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 diseases | D017437 |
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 |
|---|---|---|---|---|
| AZELEX | Almirall | N-020428 RX | 1995-09-13 | 1 products, RLD, RS |
| FINACEA | LEO Pharma | N-021470 RX | 2002-12-24 | 1 products, RLD, RS |
| FINACEA | LEO Pharma | N-207071 RX | 2015-07-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 10% azelaic acid acne cream | unapproved drug other | 2024-09-29 |
| 15% azelaic acid acne cream | unapproved drug other | 2024-09-29 |
| anubismed | OTC monograph final | 2023-09-05 |
| azelaic acid | ANDA | 2025-08-22 |
| azelaic acid 15% / niacinamide 4% | unapproved drug other | 2019-04-23 |
| azelaic acid 20% cream | C200263 | 2024-12-11 |
| azelaic acid gel | ANDA | 2025-09-04 |
| azelex | New Drug Application | 2024-03-04 |
| biboya azelaic acid tea tree acne cream | C200263 | 2024-08-15 |
| finacea | New Drug Application | 2025-01-06 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acne vulgaris | EFO_0003894 | D000152 | L70 |
| rosacea | — | D012393 | L71 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
44 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rosacea | D012393 | — | L71 | 3 | 3 | 8 | 6 | 3 | 22 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 1 | 3 | 1 | 4 | 1 | 9 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 1 | 1 | 1 | 1 | 1 | 4 |
| Skin manifestations | D012877 | — | — | — | — | — | 2 | — | 2 |
| Hyperpigmentation | D017495 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | — | L30.9 | — | 2 | — | — | — | 2 |
| Seborrheic dermatitis | D012628 | — | L21 | — | 1 | — | — | — | 1 |
| Perioral dermatitis | D019557 | EFO_1001305 | L71.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | — | — | — | 1 |
| Alopecia | D000505 | — | L64 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin abnormalities | D012868 | — | Q82.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azelaic acid |
| INN | azelaic 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCCCCCC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 123-99-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1238 |
| ChEBI ID | 48131 |
| PubChem CID | 2266 |
| DrugBank | DB00548 |
| UNII ID | F2VW3D43YT (ChemIDplus, GSRS) |
Target
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Variants
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Estimated US medical usage
Azelaic acid
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,367 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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1,760 adverse events reported
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