NDATOPICALGEL
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
4/8 — Partial
FINACEA (azelaic acid) by Leo Pharma is mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown. First approved in 2002.
Drug data last refreshed 46m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FINACEA (azelaic acid) is a topical gel approved in 2002 for the treatment of rosacea, a chronic inflammatory skin condition. The exact mechanism by which azelaic acid interferes with pathogenic events in rosacea remains unknown, though clinical efficacy is established. It is administered as a non-systemic topical formulation.
LOE Approaching
As LOE approaches after 22 years on market, the brand team is likely downsizing with focus on generic transition planning and margin protection rather than growth initiatives.
Mechanism of Action
mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
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
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
Started Jul 2017
2,200 enrolled
Rosacea
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Started May 2014
22 enrolled
Acne Rosacea
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
Worked on FINACEA at Leo Pharma? Share your interview experience or compensation data (+7 days Pro)
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.