 5 | 3 | 14 |
| Hypercholesterolemia | D006937 | HP_0003124 | 1 | 1 | 5 | 2 | — | 9 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 2 | 4 | 8 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 2 | — | 1 | 4 | 7 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | 3 | 3 | 1 | 7 | |
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | 1 | 4 | 6 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 1 | 1 | 1 | 5 |
Show 10 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 | 1 | 3 | 2 | — | — | 5 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 2 | — | 2 | 4 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 2 | — | — | 3 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | 1 | 3 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | 1 | — | — | 1 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | 1 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | — | — | 1 | |
| Hyperlipoproteinemia type v | D006954 | Orphanet_70470 | E78.3 | — | — | 1 | — | — | 1 |
| Hyperlipoproteinemias | D006951 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | 1 | — | — | 5 | 11 | ||
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | — | — | 1 | 3 |
| Leukemia | D007938 | C95 | — | 1 | — | — | — | 1 | |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Sarcoma | D012509 | — | 1 | — | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | 1 | |
| Huntington disease | D006816 | G10 | — | 1 | — | — | — | 1 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | C90.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | — | — | — | — | 2 | 2 | ||
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Cytokinesis | D048749 | — | — | — | — | 1 | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Neonatal jaundice | D007567 | P59.9 | — | — | — | — | 1 | 1 | |
| Radiodermatitis | D011855 | L58 | — | — | — | — | 1 | 1 | |
| Diabetes complications | D048909 | — | — | — | — | 1 | 1 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | 1 | 1 |
Show 4 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 | 221100 |
| 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
CLCN1
CLCN1
FABP1
FABP1
Organism
Homo sapiens
Gene name
CLCN1
Gene synonyms
CLC1
NCBI Gene ID
Protein name
chloride channel protein 1
Protein synonyms
chloride channel 1, skeletal muscle, Chloride channel protein, skeletal muscle, chloride channel, voltage-sensitive 1, clC-1
Uniprot ID
Mouse ortholog
Clcn1 (12723)
chloride channel protein 1 (Q9QVY5)
Variants
Clinical Variant
No data
Financial
Tricor - Elan Corporation
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Tricor - AbbVie
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,314 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,825 adverse events reported
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