FINACEA (azelaic acid)
Finacea is a topical gel used for patients who have mild to moderate rosacea. It specifically helps patients with the inflammatory papules and pustules associated with this skin condition. While it may help reduce some redness in these patients, it is primarily prescribed to manage the bumps and pimples rather than redness alone.
How FINACEA Works
The exact way that azelaic acid works to address the underlying causes of rosacea is not currently known. It is used to interfere with the disease process, though the specific biological targets remain unidentified.
Details
- Status
- Prescription
- First Approved
- 2002-12-24
- Patent Cliff
- 2029
- Routes
- TOPICAL
- Dosage Forms
- AEROSOL, FOAM, GEL
FINACEA Approval History
What FINACEA Treats
1 indicationsFINACEA is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rosacea
FINACEA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FINACEA
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06966388 | MCC-23-20546 | Ph 1 | recruiting | Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation |
| NCT05014906 | ROS001 | Ph 4 | completed | Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea |
| NCT02120924 results posted | 13-1014 | Ph 3 | completed | A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea |
| NCT00617903 results posted | 1402140 | Ph 2 | completed | Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea |
| NCT03035955 results posted | IRB00014511 | Ph 2, Ph 3 | completed | Azelaic Acid on Demodex Counts in Rosacea |
| NCT02058628 results posted | 200398 | Ph 4 | completed | Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris |
| NCT01038869 results posted | FIN0901 | Ph 4 | completed | Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FINACEA FDA Label Details
Indications & Usage
FDA Label (PDF)FINACEA is indicated for the treatment of Rosacea.
FINACEA Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for FINACEA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.