choline fenofibrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| clofibrate derivatives, peroxisome proliferator activated receptor-alpha(PPAR-alpha) agonists | 4505 | 42017-89-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
metabolite of lipantyl; structure; salt of cholesterylamine & 2-(4-(p-chlorobenzoyl)phenoxy)2-methylpropionic acid
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.14 | g | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 15, 2008 | FDA | ABBVIE |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myalgia | 79.04 | 23.04 | 52 | 1951 | 146477 | 63340542 |
| Pancreatitis acute | 43.95 | 23.04 | 20 | 1983 | 27146 | 63459873 |
| Rhabdomyolysis | 29.60 | 23.04 | 18 | 1985 | 43933 | 63443086 |
| Pancreatitis | 27.78 | 23.04 | 18 | 1985 | 49037 | 63437982 |
| Blood triglycerides increased | 26.05 | 23.04 | 11 | 1992 | 12477 | 63474542 |
| Muscle spasms | 25.71 | 23.04 | 28 | 1975 | 156122 | 63330897 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myalgia | 87.38 | 27.68 | 56 | 1926 | 84054 | 34870895 |
| Low density lipoprotein increased | 76.74 | 27.68 | 22 | 1960 | 4414 | 34950535 |
| Blood triglycerides increased | 76.03 | 27.68 | 29 | 1953 | 14130 | 34940819 |
| High density lipoprotein decreased | 64.14 | 27.68 | 18 | 1964 | 3342 | 34951607 |
| Pancreatitis | 56.03 | 27.68 | 32 | 1950 | 38859 | 34916090 |
| Rash | 42.03 | 27.68 | 57 | 1925 | 222695 | 34732254 |
| Blood creatinine increased | 41.91 | 27.68 | 38 | 1944 | 94938 | 34860011 |
| Blood creatine phosphokinase increased | 39.48 | 27.68 | 27 | 1955 | 44830 | 34910119 |
| Hepatic enzyme increased | 35.52 | 27.68 | 24 | 1958 | 39056 | 34915893 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pancreatitis | 51.80 | 20.93 | 29 | 2205 | 68546 | 79673608 |
| Pancreatitis acute | 43.04 | 20.93 | 23 | 2211 | 49581 | 79692573 |
| Myalgia | 43.02 | 20.93 | 38 | 2196 | 185603 | 79556551 |
| Blood triglycerides increased | 37.46 | 20.93 | 16 | 2218 | 21024 | 79721130 |
| Blood creatinine increased | 21.45 | 20.93 | 24 | 2210 | 155033 | 79587121 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C10AB11 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Fibrates |
| MeSH PA | D000924 | Anticholesteremic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D057847 | Lipid Regulating Agents |
| FDA EPC | N0000175596 | Peroxisome Proliferator Receptor alpha Agonist |
| CHEBI has role | CHEBI:49103 | drug metabolites |
| CHEBI has role | CHEBI:83399 | marine xenobiotic metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypercholesterolemia | indication | 13644009 | |
| Hyperlipidemia | indication | 55822004 | DOID:1168 |
| Hypoalphalipoproteinemia | indication | 190785000 | |
| Familial hypercholesterolemia - heterozygous | indication | 238079002 | |
| Mixed hyperlipidemia | indication | 267434003 | |
| Hypertriglyceridemia | indication | 302870006 | |
| Agranulocytosis | contraindication | 17182001 | DOID:12987 |
| Myositis | contraindication | 26889001 | DOID:633 |
| Primary biliary cirrhosis | contraindication | 31712002 | DOID:12236 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Chronic renal failure syndrome | contraindication | 90688005 | |
| Disorder of muscle | contraindication | 129565002 | DOID:423 |
| Liver function tests abnormal | contraindication | 166603001 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Impaired renal function disorder | contraindication | 197663003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Rhabdomyolysis | contraindication | 240131006 | |
| Calculus in biliary tract | contraindication | 266474003 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.71 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7569612 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741373 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 105MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7569612 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741373 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 35MG | FIBRICOR | ATHENA | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Peroxisome proliferator-activated receptor alpha | Nuclear hormone receptor | AGONIST | Ki | 4.46 | CHEMBL | CHEMBL | |||
| Fatty acid-binding protein, intestinal | Cytosolic other | Ki | 6 | CHEMBL | |||||
| Solute carrier family 22 member 12 | Transporter | IC50 | 4.96 | CHEMBL | |||||
| Fatty acid-binding protein, liver | Unclassified | Kd | 7.03 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4BMH7IZT98 | UNII |
| D08890 | KEGG_DRUG |
| 4028374 | VANDF |
| C2586675 | UMLSCUI |
| CHEBI:83469 | CHEBI |
| F5A | PDB_CHEM_ID |
| CHEMBL1201745 | ChEMBL_ID |
| 11350701 | PUBCHEM_CID |
| CHEMBL981 | ChEMBL_ID |
| 8868 | INN_ID |
| C006012 | MESH_SUPPLEMENTAL_RECORD_UI |
| C014892 | MESH_SUPPLEMENTAL_RECORD_UI |
| 2662 | IUPHAR_LIGAND_ID |
| DB13873 | DRUGBANK_ID |
| 1433887 | RXNORM |
| 167897 | MMSL |
| 26077 | MMSL |
| d07371 | MMSL |
| 012921 | NDDF |
| 012922 | NDDF |
| 442749005 | SNOMEDCT_US |
| 442750005 | SNOMEDCT_US |
| 856676-23-8 | SECONDARY_CAS_RN |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-3161 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-3161 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-3162 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-3162 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9189 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9189 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9642 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA | 29 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9642 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1459 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1459 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1460 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1460 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1554 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1554 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1555 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 29 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1555 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 29 sections |
| FIBRICOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13310-101 | TABLET | 35 mg | ORAL | NDA | 27 sections |
| FIBRICOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13310-102 | TABLET | 105 mg | ORAL | NDA | 27 sections |
| Fenofibric AcidDelayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-109 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric AcidDelayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-109 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric AcidDelayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-112 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |
| Fenofibric AcidDelayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-112 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |
| FENOFIBRIC ACID DELAYED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42385-944 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID DELAYED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42385-944 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID DELAYED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42385-945 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID DELAYED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42385-945 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 18 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-347 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-347 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-348 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-348 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |