NDATOPICALCREAM
Approved
Sep 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZELEX (azelaic acid) is a topical cream indicated for rosacea and other dermatological conditions. Azelaic acid works through antimicrobial and anti-inflammatory mechanisms to reduce facial erythema and papules. The product targets patients with mild-to-moderate acne and rosacea seeking non-systemic treatment options.
$2.0MPart D
LOE ApproachingDeclining
With LOE approaching and modest Part D spending ($2M), this product is in lifecycle contraction; brand team focus shifts to generic transition planning and retention strategies for remaining market share.
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
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Started Sep 2012
961 enrolled
Papulopustular Rosacea
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
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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.