EPSOLAY (benzoyl peroxide)
Epsolay is used for adults who have inflammatory lesions associated with rosacea. This medication helps patients with the specific skin bumps and blemishes that occur with this condition. It is prescribed to manage these inflammatory symptoms in the adult population.
How EPSOLAY Works
This medication works by acting as an oxidizing agent that provides both bactericidal and keratolytic effects on the skin. While the exact way it improves rosacea is not fully understood, these properties help address the underlying skin issues.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-04-22
- Patent Cliff
- 2041
- Routes
- TOPICAL
- Dosage Forms
- CREAM
EPSOLAY Approval History
What EPSOLAY Treats
1 indicationsEPSOLAY is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rosacea
EPSOLAY 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 EPSOLAY
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05536882 | IRB# 14663 | Ph 3 | withdrawn | MC RCT - BPO vs Adapalene |
| NCT04548349 results posted | 2020P000595 | Ph 4 | completed | Profiling the Skin Microbiome in Response to Altreno in Acne Patients |
| NCT02589405 Benzac results posted | RD.03.SPR.105041 | Ph 4 | completed | Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris |
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.
EPSOLAY FDA Label Details
Indications & Usage
EPSOLAY is indicated for the treatment of Rosacea.
EPSOLAY Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for EPSOLAY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 14 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment