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

Stem definition	Drug id	CAS RN
	270	123-99-9

Description:

Molecule

Description

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:

Date	Agency	Company	Orphan
Sept. 13, 1995	FDA	ALLERGAN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Transposition of the great vessels	30.02	24.07	5	10	26	84637

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	4.46	acidic
pKa2	5.06	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme	P31213	S5A2_HUMAN					WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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