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 904.71 22.33 339 6337 68661 50529787
Skin haemorrhage 163.39 22.33 53 6623 6865 50591583
Psoriatic arthropathy 113.50 22.33 73 6603 46959 50551489
Skin exfoliation 111.55 22.33 64 6612 33548 50564900
Neurologic neglect syndrome 87.26 22.33 23 6653 1435 50597013
Carotid artery thrombosis 86.63 22.33 23 6653 1476 50596972
Sinus congestion 85.05 22.33 40 6636 13931 50584517
Respiratory tract congestion 78.35 22.33 38 6638 14161 50584287
Diabetes mellitus inadequate control 78.06 22.33 37 6639 13108 50585340
Sneezing 75.73 22.33 37 6639 14007 50584441
Sinus disorder 68.94 22.33 38 6638 18420 50580028
Adjustment disorder 66.67 22.33 20 6656 1999 50596449
Personality disorder 62.64 22.33 23 6653 4301 50594147
Infected dermal cyst 57.01 22.33 13 6663 441 50598007
Rhinorrhoea 54.67 22.33 49 6627 51534 50546914
Sensory loss 52.84 22.33 24 6652 7714 50590734
Hemiplegia 50.74 22.33 23 6653 7358 50591090
Affect lability 49.38 22.33 24 6652 8974 50589474
Motor dysfunction 48.88 22.33 23 6653 8008 50590440
Cystitis 48.54 22.33 43 6633 44521 50553927
Blood pressure inadequately controlled 47.97 22.33 19 6657 4361 50594087
Skin plaque 47.59 22.33 21 6655 6307 50592141
Multiple drug therapy 46.36 22.33 15 6661 1922 50596526
Coordination abnormal 43.76 22.33 24 6652 11510 50586938
Influenza like illness 42.84 22.33 45 6631 57414 50541034
Exercise tolerance decreased 39.34 22.33 17 6659 4857 50593591
Influenza 38.50 22.33 53 6623 89485 50508963
Pruritus 38.04 22.33 102 6574 283466 50314982
Eating disorder 37.32 22.33 24 6652 15385 50583063
Pulmonary congestion 35.09 22.33 23 6653 15224 50583224
Nasopharyngitis 33.89 22.33 77 6599 192850 50405598
Headache 33.06 22.33 143 6533 506392 50092056
Muscle spasticity 32.59 22.33 23 6653 17161 50581287
Gallbladder rupture 32.43 22.33 8 6668 382 50598066
Hemiparesis 29.42 22.33 23 6653 20025 50578423
Malaise 29.37 22.33 104 6572 335428 50263020
Secretion discharge 28.12 22.33 17 6659 9774 50588674
Burning sensation 25.98 22.33 31 6645 45415 50553033
Pulmonary mass 24.34 22.33 20 6656 18685 50579763
Pain of skin 23.35 22.33 14 6662 7933 50590515
Stress 23.34 22.33 32 6644 53761 50544687
Skin discolouration 23.24 22.33 25 6651 32732 50565716
Irritability 22.49 22.33 23 6653 28403 50570045
Aphasia 22.45 22.33 23 6653 28471 50569977
Thyroglossal cyst infection 22.33 22.33 4 6672 38 50598410

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 528.47 23.29 178 3056 32049 29539244
Psoriatic arthropathy 96.93 23.29 42 3192 14649 29556644
Guttate psoriasis 40.93 23.29 8 3226 154 29571139
Malignant melanoma stage I 38.76 23.29 7 3227 86 29571207
Product dose omission issue 37.07 23.29 49 3185 96334 29474959
Keratoacanthoma 35.88 23.29 9 3225 558 29570735
Skin exfoliation 35.36 23.29 25 3209 22620 29548673
Drug ineffective 33.58 23.29 101 3133 363069 29208224
Nasopharyngitis 32.15 23.29 36 3198 59629 29511664
Panic attack 30.81 23.29 16 3218 8310 29562983
Hyperkeratosis 30.54 23.29 12 3222 3257 29568036
Secretion discharge 24.39 23.29 11 3223 4199 29567094

