NDATOPICALCREAM
Approved
Sep 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZELEX is a topical cream containing azelaic acid approved in 1995 for treating rosacea, acne vulgaris, seborrheic dermatitis, perioral dermatitis, and post-inflammatory hyperpigmentation. The exact mechanism of action in rosacea remains unknown, though the drug has demonstrated clinical efficacy across multiple inflammatory skin conditions. It represents a non-biologic, small-molecule dermatological treatment with a decades-long market presence.
$2MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Part D engagement ($2M annual spend), indicating a shrinking brand team and focus shifting toward generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Started Nov 2022
50 enrolled
Melasma
Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea
Started Dec 2017
5 enrolled
Rosacea, Papulopustular
Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris
Started Feb 2014
222 enrolled
Acne Vulgaris
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Started Sep 2012
70 enrolled
ErythemaRosacea
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Started Sep 2012
961 enrolled
Papulopustular Rosacea
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.