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

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

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 13, 1995 FDA ALLERGAN

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
Blepharospasm 147.01 30.88 30 1399 2918 50600777
Taste disorder 120.91 30.88 31 1398 8293 50595402
Epilepsy 87.83 30.88 30 1399 21537 50582158
Migraine 71.26 30.88 37 1392 75243 50528452
Gastrooesophageal reflux disease 59.49 30.88 33 1396 76395 50527300
Memory impairment 58.33 30.88 33 1396 79327 50524368
Paraesthesia 57.60 30.88 38 1391 120205 50483490
Abdominal pain upper 45.84 30.88 37 1392 159272 50444423
Product use in unapproved indication 40.01 30.88 30 1399 115789 50487906
Hypoaesthesia 39.66 30.88 31 1398 127226 50476469
Burning sensation 39.12 30.88 21 1408 45425 50558270
Transposition of the great vessels 36.80 30.88 6 1423 164 50603531
Product container issue 34.36 30.88 8 1421 1424 50602271
Application site pain 31.00 30.88 9 1420 3789 50599906

FDA Adverse Event Reporting System (Male)

None

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
Blepharospasm 143.55 36.53 28 1157 3347 64494200
Taste disorder 114.88 36.53 28 1157 9405 64488142
Epilepsy 79.80 36.53 28 1157 33503 64464044
Migraine 75.95 36.53 32 1153 62645 64434902
Paraesthesia 63.38 36.53 36 1149 134486 64363061
Memory impairment 63.33 36.53 31 1154 85651 64411896
Gastrooesophageal reflux disease 61.20 36.53 30 1155 83113 64414434
Abdominal pain upper 47.43 36.53 33 1152 174997 64322550
Hypoaesthesia 44.29 36.53 29 1156 139079 64358468
Pain 43.78 36.53 52 1133 553459 63944088

FDA Adverse Event Reporting System (Pediatric)

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
Transposition of the great vessels 30.02 24.07 5 10 26 84637

Pharmacologic Action:

SourceCodeDescription
ATC D10AX03 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Other anti-acne preparations for topical use
FDA PE N0000008841 Decreased Protein Synthesis
FDA PE N0000009982 Decreased Sebaceous Gland Activity
MeSH PA D000970 Antineoplastic Agents
MeSH PA D003879 Dermatologic Agents
CHEBI has role CHEBI:33282 bactericides
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50177 dermatologic agent
CHEBI has role CHEBI:76924 plant metabolites

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

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
15% FINACEA LEO PHARMA AS 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 LEO PHARMA AS N207071 July 29, 2015 RX AEROSOL, FOAM TOPICAL 10117812 Oct. 18, 2027 TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
15% FINACEA LEO PHARMA AS N207071 July 29, 2015 RX AEROSOL, FOAM TOPICAL 9211259 Feb. 28, 2029 TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4020935 VUID
N0000148416 NUI
D03034 KEGG_DRUG
18602 RXNORM
C0052761 UMLSCUI
CHEBI:48131 CHEBI
AZ1 PDB_CHEM_ID
CHEMBL1238 ChEMBL_ID
DB00548 DRUGBANK_ID
2266 PUBCHEM_CID
5883 INN_ID
C010038 MESH_SUPPLEMENTAL_RECORD_UI
7484 IUPHAR_LIGAND_ID
F2VW3D43YT UNII
4236 MMSL
46056 MMSL
72313 MMSL
003930 NDDF
4020935 VANDF
108908008 SNOMEDCT_US
386936005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Azelaic Acid HUMAN PRESCRIPTION DRUG LABEL 1 0115-1624 GEL 0.15 g TOPICAL ANDA 20 sections
azelaic acid HUMAN PRESCRIPTION DRUG LABEL 1 0591-2131 GEL 0.15 g TOPICAL ANDA 16 sections
azelaic acid HUMAN PRESCRIPTION DRUG LABEL 1 0591-2131 GEL 0.15 g TOPICAL ANDA 16 sections
Azelaic Acid Gel HUMAN PRESCRIPTION DRUG LABEL 1 0781-7172 GEL 0.15 g TOPICAL NDA AUTHORIZED GENERIC 26 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 10922-825 GEL 0.15 g TOPICAL NDA 21 sections
AZELEX HUMAN PRESCRIPTION DRUG LABEL 1 16110-869 CREAM 0.20 g CUTANEOUS NDA 20 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 50090-3032 GEL 0.15 g TOPICAL NDA 23 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 50090-4473 GEL 0.15 g TOPICAL NDA 26 sections
FINACEA FOAM HUMAN PRESCRIPTION DRUG LABEL 1 50222-303 AEROSOL, FOAM 0.15 g TOPICAL NDA 26 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 50222-505 GEL 0.15 g TOPICAL NDA 26 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 50419-825 GEL 0.15 g TOPICAL NDA 23 sections
FINACEA FOAM HUMAN PRESCRIPTION DRUG LABEL 1 50419-829 AEROSOL, FOAM 0.15 g TOPICAL NDA 23 sections
Azelaic Acid HUMAN PRESCRIPTION DRUG LABEL 1 51672-1389 GEL 0.15 g TOPICAL ANDA 26 sections
AZELEX HUMAN PRESCRIPTION DRUG LABEL 1 54868-4442 CREAM 0.20 g CUTANEOUS NDA 20 sections
Finacea HUMAN PRESCRIPTION DRUG LABEL 1 54868-5236 GEL 0.15 g TOPICAL NDA 13 sections
azelaic acid HUMAN PRESCRIPTION DRUG LABEL 1 68462-626 GEL 0.15 g TOPICAL ANDA 23 sections
AZELAIC ACID 15% / NIACINAMIDE 4% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2008 CREAM 15 g TOPICAL unapproved drug other 4 sections