EPIDUO FORTE (adapalene)
Epiduo Forte is a topical medication used for acne vulgaris in adults and children 12 years of age and older. This combination therapy helps patients manage their skin by pairing a retinoid with an oxidizing agent. It is prescribed to address the various biological processes that contribute to acne breakouts.
How EPIDUO FORTE Works
This medication works by utilizing two active components with different effects. Adapalene binds to specific retinoic acid nuclear receptors to modulate cellular differentiation, keratinization, and inflammatory processes, while benzoyl peroxide acts as an oxidizing agent that provides bactericidal and keratolytic effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-07-15
- Routes
- TOPICAL
- Dosage Forms
- GEL
EPIDUO FORTE Approval History
What EPIDUO FORTE Treats
1 indicationsEPIDUO FORTE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
EPIDUO FORTE 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 EPIDUO FORTE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01213199 results posted | RD.03.SPR.29088 | Ph 2 | completed | Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars |
| NCT00660985 results posted | RD.06.SPR.18115 | Ph 4 | completed | Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1% |
| NCT03626298 | PapulexPaper1 | Ph 4 | completed | Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia |
| NCT01406080 FOTEN | BR.10.002 | Ph 3 | completed | A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging |
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.
EPIDUO FORTE FDA Label Details
Indications & Usage
FDA Label (PDF)EPIDUO FORTE is indicated for the treatment of Acne Vulgaris.
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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