azelaic acid indications/contra

Stem definitionDrug idCAS RN
270 123-99-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nonanedioic acid
  • azelaic acid dipotassium salt
  • azelaic acid
  • anchoic acid
  • finacea
  • lepargylic acid
  • n-Nonanedioic acid
  • Molecular weight: 188.22
  • Formula: C9H16O4
  • CLOGP: 1.56
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 74.60
  • ALOGS: -1.92
  • ROTB: 8

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 13, 1995 FDA ALLERGAN

FDA Adverse Event Reporting System

None

Pharmacologic Action:

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SourceCodeDescription
ATC D10AX03 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Other anti-acne preparations for topical use
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50177 dermatologic drug
FDA PE N0000008841 Decreased Protein Synthesis
FDA PE N0000009982 Decreased Sebaceous Gland Activity
MeSH PA D000970 Antineoplastic Agents
MeSH PA D003879 Dermatologic Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Acne vulgaris indication 88616000
Rosacea indication 398909004 DOID:8881
Skin hypopigmented contraindication 23006000
Wilson's disease contraindication 88518009 DOID:893
Skin irritation contraindication 367466007

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.46 acidic
pKa2 5.06 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
15% FINACEA BAYER HLTHCARE N207071 July 29, 2015 RX AEROSOL, FOAM TOPICAL 8435498 March 1, 2024 TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
15% FINACEA BAYER HLTHCARE N207071 July 29, 2015 RX AEROSOL, FOAM TOPICAL 9211259 Jan. 26, 2029 TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
15% FINACEA BAYER HLTHCARE N207071 July 29, 2015 RX AEROSOL, FOAM TOPICAL July 29, 2018 NEW PRODUCT

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2 Enzyme WOMBAT-PK

External reference:

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IDSource
CHEBI:48131 CHEBI
DB00548 DRUGBANK_ID
4020935 VUID
N0000148416 NUI
C0052761 UMLSCUI
7484 IUPHAR_LIGAND_ID
D03034 KEGG_DRUG
2266 PUBCHEM_CID
4020935 VANDF
72313 MMSL
N0000148416 NDFRT
N0000006287 NDFRT
003930 NDDF
4236 MMSL
18602 RXNORM
108908008 SNOMEDCT_US
386936005 SNOMEDCT_US
CHEMBL1238 ChEMBL_ID
F2VW3D43YT UNII
5883 INN_ID
C010038 MESH_SUPPLEMENTAL_RECORD_UI
AZ1 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
AZELEX HUMAN PRESCRIPTION DRUG LABEL 1 0023-8694 CREAM 0.20 g CUTANEOUS NDA 11 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 10922-825 GEL 0.15 g TOPICAL NDA 12 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 10922-826 KIT 0.15 g None NDA 12 sections
Azelaic Acid HUMAN PRESCRIPTION DRUG LABEL 1 47781-447 GEL 0.15 g TOPICAL NDA authorized generic 15 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 50419-825 GEL 0.15 g TOPICAL NDA 16 sections
FINACEA FOAM HUMAN PRESCRIPTION DRUG LABEL 1 50419-829 AEROSOL, FOAM 0.15 g TOPICAL NDA 14 sections
AZELEX HUMAN PRESCRIPTION DRUG LABEL 1 54868-4442 CREAM 0.20 g CUTANEOUS NDA 11 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 54868-5236 GEL 0.15 g TOPICAL NDA 13 sections