TheraRadar
Data updated: Jun 28, 2026

DIFFERIN EPIDUO (adapalene) · GALDERMA LABS LP

Approved 2026-05-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Over-the-counter
First Approved
2026-05-22
Routes
TOPICAL
Dosage Forms
GEL

Companies

GALDERMA LABS LP
Active Ingredient: ADAPALENE , BENZOYL PEROXIDE

DIFFERIN EPIDUO Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
May 2026 ORIGINAL
Update · Type 8 - Partial Rx to OTC Switch
FDA Letter Label

What DIFFERIN EPIDUO Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)

GALDERMA LABS LP's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

NEMLUVIO
2024
NEMOLIZUMAB-ILTO
3 designations
AKLIEF
2019
TRIFAROTENE
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

DIFFERIN EPIDUO FDA Label Details

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Data Sources

FDA Approval: NDA220736 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.