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

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	327.57	33.15	68	2115	5928	63480911
Taste disorder	281.87	33.15	70	2113	13592	63473247
Epilepsy	225.79	33.15	68	2115	26997	63459842
Migraine	152.32	33.15	73	2110	103273	63383566
Gastrooesophageal reflux disease	151.48	33.15	71	2112	95568	63391271
Memory impairment	145.64	33.15	71	2112	104187	63382652
Paraesthesia	131.56	33.15	76	2107	156890	63329949
Hypoaesthesia	111.21	33.15	70	2113	168323	63318516
Abdominal pain upper	109.99	33.15	75	2108	206369	63280470
Drug intolerance	67.81	33.15	67	2116	308594	63178245
Product use in unapproved indication	57.13	33.15	48	2135	179032	63307807
Pain	56.67	33.15	95	2088	740533	62746306
Vomiting	54.10	33.15	80	2103	559537	62927302
Burning sensation	34.19	33.15	22	2161	54385	63432454
Transposition of the great vessels	33.53	33.15	6	2177	235	63486604

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	240.40	36.66	48	1588	5803	79736949
Taste disorder	197.89	36.66	49	1587	15774	79726978
Epilepsy	147.81	36.66	48	1588	40812	79701940
Migraine	122.23	36.66	51	1585	87442	79655310
Gastrooesophageal reflux disease	110.44	36.66	50	1586	104196	79638556
Memory impairment	110.24	36.66	51	1585	111683	79631069
Paraesthesia	101.89	36.66	56	1580	176267	79566485
Hypoaesthesia	84.81	36.66	50	1586	179302	79563450
Abdominal pain upper	81.96	36.66	53	1583	223766	79518986
Pain	60.81	36.66	73	1563	703729	79039023
Drug intolerance	60.49	36.66	47	1589	264072	79478680
Product use in unapproved indication	56.11	36.66	44	1592	250315	79492437
Vomiting	38.67	36.66	57	1579	665771	79076981

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	30.31	23.37	5	10	26	89751

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
108908008	SNOMEDCT_US
386936005	SNOMEDCT_US
4020935	VANDF
003930	NDDF

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	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
AnubisMed	HUMAN OTC DRUG LABEL	7	83021-402	LIQUID	7 g	TOPICAL	OTC monograph final	9 sections
2% Salicylic Acid FACIAL CLEANSER	HUMAN OTC DRUG LABEL	5	83325-003	LIQUID	10 mg	TOPICAL	OTC monograph final	10 sections