ESKATA (hydrogen peroxide)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-12-14
- Patent Cliff
- 2035
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION
ESKATA Approval History
What ESKATA Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03946202 | CCR5119 2019-001709-25 | Ph 2 | recruiting | KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer |
| NCT04659928 results posted | HSC-DB-20-1017 | Ph 4 | completed | Evaluation of Aerosol in a Dental Clinic |
| NCT02757651 | CCR4502 | Ph 1, Ph 2 | completed | KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response |
| NCT03536637 | DMT310-001 | Ph 2 | completed | DMT310-001 Topical in the Treatment of Acne Vulgaris |
| NCT03019224 | 104/2015 | Ph 4 | completed | Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening |
| NCT00978861 REMEWHITE | RE5 | Ph 3 | completed | Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE |
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.
ESKATA FDA Label Details
ESKATA Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for ESKATA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 5 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • 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