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:

Property	Value	Reference
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
BA (Bioavailability)	5.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1993	FDA

FDA Adverse Event Reporting System (Female)

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
Hemiplegia	136.72	22.96	51	8956	9272	63470743
Sensory loss	135.65	22.96	52	8955	10186	63469829
Sinus disorder	131.85	22.96	66	8941	24487	63455528
Affect lability	131.34	22.96	52	8955	11099	63468916
Motor dysfunction	129.61	22.96	51	8956	10710	63469305
Coordination abnormal	120.73	22.96	52	8955	13721	63466294
Psoriatic arthropathy	113.47	22.96	98	8909	91422	63388593
Rhinorrhoea	99.56	22.96	79	8928	65498	63414517
Skin plaque	95.18	22.96	38	8969	8282	63471733
Muscle spasticity	95.18	22.96	51	8956	21743	63458272
Hemiparesis	92.02	22.96	51	8956	23231	63456784
Cystitis	91.61	22.96	70	8937	54921	63425094
Eating disorder	87.27	22.96	46	8961	18970	63461045
Influenza like illness	83.68	22.96	72	8935	66752	63413263
Aphasia	75.60	22.96	51	8956	32949	63447066
Diabetes mellitus inadequate control	73.43	22.96	38	8969	15088	63464927
Arterial occlusive disease	70.90	22.96	28	8979	5930	63474085
Gangrene	70.15	22.96	28	8979	6095	63473920
Influenza	69.00	22.96	81	8926	108641	63371374
Dysarthria	68.12	22.96	53	8954	42658	63437357
Infected dermal cyst	55.71	22.96	13	8994	454	63479561
Blood pressure inadequately controlled	47.60	22.96	20	8987	4958	63475057
Nasopharyngitis	45.70	22.96	107	8900	254150	63225865
Pain of skin	44.63	22.96	25	8982	11609	63468406
Pruritus	43.50	22.96	131	8876	361322	63118693
Dysphagia	41.86	22.96	57	8950	88528	63391487
Drug ineffective	41.60	22.96	271	8736	1044494	62435521
Multiple drug therapy	39.44	22.96	16	8991	3630	63476385
Exercise tolerance decreased	39.30	22.96	18	8989	5479	63474536
Gallbladder rupture	35.67	22.96	9	8998	438	63479577
Malaise	34.40	22.96	133	8874	415821	63064194
Cerebrovascular accident	33.30	22.96	57	8950	107967	63372048
Pulmonary congestion	33.06	22.96	24	8983	17394	63462621
Headache	32.61	22.96	176	8831	633065	62846950
Angina pectoris	30.88	22.96	29	8978	30049	63449966
Gastric disorder	30.87	22.96	32	8975	37337	63442678
Muscular weakness	29.42	22.96	58	8949	122295	63357720
Secretion discharge	25.86	22.96	18	8989	12213	63467802
Seborrhoeic keratosis	24.38	22.96	10	8997	2332	63477683
Anxiety	24.38	22.96	77	8930	217464	63262551
Arthritis	23.23	22.96	51	8956	115870	63364145

FDA Adverse Event Reporting System (Male)

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
Meningitis aseptic	30.06	22.13	12	4028	3212	34949679
Hyperkeratosis	28.31	22.13	12	4028	3737	34949154
Panic attack	28.10	22.13	16	4024	9416	34943475
Nasopharyngitis	27.46	22.13	37	4003	69931	34882960
Rash	27.03	22.13	71	3969	222681	34730210
Dermatitis	25.39	22.13	15	4025	9453	34943438
Arthralgia	23.52	22.13	57	3983	169984	34782907
Superficial spreading melanoma stage unspecified	22.41	22.13	5	4035	176	34952715
Malignant melanoma	22.17	22.13	13	4027	8077	34944814

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
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
Adjustment disorder	143.27	20.95	42	10271	3958	79730117
Sinus disorder	143.23	20.95	66	10247	22398	79711677
Affect lability	128.38	20.95	50	10263	11209	79722866
Sensory loss	124.86	20.95	51	10262	12940	79721135
Hemiplegia	117.99	20.95	51	10262	14888	79719187
Motor dysfunction	115.39	20.95	50	10263	14683	79719392
Coordination abnormal	110.77	20.95	51	10262	17261	79716814
Rhinorrhoea	108.40	20.95	85	10228	75989	79658086
Muscle spasticity	97.41	20.95	50	10263	21425	79712650
Cystitis	95.38	20.95	68	10245	52664	79681411
Eating disorder	87.60	20.95	46	10267	20651	79713424
Influenza like illness	78.93	20.95	69	10244	71638	79662437
Nasopharyngitis	78.06	20.95	127	10186	253754	79480321
Hemiparesis	76.41	20.95	50	10263	33683	79700392
Skin plaque	72.97	20.95	33	10280	10712	79723363
Influenza	71.63	20.95	86	10227	129520	79604555
Aphasia	66.06	20.95	52	10261	46680	79687395
Arterial occlusive disease	60.70	20.95	27	10286	8429	79725646
Diabetes mellitus inadequate control	59.97	20.95	38	10275	24226	79709849
Malaise	59.73	20.95	168	10145	489701	79244374
Gangrene	56.06	20.95	26	10287	8938	79725137
Secretion discharge	48.68	20.95	28	10285	14994	79719081
Dysarthria	47.76	20.95	51	10262	67571	79666504
Pulmonary congestion	44.55	20.95	33	10280	27067	79707008
Panic attack	43.23	20.95	31	10282	24185	79709890
Blood pressure inadequately controlled	42.03	20.95	19	10294	6158	79727917
Infected dermal cyst	39.78	20.95	12	10301	1246	79732829
Pain of skin	38.91	20.95	24	10289	14589	79719486
Drug ineffective	38.73	20.95	255	10058	1080658	78653417
Pulmonary mass	38.23	20.95	31	10282	29003	79705072
Guttate psoriasis	36.10	20.95	9	10304	458	79733617
Multiple drug therapy	35.76	20.95	15	10298	4063	79730012
Gastric disorder	35.22	20.95	33	10280	37400	79696675
Headache	34.36	20.95	171	10142	653601	79080474
Malignant melanoma stage I	34.10	20.95	7	10306	146	79733929
Anxiety	31.92	20.95	87	10226	248425	79485650
Erythrodermic psoriasis	31.90	20.95	11	10302	1747	79732328
Movement disorder	31.52	20.95	27	10286	27232	79706843
Dysphagia	30.75	20.95	56	10257	122080	79611995
Exercise tolerance decreased	29.64	20.95	17	10296	9054	79725021
Gallbladder rupture	29.48	20.95	9	10304	973	79733102
Keratoacanthoma	28.93	20.95	9	10304	1036	79733039
Cerebrovascular accident	28.06	20.95	62	10251	155230	79578845
Acute kidney injury	26.94	20.95	17	10296	519387	79214688
Arthritis	23.20	20.95	48	10265	114832	79619243
Death	22.60	20.95	24	10289	566490	79167585
Thyroglossal cyst infection	22.51	20.95	4	10309	37	79734038
Serum procollagen type III N-terminal propeptide increased	21.56	20.95	4	10309	48	79734027
Pain	21.51	20.95	160	10153	703642	79030433
Hyperkeratosis	21.26	20.95	13	10300	7777	79726298
Drug interaction	20.95	20.95	14	10299	415169	79318906

