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
Molfile Inchi Smiles Synonyms: choline fenofibrate fenofibric acid procetofenic acid	metabolite of lipantyl; structure; salt of cholesterylamine & 2-(4-(p-chlorobenzoyl)phenoxy)2-methylpropionic acid Molecular weight: 318.75 Formula: C17H15ClO4 CLOGP: 4.07 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 63.60 ALOGS: -4.80 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

choline fenofibrate
fenofibric acid
procetofenic acid

metabolite of lipantyl; structure; salt of cholesterylamine & 2-(4-(p-chlorobenzoyl)phenoxy)2-methylpropionic acid

Molecular weight: 318.75
Formula: C17H15ClO4
CLOGP: 4.07
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 63.60
ALOGS: -4.80
ROTB: 5

Status: OFP

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)

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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

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FDA Adverse Event Reporting System (Male)

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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

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FDA Adverse Event Reporting System (Geriatric)

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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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C10AB11	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Fibrates
CHEBI has role	CHEBI:49103	drug metabolites
CHEBI has role	CHEBI:83399	marine xenobiotic metabolites
FDA EPC	N0000175596	Peroxisome Proliferator Receptor alpha Agonist
MeSH PA	D000924	Anticholesteremic Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000960	Hypolipidemic Agents
MeSH PA	D057847	Lipid Regulating Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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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

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🐶 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)

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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

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Peroxisome proliferator-activated receptor alpha	Nuclear hormone receptor	Q07869	PPARA_HUMAN	AGONIST	Ki	4.46	CHEMBL	CHEMBL
Fatty acid-binding protein, intestinal	Cytosolic other	P12104	FABPI_HUMAN		Ki	6	CHEMBL
Solute carrier family 22 member 12	Transporter	Q96S37	S22AC_HUMAN		IC50	4.96	CHEMBL
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Kd	7.03	CHEMBL

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External reference:

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ID	Source
012921	NDDF
012922	NDDF
11350701	PUBCHEM_CID
1433887	RXNORM
167897	MMSL
26077	MMSL
2662	IUPHAR_LIGAND_ID
4028374	VANDF
442749005	SNOMEDCT_US
442750005	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
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

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