TheraRadar
Data updated: May 26, 2026

DUAC (benzoyl peroxide)

Dermatology Approved 2002-08-26

DUAC is indicated for the treatment of Acne.

Source: FDA Label • STIEFEL
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-08-26
Routes
TOPICAL
Dosage Forms
GEL

Companies

STIEFEL
Active Ingredient: BENZOYL PEROXIDE , CLINDAMYCIN PHOSPHATE

DUAC Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2002 to 2015
Apr 2015 SUPPL
Label · Labeling
FDA Letter Label
Oct 2014 SUPPL
Mfg · Manufacturing (CMC)
May 2014 SUPPL
Mfg · Manufacturing (CMC)

What DUAC Treats

1 indications

DUAC is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acne
Source: FDA Label

DUAC Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CABTREO
BAUSCH
2023 1 indic.
WINLEVI
Sun Pharma
2020 1 indic.
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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 DUAC

3 of 16

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ABSORICA
ISOTRETINOIN
1 shared
Sun Pharma
Shared indications:
Acne
AMNESTEEM
ISOTRETINOIN
1 shared
Viatris
Shared indications:
Acne
BEYAZ
DROSPIRENONE
1 shared
Bayer
Shared indications:
Acne
View all 16 similar drugs Pro
📋

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NCT05536882 IRB# 14663 Ph 3 withdrawn MC RCT - BPO vs Adapalene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

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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.

DUAC FDA Label Details

Indications & Usage

FDA Label (PDF)

DUAC is indicated for the treatment of Acne.

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Data Sources

FDA Approval: NDA050741 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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