calcipotriene indications/contra

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

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA

FDA Adverse Event Reporting System

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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 73.26 48.59 19 157 20329 3365354
Guttate psoriasis 52.64 48.59 7 169 177 3385506
Hypercalcaemia 48.77 48.59 10 166 3727 3381956

Pharmacologic Action:

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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 Chemical/Ingredient N0000006277 Vitamin D
FDA EPC N0000175849 Vitamin D Analog
MeSH PA D003879 Dermatologic Agents
CHEBI has role CHEBI:50748 antipsoriatic

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
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 DOID:8503
Telangiectasia disorder contraindication 247479008 DOID:1272
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006 DOID:2733
Peripheral vascular disease contraindication 400047006
Psoriasis off-label use 9014002 DOID:8893

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.7 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.005% TACLONEX LEO PHARMA AS N021852 Jan. 9, 2006 RX OINTMENT TOPICAL 6753013 Jan. 27, 2020 PSORIASIS
0.005% TACLONEX LEO PHARMA AS N021852 Jan. 9, 2006 RX OINTMENT TOPICAL 6753013 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 PLAQUE PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 PLAQUE PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 PSORIASIS
0.005% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.005% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL 6753013 Jan. 27, 2020 PLAQUE PSORIASIS
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 8263580 Sept. 27, 2028 USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
0.005% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL 9119781 June 10, 2031 PLAQUE PSORIASIS

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.005% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL Oct. 16, 2018 NEW PRODUCT

Bioactivity Summary:

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

External reference:

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IDSource
4020856 VUID
N0000148363 NUI
C0065767 UMLSCUI
D01125 KEGG_DRUG
143NQ3779B UNII
6376 INN_ID
4020856 VANDF
136766 MMSL
N0000006397 NDFRT
N0000148363 NDFRT
4322 MMSL
29365 RXNORM
395766004 SNOMEDCT_US
003941 NDDF
126232005 SNOMEDCT_US
5288783 PUBCHEM_CID
CHEMBL1200666 ChEMBL_ID
CHEMBL1234231 ChEMBL_ID
DB02300 DRUGBANK_ID
147657-22-5 SECONDARY_CAS_RN
C055085 MESH_SUPPLEMENTAL_RECORD_UI
CHEBI:90861 CHEBI
MC9 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 0115-1475 SOLUTION 0.05 mg TOPICAL ANDA 12 sections
SORILUX HUMAN PRESCRIPTION DRUG LABEL 1 0145-2130 AEROSOL, FOAM 50 ug TOPICAL NDA 17 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 0168-0400 SOLUTION 0.05 mg TOPICAL ANDA 13 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0318 SOLUTION 0.05 mg TOPICAL ANDA 13 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 0781-7117 CREAM 0.05 mg TOPICAL ANDA 12 sections
CALCIPOTRIENE 0.005% AND BETAMETHASONE DIPROPIONATE 0.064% HUMAN PRESCRIPTION DRUG LABEL 2 0781-7165 OINTMENT 50 ug TOPICAL ANDA 16 sections
Calcipotriene and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 45802-989 OINTMENT 50 ug TOPICAL NDA authorized generic 16 sections
Taclonex HUMAN PRESCRIPTION DRUG LABEL 2 50222-227 OINTMENT 50 ug TOPICAL NDA 16 sections
Dovonex HUMAN PRESCRIPTION DRUG LABEL 1 50222-260 CREAM 50 ug TOPICAL NDA 14 sections
ENSTILAR HUMAN PRESCRIPTION DRUG LABEL 2 50222-302 AEROSOL, FOAM 50 ug TOPICAL NDA 16 sections
TACLONEX HUMAN PRESCRIPTION DRUG LABEL 2 50222-501 SUSPENSION 50 ug TOPICAL NDA 16 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 50383-732 SOLUTION 0.05 mg TOPICAL ANDA 14 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 51672-4154 OINTMENT 0.05 mg TOPICAL ANDA 13 sections
Calcitrene HUMAN PRESCRIPTION DRUG LABEL 1 51672-5278 OINTMENT 0.05 mg TOPICAL ANDA 12 sections
SORILUX HUMAN PRESCRIPTION DRUG LABEL 1 51862-376 AEROSOL, FOAM 50 ug TOPICAL NDA 18 sections
Dovonex HUMAN PRESCRIPTION DRUG LABEL 1 54868-4725 CREAM 50 ug TOPICAL NDA 13 sections
Taclonex HUMAN PRESCRIPTION DRUG LABEL 2 54868-5680 OINTMENT 50 ug TOPICAL NDA 17 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 16 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 66993-877 CREAM 50 ug TOPICAL NDA authorized generic 14 sections
calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 66993-878 OINTMENT 50 ug TOPICAL NDA authorized generic 14 sections
Calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 68462-310 OINTMENT 50 ug TOPICAL ANDA 14 sections
calcipotriene HUMAN PRESCRIPTION DRUG LABEL 1 68462-501 CREAM 50 ug TOPICAL ANDA 13 sections