ADAPALENE AND BENZOYL PEROXIDE (adapalene)
Adapalene and benzoyl peroxide is a topical gel used for acne vulgaris in adults and pediatric patients 12 years and older. This combination therapy helps patients manage their skin condition by combining a retinoid with an oxidizing agent. It is prescribed to address the various factors that contribute to acne breakouts.
How ADAPALENE AND BENZOYL PEROXIDE Works
This medication works by combining two active ingredients with different functions. Adapalene binds to specific retinoic acid nuclear receptors to modulate cellular differentiation and inflammatory processes, while benzoyl peroxide acts as an oxidizing agent with bactericidal and keratolytic effects.
Details
- Status
- Prescription
- First Approved
- 2015-09-30
- Routes
- TOPICAL
- Dosage Forms
- GEL
Companies
ADAPALENE AND BENZOYL PEROXIDE Approval History
What ADAPALENE AND BENZOYL PEROXIDE Treats
1 indicationsADAPALENE AND BENZOYL PEROXIDE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
ADAPALENE AND BENZOYL PEROXIDE 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.
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Clinical Trial Registry
5 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 |
| NCT00919191 results posted | CA-P-6805 | Ph 4 | completed | Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face |
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.
ADAPALENE AND BENZOYL PEROXIDE FDA Label Details
Indications & Usage
ADAPALENE AND BENZOYL PEROXIDE 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.