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, Zuragard (discontinued: Antara, Fenofibrate, Fenoglide, Lipofen, Tricor, Triglide)
CombinationsChloraprep 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 |
|---|---|---|---|---|
| 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 |
Show 8 discontinued
Chlorhexidine gluconate
+
Isopropyl alcohol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SOLUPREP S | 3M | N-208288 OTC | 2018-08-08 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP | BD | N-020832 OTC | 2000-07-14 | 1 products, RLD, RS |
| CHLORAPREP WITH TINT | BD | N-020832 OTC | 2005-05-03 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP FREPP | BD | N-020832 OTC | 2002-04-26 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP | BD | N-020832 OTC | 2003-08-20 | 1 products, RLD, RS |
| CHLORAPREP WITH TINT | BD | N-020832 OTC | 2006-04-03 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP | BD | N-020832 OTC | 2006-11-21 | 1 products, RLD, RS |
| CHLORAPREP WITH TINT | BD | N-020832 OTC | 2006-10-10 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP | BD | N-020832 OTC | 2008-10-23 | 1 products, RLD, RS |
| CHLORAPREP ONE-STEP SEPP | BD | N-021555 OTC | 2002-10-07 | 1 products, RLD, RS |
Show 5 marketed
Isopropyl alcohol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZURAGARD | Zurex Pharma | N-210872 OTC | 2019-04-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antara | New Drug Application | 2024-08-20 |
| fenofibrate | ANDA | 2025-04-19 |
| fenoglide | New Drug Application | 2011-05-13 |
| lipofen | New Drug Application | 2021-09-21 |
| tricor | New Drug Application | 2024-11-14 |
Indications
FDA
EMA
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
No data
Clinical
Clinical Trials
339 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 | — | — | 6 | 13 | 16 | 11 | 7 | 48 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 1 | 5 | 9 | 10 | 6 | 31 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | 2 | 14 | 8 | 5 | 30 |
| Hyperlipoproteinemias | D006951 | — | — | — | 1 | 12 | 7 | 3 | 23 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 4 | 7 | 8 | 21 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 6 | 5 | 6 | 18 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | 4 | 4 | 8 | 18 |
| Surgical wound infection | D013530 | — | — | 1 | 2 | 4 | 5 | 4 | 16 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 3 | 1 | 3 | 8 | 15 |
| Communicable diseases | D003141 | — | — | 1 | — | 4 | 5 | 5 | 15 |
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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 | 8 | — | — | 12 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | 2 | 5 | 6 | — | — | 9 |
| Vomiting | D014839 | — | R11.1 | 1 | 1 | 1 | — | 3 | 5 |
| 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 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | 2 | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | 1 | — | — | 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 | — | — | — | 14 | 1 | — | — | 6 | 21 |
| 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 | EFO_0001421 | K70-K77 | — | 3 | — | — | 3 | 6 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 2 | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 3 |
| Weight loss | D015431 | — | — | — | 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 29 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 1 | — | — | — | — | 1 |
| Gram-negative bacterial infections | D016905 | — | — | 1 | — | — | — | — | 1 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | — | 1 |
| Rotavirus infections | D012400 | — | — | 1 | — | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
| Uterine cervical dysplasia | D002578 | EFO_1000910 | N87 | 1 | — | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 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 |
| Radiodermatitis | D011855 | — | L58 | — | — | — | — | 2 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Thrombosis | D013927 | — | — | — | — | — | — | 2 | 2 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | — | 2 | 2 |
| Bites and stings | D001733 | — | — | — | — | — | — | 2 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Cytokinesis | D048749 | — | — | — | — | — | — | 1 | 1 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
Show 45 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
No data
Variants
No data
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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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Price per prescription (USD)
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Trends
PubMed Central
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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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