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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	4452	25122-46-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: clobetasol 17-propionate clofenazon clobetasol propionate	A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression. Molecular weight: 466.97 Formula: C25H32ClFO5 CLOGP: 3.49 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 80.67 ALOGS: -5.05 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

clobetasol 17-propionate
clofenazon
clobetasol propionate

A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.

Molecular weight: 466.97
Formula: C25H32ClFO5
CLOGP: 3.49
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 80.67
ALOGS: -5.05
ROTB: 5

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	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.11 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Dec. 27, 1985	FDA	FOUGERA PHARMS
Feb. 24, 2021	PMDA	Maruho Co., Ltd.

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
Psoriasis	215.64	12.97	152	10818	86805	63391247
Skin atrophy	154.82	12.97	50	10920	4856	63473196
Squamous cell carcinoma of skin	147.75	12.97	51	10919	6081	63471971
Skin exfoliation	124.82	12.97	83	10887	43019	63435033
Dry skin	89.48	12.97	76	10894	56811	63421241
Dermatitis atopic	82.25	12.97	38	10932	9686	63468366
Pruritus	75.78	12.97	182	10788	361271	63116781
Eczema	69.75	12.97	52	10918	32239	63445813
Product use in unapproved indication	68.56	12.97	116	10854	178964	63299088
Skin fissures	64.90	12.97	34	10936	11354	63466698

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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
Psoriasis	153.14	16.82	89	5616	38723	34912503
Skin exfoliation	100.47	16.82	60	5645	27372	34923854
Dermatitis atopic	95.18	16.82	35	5670	5312	34945914
Dry skin	67.08	16.82	49	5656	31238	34919988
Pruritus	65.54	16.82	97	5608	141884	34809342
Human herpesvirus 8 infection	48.86	16.82	14	5691	961	34950265
Rash	47.51	16.82	109	5596	222643	34728583
Skin fissures	43.86	16.82	20	5685	5239	34945987
Eczema	42.06	16.82	30	5675	18406	34932820
Folliculitis	30.80	16.82	15	5690	4551	34946675

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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
Psoriasis	217.12	13.94	149	12403	89438	79642398
Skin atrophy	180.48	13.94	57	12495	5661	79726175
Cushing's syndrome	149.13	13.94	34	12518	961	79730875
Squamous cell carcinoma of skin	120.93	13.94	54	12498	13979	79717857
Skin exfoliation	115.63	13.94	84	12468	55016	79676820
Dermatitis atopic	87.61	13.94	39	12513	10017	79721819
Pruritus	85.19	13.94	190	12362	394458	79337378
Skin fissures	83.79	13.94	41	12511	13032	79718804
Dry skin	79.95	13.94	74	12478	67921	79663915
Eczema	67.47	13.94	54	12498	40764	79691072

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D07AD01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, very potent (group IV)
ATC	D07CD01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, very potent, combinations with antibiotics
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:131809	smoothened receptor agonists
FDA EPC	N0000175576	Corticosteroid
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones

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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
Atopic dermatitis	indication	24079001	DOID:3310
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Nummular eczema	indication	81418003
Plaque psoriasis	indication	200965009
Scalp psoriasis	indication	238608008
Dermatosis of scalp	indication	402694007	DOID:3136
Inflammatory dermatosis	indication	703938007
Folliculitis	contraindication	13600006	DOID:4409
Glaucoma	contraindication	23986001	DOID:1686

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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	11.48	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
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10064875	Aug. 31, 2030	PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10064875	Aug. 31, 2030	TREATMENT OF MODERATE PLAQUE PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10064875	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10064875	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10064875	Aug. 31, 2030	TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	10588914	Aug. 31, 2030	TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	9956231	Aug. 31, 2030	PLAQUE PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	9956231	Aug. 31, 2030	PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	9956231	Aug. 31, 2030	TREATMENT OF MODERATE PLAQUE PSORIASIS
0.025%	IMPOYZ	PRIMUS PHARMS	N209483	Nov. 28, 2017	RX	CREAM	TOPICAL	9956231	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS

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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
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	Ki	9.18	DRUG MATRIX	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN		IC50	5.07	CHEMBL
Cytochrome P450 3A5	Enzyme	P20815	CP3A5_HUMAN		IC50	7.68	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	5.60	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.82	DRUG MATRIX
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	8.50	CHEMBL
Bile salt export pump	Transporter		ABCBB_RAT		IC50	4.46	CHEMBL

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External reference:

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ID	Source
XRD	PDB_CHEM_ID
002203	NDDF
004480	NDDF
21245	RXNORM
25122-41-2	SECONDARY_CAS_RN
300	MMSL
3154	INN_ID
32197004	SNOMEDCT_US
32798	PUBCHEM_CID
4018898	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0162	OINTMENT	0.50 mg	TOPICAL	ANDA	20 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0163	CREAM	0.50 mg	TOPICAL	ANDA	20 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0269	SOLUTION	0.50 mg	TOPICAL	ANDA	18 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0293	GEL	0.50 mg	TOPICAL	ANDA	20 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8055	AEROSOL, FOAM	0.50 mg	TOPICAL	NDA authorized generic	27 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8055	AEROSOL, FOAM	0.50 mg	TOPICAL	NDA authorized generic	27 sections
clobetasol propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8167	AEROSOL, FOAM	0.50 mg	TOPICAL	NDA authorized generic	26 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0400	CREAM	0.50 mg	TOPICAL	ANDA	19 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0402	SOLUTION	0.50 mg	TOPICAL	ANDA	13 sections
Clobetasol Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0403	SHAMPOO	0.05 g	TOPICAL	ANDA	18 sections

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