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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
FDA CS	M0022797	Vitamin D
MeSH PA	D003879	Dermatologic Agents
FDA EPC	N0000175849	Vitamin D Analog
CHEBI has role	CHEBI:50748	antipsoriatic drug
CHEBI has role	CHEBI:88188	allergenic drug

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

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
Telangiectasia disorder	contraindication	247479008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006

🐶 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)

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

Orange Book exclusivity data (new drug applications)

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

Bioactivity Summary:

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

External reference:

ID	Source
4020856	VUID
N0000148363	NUI
D01125	KEGG_DRUG
1299898	RXNORM
C0065767	UMLSCUI
CHEBI:50749	CHEBI
MC9	PDB_CHEM_ID
CHEMBL1200666	ChEMBL_ID
DB02300	DRUGBANK_ID
C055085	MESH_SUPPLEMENTAL_RECORD_UI
2778	IUPHAR_LIGAND_ID
6376	INN_ID
143NQ3779B	UNII
5288783	PUBCHEM_CID
136766	MMSL
368	MMSL
4322	MMSL
126232005	SNOMEDCT_US
395766004	SNOMEDCT_US
726717009	SNOMEDCT_US
4020856	VANDF
147657-22-5	SECONDARY_CAS_RN
003941	NDDF
017139	NDDF

Pharmaceutical products:

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 AND BETAMETHASONE DIPROPIONATE	HUMAN PRESCRIPTION DRUG LABEL	2	0781-7165	OINTMENT	50 ug	TOPICAL	ANDA	22 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 and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	45802-816	OINTMENT	50 ug	TOPICAL	ANDA	24 sections
Calcipotriene and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	45802-816	OINTMENT	50 ug	TOPICAL	ANDA	24 sections
Dovonex	HUMAN PRESCRIPTION DRUG LABEL	1	50222-260	CREAM	50 ug	TOPICAL	NDA	21 sections
Dovonex	HUMAN PRESCRIPTION DRUG LABEL	1	50222-260	CREAM	50 ug	TOPICAL	NDA	21 sections
Dovonex	HUMAN PRESCRIPTION DRUG LABEL	1	50222-260	CREAM	50 ug	TOPICAL	NDA	21 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
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51407-606	OINTMENT	50 ug	TOPICAL	ANDA	22 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51407-606	OINTMENT	50 ug	TOPICAL	ANDA	22 sections
Calcipotriene and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	51672-1402	SUSPENSION	50 ug	TOPICAL	ANDA	29 sections
Calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4154	OINTMENT	0.05 mg	TOPICAL	ANDA	21 sections
Calcitrene	HUMAN PRESCRIPTION DRUG LABEL	1	51672-5278	OINTMENT	0.05 mg	TOPICAL	ANDA	21 sections
SORILUX	HUMAN PRESCRIPTION DRUG LABEL	1	51862-376	AEROSOL, FOAM	50 ug	TOPICAL	NDA	29 sections
SORILUX	HUMAN PRESCRIPTION DRUG LABEL	1	51862-376	AEROSOL, FOAM	50 ug	TOPICAL	NDA	29 sections
calcipotriene	HUMAN PRESCRIPTION DRUG LABEL	1	51862-512	AEROSOL, FOAM	50 ug	TOPICAL	NDA	29 sections
Dovonex	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4725	CREAM	50 ug	TOPICAL	NDA	20 sections
Dovonex	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6057	SOLUTION	0.05 mg	TOPICAL	NDA	13 sections
Taclonex Scalp	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6091	SUSPENSION	50 ug	TOPICAL	NDA	26 sections
Calcipotriene and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	63629-2520	OINTMENT	50 ug	TOPICAL	ANDA	24 sections
Calcipotriene and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	63629-2520	OINTMENT	50 ug	TOPICAL	ANDA	24 sections
Calcipotriene and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	63629-8617	OINTMENT	50 ug	TOPICAL	ANDA	24 sections