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choline fenofibrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.114 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 2.089 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 82.414 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 4.188 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 1.030 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 1.870 | % | High | 1 |
| herg | hERG pIC50 | 4.357 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.550 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.162 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.800 | % | High | 1 |
| kinase-safety-class | ACVR2B,AURKA,AXL,BRAF,BTK,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,IKBKB,MAP2K6,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,TEK,TGFBR1 | 22 | |||
| kinase-selectivity-class | ACVR2B,EIF2AK3,GRK2,MAP2K6,PDK4 | 5 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.955 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 12.764 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 4.150 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.585 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | Moderate | 0.68 | |
| pppb | Pig plasma protein binding (% unbound) | 1.270 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 5.943 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 80.720 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.890 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 903.649 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 15, 2008 | FDA | ABBVIE |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
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 | 24.25 | 23.93 | 15 | 1394 | 93518 | 110494372 |
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 | D000960 | Hypolipidemic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D057847 | Lipid Regulating Agents |
| FDA EPC | N0000175596 | Peroxisome Proliferator Receptor alpha Agonist |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:49103 | drug metabolite |
| CHEBI has role | CHEBI:83399 | marine xenobiotic metabolite |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35821 | anticholesteremic drug |
Related Drugs by ATC class:
C10AB Fibrates 11 drugs
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 | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7569612 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 105MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741373 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 105MG | FIBRICOR | ROSEMONT | 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 | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 105MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 105MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 105MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 35MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7569612 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 35MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741373 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA |
| 35MG | FIBRICOR | ROSEMONT | 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 | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7741374 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 35MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS |
| 35MG | FIBRICOR | ROSEMONT | N022418 | Aug. 14, 2009 | DISCN | TABLET | ORAL | 7915247 | Aug. 20, 2027 | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA |
| 35MG | FIBRICOR | ROSEMONT | 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 | Cytosolic other | Kd | 7.03 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4BMH7IZT98 | UNII |
| D08890 | KEGG_DRUG |
| 4028374 | VANDF |
| C2586675 | UMLSCUI |
| CHEBI:749591 | CHEBI |
| CHEMBL1201745 | ChEMBL_ID |
| 11350701 | PUBCHEM_CID |
| CHEMBL981 | ChEMBL_ID |
| 8868 | INN_ID |
| C006012 | MESH_SUPPLEMENTAL_RECORD_UI |
| C014892 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13873 | DRUGBANK_ID |
| 1433887 | RXNORM |
| 167897 | MMSL |
| 26077 | MMSL |
| d07371 | MMSL |
| 012921 | NDDF |
| 012922 | NDDF |
| 374531000221105 | SNOMEDCT_US |
| 442749005 | SNOMEDCT_US |
| 442750005 | SNOMEDCT_US |
| F5A | PDB_CHEM_ID |
| 2662 | IUPHAR_LIGAND_ID |
| 856676-23-8 | SECONDARY_CAS_RN |
| 4BMH7IZT98 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1324 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1325 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1554 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | NDA authorized generic | 30 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1555 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 30 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 acid | Human Prescription Drug Label | 1 | 33342-294 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 26 sections |
| Fenofibric acid | Human Prescription Drug Label | 1 | 33342-295 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 26 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 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-347 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 26 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-348 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 26 sections |
| Fenofibric Acid | Human Prescription Drug Label | 1 | 46708-244 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 26 sections |
| Fenofibric Acid | Human Prescription Drug Label | 1 | 46708-245 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 26 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4373 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 27 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4561 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA authorized generic | 27 sections |
| Trilipix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5986 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | NDA | 26 sections |
| FENOFIBRIC ACID | Human Prescription Drug Label | 1 | 59651-216 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 26 sections |
| FENOFIBRIC ACID | Human Prescription Drug Label | 1 | 59651-217 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 26 sections |
| Fenofibric Acid | Human Prescription Drug Label | 1 | 62332-244 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 26 sections |
| Fenofibric Acid | Human Prescription Drug Label | 1 | 62332-245 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 26 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68134-601 | TABLET | 35 mg | ORAL | NDA authorized generic | 26 sections |
| Fenofibric Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68134-602 | TABLET | 105 mg | ORAL | NDA authorized generic | 26 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-128 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 25 sections |
| Fenofibric acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-129 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 25 sections |
| FENOFIBRIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69315-281 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69315-281 | CAPSULE, DELAYED RELEASE | 45 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69315-282 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 18 sections |
| FENOFIBRIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69315-282 | CAPSULE, DELAYED RELEASE | 135 mg | ORAL | ANDA | 18 sections |
| FIBRICOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69916-035 | TABLET | 35 mg | ORAL | NDA | 27 sections |