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capsaicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
analgesics, capsaicin analogues	3064	404-86-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: capsaicin capsaicine qutenza NGX-4010 NGX 4010	An alkylamide found in CAPSICUM that acts at TRPV CATION CHANNELS. Molecular weight: 305.42 Formula: C18H27NO3 CLOGP: 3.75 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 58.56 ALOGS: -4.56 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

capsaicin
capsaicine
qutenza
NGX-4010
NGX 4010

An alkylamide found in CAPSICUM that acts at TRPV CATION CHANNELS.

Molecular weight: 305.42
Formula: C18H27NO3
CLOGP: 3.75
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 58.56
ALOGS: -4.56
ROTB: 9

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.06 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Nov. 16, 2009	FDA	ACORDA

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
Application site pain	286.83	16.72	72	7501	4110	63477339
Body tinea	188.52	16.72	44	7529	1841	63479608
Inhibitory drug interaction	165.60	16.72	43	7530	2806	63478643
Infection susceptibility increased	161.22	16.72	44	7529	3477	63477972
Application site erythema	138.79	16.72	42	7531	4793	63476656
Glucose tolerance impaired	134.09	16.72	44	7529	6533	63474916
Application site burn	118.86	16.72	26	7547	808	63480641
Poor quality sleep	114.06	16.72	53	7520	19882	63461567
Purpura	114.01	16.72	45	7528	11340	63470109
Impaired quality of life	109.02	16.72	46	7527	13737	63467712

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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
Application site pain	234.12	20.67	48	2447	1860	34952576
Application site erythema	100.55	20.67	25	2470	2311	34952125
Burning sensation	41.41	20.67	22	2473	18372	34936064
Application site burn	35.48	20.67	7	2488	221	34954215
Application site vesicles	33.61	20.67	8	2487	614	34953822
Application site necrosis	31.96	20.67	4	2491	3	34954433
Swollen tongue	28.78	20.67	16	2479	14589	34939847
Pain	27.64	20.67	51	2444	204624	34749812
Sleep deficit	23.86	20.67	6	2489	579	34953857
Anticholinergic syndrome	23.53	20.67	7	2488	1262	34953174

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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
Application site pain	364.61	16.95	87	8138	4660	79731503
Body tinea	190.17	16.95	43	8182	1811	79734352
Application site erythema	178.30	16.95	50	8175	5060	79731103
Infection susceptibility increased	160.41	16.95	43	8182	3678	79732485
Inhibitory drug interaction	148.23	16.95	42	8183	4411	79731752
Application site burn	138.54	16.95	29	8196	846	79735317
Glucose tolerance impaired	127.49	16.95	43	8182	8041	79728122
Impaired quality of life	110.14	16.95	45	8180	14341	79721822
Poor quality sleep	108.58	16.95	51	8174	22671	79713492
Bone density decreased	106.47	16.95	43	8182	13304	79722859

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M02AB01	MUSCULO-SKELETAL SYSTEM TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN Capsaicin and similar agents
ATC	N01BX04	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Other local anesthetics
CHEBI has role	CHEBI:38634	voltage-dependent sodium channel blockers
CHEBI has role	CHEBI:140535	capsaicin receptor agonist
MeSH PA	D000982	Antipruritics
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System 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
Postherpetic neuralgia	indication	2177002
Neuralgia	indication	16269008
Backache	indication	161891005
Arthritic Pain	indication
Sprains and Strains	indication
Cannabis hyperemesis syndrome co-occurrent and due to cannabis abuse	off-label use	11047881000119100
Cannabis hyperemesis syndrome co-occurrent and due to cannabis dependence	off-label use	11048011000119100
Gastritis	contraindication	4556007	DOID:4029
Bacterial septicemia	contraindication	10001005	DOID:0040085
Myocardial infarction	contraindication	22298006	DOID:5844

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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	8.64	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
8%	QUTENZA	AVERITAS	N022395	Nov. 16, 2009	RX	PATCH	TOPICAL	8263059	Sept. 5, 2023	METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA
8%	QUTENZA	AVERITAS	N022395	Nov. 16, 2009	RX	PATCH	TOPICAL	8889113	Sept. 5, 2023	METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
8%	QUTENZA	AVERITAS	N022395	Nov. 16, 2009	RX	PATCH	TOPICAL	July 17, 2023	TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) OF THE FEET

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Transient receptor potential cation channel subfamily V member 1	Ion channel	Q8NER1	TRPV1_HUMAN	OPENER	Ki	8.22	CHEMBL	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN		IC50	5.42	CHEMBL
Cytochrome P450 1A2	Enzyme	P05177	CP1A2_HUMAN		IC50	5.52	DRUG MATRIX
Arachidonate 5-lipoxygenase	Enzyme	P09917	LOX5_HUMAN		IC50	4.25	CHEMBL
Potassium voltage-gated channel subfamily A member 1	Ion channel	Q09470	KCNA1_HUMAN		IC50	4.54	CHEMBL
Tyrosine--tRNA ligase, cytoplasmic	Enzyme	P54577	SYYC_HUMAN		Ki	4.38	CHEMBL
Lysine-specific histone demethylase 1A	Enzyme	O60341	KDM1A_HUMAN		IC50	6.22	CHEMBL
Transient receptor potential cation channel subfamily V member 1	Ion channel		TRPV1_RAT		Ki	5.77	CHEMBL
NADH-ubiquinone oxidoreductase chain 1	Unclassified		NU1M_BOVIN		IC50	4.28	CHEMBL
Transient receptor potential cation channel subfamily M member 8	Ion channel		TRPM8_MOUSE		IC50	4.55	CHEMBL

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External reference:

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ID	Source
4DY	PDB_CHEM_ID
001988	NDDF
10145	INN_ID
1548943	PUBCHEM_CID
169226	MMSL
1992	RXNORM
2486	IUPHAR_LIGAND_ID
400416009	SNOMEDCT_US
4019506	VUID
4019506	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ASTRAPHARM CHILLI BRAND	HUMAN OTC DRUG LABEL	1	11993-000	PLASTER	0.25 g	TOPICAL	OTC monograph not final	14 sections
ASTRAPHARM CHILLI BRAND	HUMAN OTC DRUG LABEL	1	11993-000	PLASTER	0.25 g	TOPICAL	OTC monograph not final	14 sections
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED	HUMAN OTC DRUG LABEL	1	11993-001	PLASTER	70 mg	TOPICAL	OTC monograph not final	13 sections
BLUE SPRING Foot and Leg Comfort Cream with Pain Relief	HUMAN OTC DRUG LABEL	2	14448-316	CREAM	0.25 mg	TOPICAL	OTC monograph not final	13 sections
Capsaicin	HUMAN OTC DRUG LABEL	1	11822-7884	CREAM	0.00 g	TOPICAL	OTC monograph not final	12 sections
Capsaicin	HUMAN OTC DRUG LABEL	1	11822-7884	CREAM	0.00 g	TOPICAL	OTC monograph not final	12 sections
Capsaicin	HUMAN OTC DRUG LABEL	1	11822-7884	CREAM	0.00 g	TOPICAL	OTC monograph not final	12 sections
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	HUMAN OTC DRUG LABEL	1	0363-9902	PATCH	0.03 g	TOPICAL	OTC monograph not final	13 sections
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	HUMAN OTC DRUG LABEL	1	0363-9902	PATCH	0.03 g	TOPICAL	OTC monograph not final	13 sections
CAPSAICIN HEAT PATCHES PAIN RELIEF	HUMAN OTC DRUG LABEL	1	11822-4210	PATCH	0.03 g	TOPICAL	OTC monograph not final	14 sections

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