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 1031.98 20.10 372 7675 71331 64419354
Skin haemorrhage 158.94 20.10 54 7993 8531 64482154
Psoriatic arthropathy 146.84 20.10 82 7965 43199 64447486
Skin exfoliation 130.74 20.10 77 7970 44808 64445877
Neurologic neglect syndrome 86.15 20.10 23 8024 1595 64489090
Carotid artery thrombosis 83.79 20.10 23 8024 1772 64488913
Sinus congestion 83.35 20.10 40 8007 15399 64475286
Sneezing 77.77 20.10 38 8009 15213 64475472
Sinus disorder 76.96 20.10 39 8008 16869 64473816
Respiratory tract congestion 75.67 20.10 38 8009 16127 64474558
Rhinorrhoea 64.35 20.10 56 7991 59913 64430772
Nasopharyngitis 64.21 20.10 99 7948 195974 64294711
Diabetes mellitus inadequate control 63.14 20.10 37 8010 21284 64469401
Personality disorder 61.96 20.10 23 8024 4688 64485997
Adjustment disorder 61.71 20.10 20 8027 2725 64487960
Skin plaque 60.20 20.10 27 8020 8913 64481772
Malaise 53.59 20.10 138 7909 396109 64094576
Secretion discharge 52.71 20.10 27 8020 11937 64478748
Drug ineffective 50.27 20.10 222 7825 840025 63650660
Cystitis 50.16 20.10 42 8005 42633 64448052
Sensory loss 47.86 20.10 24 8023 10145 64480540
Affect lability 47.63 20.10 23 8024 8967 64481718
Pulmonary congestion 47.00 20.10 32 8015 23848 64466837
Panic attack 45.87 20.10 30 8017 20923 64469762
Infected dermal cyst 45.70 20.10 12 8035 780 64489905
Hemiplegia 42.72 20.10 24 8023 12744 64477941
Motor dysfunction 42.52 20.10 23 8024 11350 64479335
Blood pressure inadequately controlled 41.88 20.10 18 8029 5366 64485319
Multiple drug therapy 41.00 20.10 14 8033 2240 64488445
Influenza 40.87 20.10 58 7989 106473 64384212
Pulmonary mass 39.87 20.10 29 8018 23987 64466698
Coordination abnormal 39.19 20.10 24 8023 14940 64475745
Influenza like illness 38.75 20.10 43 8004 61659 64429026
Guttate psoriasis 37.79 20.10 9 8038 392 64490293
Eating disorder 36.63 20.10 24 8023 16781 64473904
Malignant melanoma stage I 35.55 20.10 7 8040 122 64490563
Movement disorder 35.24 20.10 26 8021 21974 64468711
Muscle spasticity 34.38 20.10 23 8024 16646 64474039
Erythrodermic psoriasis 33.45 20.10 11 8036 1568 64489117
Inappropriate schedule of product administration 32.12 20.10 48 7999 92238 64398447
Keratoacanthoma 30.36 20.10 9 8038 913 64489772
Exercise tolerance decreased 29.96 20.10 16 8031 7694 64482991
Headache 29.31 20.10 137 7910 529330 63961355
Gallbladder rupture 26.94 20.10 8 8039 816 64489869
Pain of skin 24.20 20.10 15 8032 9532 64481153
Hyperkeratosis 23.55 20.10 13 8034 6668 64484017
Thyroglossal cyst infection 22.65 20.10 4 8043 37 64490648
Hemiparesis 22.64 20.10 23 8024 29804 64460881
Serum procollagen type III N-terminal propeptide increased 21.70 20.10 4 8043 48 64490637
Skin fissures 20.72 20.10 14 8033 10292 64480393
Product dose omission issue 20.47 20.10 62 7985 194685 64296000
Burning sensation 20.46 20.10 28 8019 49636 64441049
Mastitis 20.18 20.10 8 8039 1946 64488739

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 (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
0.005% SORILUX MAYNE PHARMA N022563 Oct. 6, 2010 RX AEROSOL, FOAM TOPICAL May 6, 2022 NEW PATIENT POPULATION
0.064%;0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL July 25, 2022 NEW PATIENT POPULATION
0.064%;0.005% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL July 30, 2022 NEW PATIENT POPULATION
0.005% SORILUX MAYNE PHARMA N022563 Oct. 6, 2010 RX AEROSOL, FOAM TOPICAL Nov. 5, 2022 NEW PATIENT POPULATION
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
147657-22-5 SECONDARY_CAS_RN
143NQ3779B UNII
5288783 PUBCHEM_CID
136766 MMSL
368 MMSL
4322 MMSL
003941 NDDF
017139 NDDF
126232005 SNOMEDCT_US
395766004 SNOMEDCT_US
726717009 SNOMEDCT_US
4020856 VANDF

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 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
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 51407-606 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
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
Calcipotriene and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 63629-8617 OINTMENT 50 ug TOPICAL ANDA 24 sections
calcipotriene and betamethasone dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 63646-040 SUSPENSION 50 ug TOPICAL ANDA 25 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 66993-877 CREAM 50 ug TOPICAL NDA AUTHORIZED GENERIC 21 sections
calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 66993-878 OINTMENT 50 ug TOPICAL NDA AUTHORIZED GENERIC 21 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 68462-310 OINTMENT 50 ug TOPICAL ANDA 22 sections
calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 68462-501 CREAM 50 ug TOPICAL ANDA 20 sections