Azelaic Acid

Summary

Azelaic Acid (CHEMBL1238) is an approved small-molecule antibacterial agent (ATC D10AX03); indicated across 6 conditions including rosacea and acne.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: D10AX03
• Indications: 6 conditions
• Clinical trials: 20
• Chemistry: 188.22 Da · C9H16O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1238
Name	Azelaic Acid
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	2266
ChEBI	CHEBI:48131
ATC	D10AX03
Molecular formula	C9H16O4
Molecular weight	188.22
InChIKey	BDJRBEYXGGNYIS-UHFFFAOYSA-N

SMILES: C(CCCC(=O)O)CCCC(=O)O

IUPAC name: nonanedioic acid

ChEBI definition: An α,ω-dicarboxylic acid that is heptane substituted at positions 1 and 7 by carboxy groups.

Pharmacological roles (ChEBI): antibacterial agent, antineoplastic agent, dermatologic drug.

Other ChEBI roles (chemical / environmental): plant metabolite.

Also known as: Acide azelaique, Acido azelaico, Anchoic acid, Azelaic acid, Azelate, Azelex, Finacea, Lepargylic acid, NSC-19493, Skinoren, ZK 62498, ZK-62498

Patent coverage: 54,363 distinct patent families (152,287 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 6 (assay-derived). Sample: Prelamin-A/C, 4’-phosphopantetheinyl transferase ffp, Ferritin light chain, Peripheral myelin protein 22, Thyrotropin receptor, Nuclear factor NF-kappa-B p105 subunit.

Bioactivity

ChEMBL activities: 8 potent at pChembl ≥ 5 of 9 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
NFKB1	8.55	Potency	2.8	nM	CHEMBL_ACT_3675718
NFKB1	8.55	Potency	2.8	nM	CHEMBL_ACT_4588900
LMNA	8.3	Potency	5	nM	CHEMBL_ACT_3652019
LMNA	7	Potency	100	nM	CHEMBL_ACT_3662458
P02791	6.5	Potency	316.2	nM	CHEMBL_ACT_4496244
Q9F4F7	5.5	Potency	3162	nM	CHEMBL_ACT_4378408
TSHR	5.2	Potency	6310	nM	CHEMBL_ACT_3924769
TSHR	5.2	Potency	6310	nM	CHEMBL_ACT_4619556

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
rosacea	4	MONDO:0006604	EFO:1000760
acne	4	MONDO:0011438	EFO:0003894
seborrheic dermatitis	2	MONDO:0006608	EFO:1000764

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 20.

Phase distribution

Phase	Trials
PHASE4	8
PHASE3	3
PHASE2	3
PHASE1	2
Not specified	2
PHASE2/PHASE3	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00417937	PHASE4	COMPLETED	A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
NCT01038869	PHASE4	COMPLETED	Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)
NCT01139008	PHASE4	COMPLETED	Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
NCT01139047	PHASE4	COMPLETED	Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
NCT01387048	PHASE4	COMPLETED	Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin
NCT02058628	PHASE4	COMPLETED	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris
NCT02147691	PHASE4	COMPLETED	Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
NCT05014906	PHASE4	COMPLETED	Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea
NCT01493687	PHASE3	COMPLETED	Phase 3 Papulopustular Rosacea Study
NCT01494467	PHASE3	COMPLETED	Phase 3 Papulopustular Rosacea Study
NCT02120924	PHASE3	COMPLETED	A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
NCT03035955	PHASE2/PHASE3	COMPLETED	Azelaic Acid on Demodex Counts in Rosacea
NCT00403949	PHASE2	COMPLETED	A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
NCT00408330	PHASE2	COMPLETED	A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face
NCT00617903	PHASE2	COMPLETED	Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
NCT06966388	PHASE1	RECRUITING	Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
NCT03094403	PHASE1	COMPLETED	To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
NCT05416333	EARLY_PHASE1	ACTIVE_NOT_RECRUITING	Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
NCT01631656	Not specified	COMPLETED	Combination Gel and Vascular ND in Mild to Moderate Rosacea
NCT07327983	Not specified	COMPLETED	Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).