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Drug

Azelaic acid

Regulatory activity · FDA
Emerging researchLate-stage development
Also known as Acide azélaïque, Acidum acelaicum, Acidum azelaicum, Anchoic acid+13 more

Acide azélaïque, Acidum acelaicum, Acidum azelaicum, Anchoic acid, Azelainsäure, Azelex, Finacea, Finevin, Lepargylic acid, NicAzel, Nonandisäure, Nonanedioic acid, n-nonanedioic acid, Ácido azelaico, 1,7-Heptanedicarboxylic acid, 1,7-dicarboxyheptane, 1,9-nonanedioic acid.

RxNorm18602ChEMBLCHEMBL1238ATCD10AX03UNIIF2VW3D43YT
1
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

Clinical trial2026-07-01Results expected Q4 2026 · ClinicalTrials.gov

Pilot Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

Clinical trial2026-01-27Results expected Q4 2026 · ClinicalTrials.gov

Recall (Class II): AZELAIC ACID

Regulatory2025-09-17FDA

Guidelines of care for the management of acne vulgaris.

Research2024-01-30Journal of the American Academy of Dermatology

A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.

Clinical trial2020-06-02Results posted · ClinicalTrials.gov

A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

Clinical trial2020-04-07Results posted · ClinicalTrials.gov

An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

Clinical trial2020-03-31Results posted · ClinicalTrials.gov

Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea

Clinical trial2018-09-12Results posted · ClinicalTrials.gov

The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea

Clinical trial2018-09-07Results posted · ClinicalTrials.gov

A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris

Clinical trial2017-08-25Results posted · ClinicalTrials.gov

The Influence of Peripheral Androgen Conversion at Toll-like Receptors-2 and CD1d Expressions in Human Keratinocytes as Well as Their Modulation After 6 Months Treatment With Oral Contraceptive.

Clinical trial2013-06-01Primary completion · ClinicalTrials.gov

Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

Clinical trial2012-09-25Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Azelaic acid
Aliases & brands
Acide azélaïqueAcidum acelaicumAcidum azelaicumAnchoic acidAzelainsäureAzelexFinaceaFinevinLepargylic acidNicAzelNonandisäureNonanedioic acidn-nonanedioic acidÁcido azelaico1,7-Heptanedicarboxylic acid1,7-dicarboxyheptane1,9-nonanedioic acid
RxNorm CUI
18602
ChEMBL ID
CHEMBL1238
ATC codes
D10AX03
UNII
F2VW3D43YT
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2025-09-17RecallSafety
Recall (Class II): AZELAIC ACID
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2014
2
Active studies
1
Recruiting
8
Late-stage (III+)
8
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 11
Early Phase 11Phase 11Phase 21Phase 2 / 31Phase 31Phase 44Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris

CompletedPH IVGlaxoSmithKlinen=2222014

Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea

CompletedPH IVDermatology Specialists Researchn=602011

Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

CompletedPH IVDerm Research, PLLCn=202010

An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

CompletedPH IVLEO Pharman=2072009

A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.

CompletedPH IIIKey trialActavis Inc.n=1,0092014

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris

CompletedPH IVGlaxoSmithKlinen=2222014

A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.

CompletedPH IIIKey trialActavis Inc.n=1,0092014

The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea

CompletedPH II/IIIWake Forest Universityn=202012

Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea

CompletedPH IVDermatology Specialists Researchn=602011

Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea

CompletedN/AWake Forest University Health Sciencesn=102011

Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

CompletedPH IVDerm Research, PLLCn=202010

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology · 2024 · 236 cites
Recent papers

Guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology · 2024 · 236 cites
Major research themes8
Acne Vulgaris1Anti-Bacterial Agents1Benzoyl Peroxide1Dermatologic Agents1Dicarboxylic Acids1Doxycycline1Isotretinoin1Salicylic Acid1
Journals, researchers & institutions
Top journals
  • Journal of the American Academy of Dermatology1
Leading researchers
  • Barbieri JS1
  • Cheng CE1
  • Cook-Bolden F1
  • Desai SR1
  • Druby KM1
  • Freeman EE1
  • Han JM1
  • Keri JE1
Leading institutions
free-text, unnormalised
  • American Academy of Dermatology1
  • Beth Israel Deaconess Medical Center1
  • Brigham and Women's Hospital1
  • Emory University School of Medicine1
  • Massachusetts General Hospital1
  • Mayo Clinic1

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Benzoyl Peroxide

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Clascoterone

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Doxycycline

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Isotretinoin

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Minocycline

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Salicylic Acid

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Sarecycline

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
Spironolactone

Studied across the same disease area as Azelaic acid in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.