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

Stem definitionDrug idCAS RN
Vitamin D analogues/derivatives 465 112965-21-6

Description:

MoleculeDescription

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:

PropertyValueReference
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:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Vitamin D3 receptor Nuclear hormone receptor AGONIST Kd 9.51 CHEMBL CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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