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.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Azelex, Finacea (generic drugs available since 2018-11-19)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 2% salicylic acid facial cleanser | OTC monograph final | 2023-04-11 |
| azelex | New Drug Application | 2019-10-02 |
| finacea | New Drug Application | 2023-02-06 |
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
36 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rosacea | D012393 | L71 | 3 | 3 | 8 | 5 | 3 | 21 | |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | 1 | 3 | 1 | 5 |
| Skin manifestations | D012877 | — | — | — | 2 | — | 2 | ||
| Melanosis | D008548 | EFO_0003963 | L81.1 | — | 1 | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erythema | D004890 | HP_0010783 | L53.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | 18602 |
| ChEMBL ID | CHEMBL1238 |
| ChEBI ID | 48131 |
| PubChem CID | 2266 |
| DrugBank | DB00548 |
| UNII ID | F2VW3D43YT (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,598 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
17,164 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more