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Drug ReportsAzelaic acid
Azelaic acid
Azelaic Acid, Azelex, Finacea (azelaic acid) is a small molecule pharmaceutical. Azelaic acid was first approved as Azelex on 1995-09-13. It is used to treat acne vulgaris and rosacea in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Azelaic acid, Azelex, Finacea (discontinued: Azelaic acid)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azelaic acid
Tradename
Company
Number
Date
Products
AZELEXAlmirallN-020428 RX1995-09-13
1 products, RLD, RS
FINACEALEO PharmaN-021470 RX2002-12-24
1 products, RLD, RS
FINACEALEO PharmaN-207071 RX2015-07-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
10% azelaic acid acne creamunapproved drug other2024-09-29
15% azelaic acid acne creamunapproved drug other2024-09-29
anubismedOTC monograph final2023-09-05
azelaic acidANDA2025-08-22
azelaic acid 15% / niacinamide 4%unapproved drug other2019-04-23
azelaic acid 20% creamC2002632024-12-11
azelaic acid gelANDA2025-09-04
azelexNew Drug Application2024-03-04
biboya azelaic acid tea tree acne creamC2002632024-08-15
finaceaNew Drug Application2025-01-06
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
rosacea—D012393L71
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Azelaic Acid, Finacea, Leo Pharma As
92112592029-02-28U-1796
92657252027-12-08DP
101178122027-10-18DPU-1796
77000762027-09-18DP
84354982024-03-01U-1727
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AX: Other anti-acne preparations for topical use in atc
— D10AX03: Azelaic acid
HCPCS
No data
Clinical
Clinical Trials
44 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RosaceaD012393—L712————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAzelaic acid
INNazelaic acid
Description
Nonanedioic acid is an alpha,omega-dicarboxylic acid that is heptane substituted at positions 1 and 7 by carboxy groups. It has a role as an antibacterial agent, an antineoplastic agent, a dermatologic drug and a plant metabolite. It is a dicarboxylic fatty acid and an alpha,omega-dicarboxylic acid. It is a conjugate acid of an azelaate(2-) and an azelaate.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCCCCCCC(=O)O
Identifiers
PDB—
CAS-ID123-99-9
RxCUI—
ChEMBL IDCHEMBL1238
ChEBI ID48131
PubChem CID2266
DrugBankDB00548
UNII IDF2VW3D43YT (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Azelaic acid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,329 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,760 adverse events reported
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