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

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	465	112965-21-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: calcipotriene calcipotriol calciptriol daivonex dovonex calcipotriene hydrate calcipotriol hydrate	a topical dermatologic for the treatment of moderate plaque psoriasis Molecular weight: 412.61 Formula: C27H40O3 CLOGP: 5.27 LIPINSKI: 1 HAC: 3 HDO: 3 TPSA: 60.69 ALOGS: -4.49 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

calcipotriene
calcipotriol
calciptriol
daivonex
dovonex
calcipotriene hydrate
calcipotriol hydrate

a topical dermatologic for the treatment of moderate plaque psoriasis

Molecular weight: 412.61
Formula: C27H40O3
CLOGP: 5.27
LIPINSKI: 1
HAC: 3
HDO: 3
TPSA: 60.69
ALOGS: -4.49
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
BA (Bioavailability)	5.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1993	FDA

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	1044.19	22.96	409	8598	86548	63393467
Skin haemorrhage	247.65	22.96	81	8926	10013	63470002
Skin exfoliation	235.12	22.96	117	8890	42985	63437030
Neurologic neglect syndrome	198.60	22.96	51	8956	2670	63477345
Carotid artery thrombosis	197.26	22.96	51	8956	2743	63477272
Personality disorder	160.34	22.96	51	8956	5760	63474255
Sinus congestion	154.25	22.96	67	8940	18056	63461959
Adjustment disorder	153.54	22.96	43	8964	3135	63476880
Respiratory tract congestion	148.75	22.96	65	8942	17767	63462248
Sneezing	144.19	22.96	64	8943	18154	63461861

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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	557.28	22.13	197	3843	38615	34914276
Psoriatic arthropathy	148.62	22.13	63	3977	19735	34933156
Drug ineffective	108.52	22.13	190	3850	456561	34496330
Skin exfoliation	64.74	22.13	40	4000	27392	34925499
Skin plaque	49.47	22.13	19	4021	4595	34948296
Guttate psoriasis	42.02	22.13	9	4031	261	34952630
Product dose omission issue	40.66	22.13	59	3981	119652	34833239
Malignant melanoma stage I	38.08	22.13	7	4033	90	34952801
Keratoacanthoma	34.16	22.13	9	4031	641	34952250
Papule	30.43	22.13	13	4027	4126	34948765

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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	1155.20	20.95	433	9880	89154	79644921
Skin haemorrhage	241.34	20.95	81	10232	11900	79722175
Skin exfoliation	215.33	20.95	116	10197	54984	79679091
Neurologic neglect syndrome	195.01	20.95	50	10263	2857	79731218
Carotid artery thrombosis	192.58	20.95	50	10263	3003	79731072
Psoriatic arthropathy	160.99	20.95	109	10204	77890	79656185
Personality disorder	158.00	20.95	50	10263	6096	79727979
Sinus congestion	150.91	20.95	66	10247	19830	79714245
Sneezing	145.10	20.95	64	10249	19619	79714456
Respiratory tract congestion	144.26	20.95	64	10249	19890	79714185

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D05AX02	DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use
ATC	D05AX52	DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use
CHEBI has role	CHEBI:50748	antipsoriatic drug
CHEBI has role	CHEBI:88188	allergenic drug
FDA CS	M0022797	Vitamin D
FDA EPC	N0000175849	Vitamin D Analog
MeSH PA	D003879	Dermatologic 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
Plaque psoriasis	indication	200965009
Scalp psoriasis	indication	238608008
Psoriasis	off-label use	9014002	DOID:8893
Congenital ichthyosis of skin	contraindication	13059002
Hypervitaminosis D	contraindication	27712000	DOID:9971
Guttate psoriasis	contraindication	37042000
Hypercalcemia	contraindication	66931009	DOID:12678
Disorder of calcium metabolism	contraindication	71638002	DOID:10575
Hypercalciuria	contraindication	71938000
Pustular psoriasis	contraindication	200973000

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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	13.7	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
0.005%	SORILUX	MAYNE PHARMA	N022563	Oct. 6, 2010	RX	AEROSOL, FOAM	TOPICAL	8629128	May 26, 2026	USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
0.005%	SORILUX	MAYNE PHARMA	N022563	Oct. 6, 2010	RX	AEROSOL, FOAM	TOPICAL	8629128	May 26, 2026	USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 18 YEARS AND OLDER
0.005%	SORILUX	MAYNE PHARMA	N022563	Oct. 6, 2010	RX	AEROSOL, FOAM	TOPICAL	8629128	May 26, 2026	USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER
0.005%	SORILUX	MAYNE PHARMA	N022563	Oct. 6, 2010	RX	AEROSOL, FOAM	TOPICAL	8263580	May 7, 2028	USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
0.005%	SORILUX	MAYNE PHARMA	N022563	Oct. 6, 2010	RX	AEROSOL, FOAM	TOPICAL	8263580	May 7, 2028	USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	10660908	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	10688108	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	9119781	June 10, 2031	PLAQUE PSORIASIS
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	9119781	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

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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
0.064%;0.005%	TACLONEX	LEO PHARMA AS	N022185	May 9, 2008	RX	SUSPENSION	TOPICAL	Jan. 25, 2023	PEDIATRIC EXCLUSIVITY
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	Jan. 30, 2023	PEDIATRIC EXCLUSIVITY
0.064%;0.005%	WYNZORA	MC2	N213422	July 20, 2020	RX	CREAM	TOPICAL	July 20, 2023	NEW DOSAGE FORM

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST	Kd	9.51		CHEMBL	CHEMBL

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External reference:

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ID	Source
MC9	PDB_CHEM_ID
003941	NDDF
017139	NDDF
126232005	SNOMEDCT_US
1299898	RXNORM
136766	MMSL
143NQ3779B	UNII
147657-22-5	SECONDARY_CAS_RN
2778	IUPHAR_LIGAND_ID
368	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1475	SOLUTION	0.05 mg	TOPICAL	ANDA	14 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0400	SOLUTION	0.05 mg	TOPICAL	ANDA	20 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0318	SOLUTION	0.05 mg	TOPICAL	ANDA	14 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0318	SOLUTION	0.05 mg	TOPICAL	ANDA	14 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0781-7117	CREAM	0.05 mg	TOPICAL	ANDA	19 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	0781-7117	CREAM	0.05 mg	TOPICAL	ANDA	19 sections
calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	16714-763	CREAM	50 ug	TOPICAL	ANDA	20 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	40032-043	SOLUTION	0.05 mg	TOPICAL	ANDA	18 sections
calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51407-605	CREAM	50 ug	TOPICAL	ANDA	20 sections
calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51407-605	CREAM	50 ug	TOPICAL	ANDA	20 sections

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