Fenofibric acid
Fenofibric Acid, Fibricor (fenofibric acid) is a small molecule pharmaceutical. Fenofibric acid was first approved as Fibricor on 2009-08-14. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It is known to target peroxisome proliferator-activated receptor alpha, chloride channel protein 1, and fatty acid-binding protein, liver.
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fenofibric acid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FIBRICOR | Athena Neurosciences | N-022418 DISCN | 2009-08-14 | 2 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fenofibrate | ANDA | 2023-05-26 |
| fenofibric acid | ANDA | 2023-05-18 |
| fibricor | New Drug Application | 2020-12-29 |
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
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
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | 1 | 6 | 3 | 11 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | 2 | 5 | ||
| Food-drug interactions | D018565 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Microcirculation | D008833 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FENOFIBRIC ACID |
| 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)(Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1)C(=O)O |
Target
Agency Approved
No data
Alternate
PPARA
PPARA
CLCN1
CLCN1
FABP1
FABP1
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)
Variants
Clinical Variant
No data
Financial
No data
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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1,867 adverse events reported
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