Benzoyl peroxide

Overview

Benzoyl peroxide is a commonly used drug in topical treatments for acne. It has been formulated as products with either a single active ingredient, or with erythromycin, clindamycin, or adapalene. After administration, the peroxide bond is cleaved, allowing benzoyloxy radicals to nonspecifically interact with proteins. This treatment decreases keratin and sebum around follicles, as well as increasing turnover of epithelial cells. Benzoyl peroxide, in combination with erythromycin, was granted FDA approval on 26 October 1984.

Indication

Benzoyl peroxide is formulated with antibiotics such as erythromycin and clindamycin for the treatment of acne vulgaris. Benzoyl peroxide is formulated as a number of topical products for the treatment of acne. Benzoyl peroxide is also indicated in combination with tretinoin for the treatment of acne vulgaris in patients aged nine years and older. A triple-combination therapy including both clindamycin and adapalene is also available and indicated for the treatment of acne vulgaris in patients ≥12 years of age. Topical benzoyl peroxide is also indicated for the treatment of inflammatory lesions of rosacea in adults.

Associated Conditions

Acne
Acne Vulgaris
Inflammatory Acne Vulgaris
Inflammatory lesions caused by rosacea

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris.	2024/11/05	NCT06673641	Phase 1	Completed	Taro Pharmaceuticals USA
MC RCT - BPO vs Adapalene	2022/09/13	NCT05536882	Phase 3	Withdrawn	University of Oklahoma
Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery	2022/05/02	NCT05355844	Not Applicable	UNKNOWN	Hospital del Mar
Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel	2021/05/19	NCT04892706	Phase 2	Completed	Bausch Health Americas, Inc.
Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients	2020/09/29	NCT04569422	N/A	UNKNOWN	Aier School of Ophthalmology, Central South University
Profiling the Skin Microbiome in Response to Altreno in Acne Patients	2020/09/14	NCT04548349	Phase 4	Completed	Beth Israel Deaconess Medical Center
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea	2018/06/20	NCT03564119	Phase 3	Completed	Sol-Gel Technologies, Ltd.
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea	2018/06/20	NCT03564145	Phase 3	Terminated	Sol-Gel Technologies, Ltd.
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea	2018/02/28	NCT03448939	Phase 3	Completed	Sol-Gel Technologies, Ltd.
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color	2018/01/18	NCT03402893	Phase 4	Completed	Derm Research, PLLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / TRETINOIN 0.05%	Sincerus Florida, LLC	72934-1017	TOPICAL	5 g in 100 g	4/23/2019
clindamycin and benzoyl peroxide	NorthStar RxLLC	16714-984	TOPICAL	50 mg in 1 g	6/28/2019
BenzePrO	PruGen, Inc.	42546-016	TOPICAL	60 mg in 1 1	1/19/2022
EPIDUO	Galderma Laboratories, L.P.	0299-5908	TOPICAL	25 mg in 1 g	2/19/2018
BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / TRETINOIN 0.025%	Sincerus Florida, LLC	72934-1022	TOPICAL	2.5 g in 100 g	5/22/2019
Adapalene and benzoyl peroxide	Zydus Lifesciences Limited	70771-1716	TOPICAL	25 mg in 1 g	6/6/2022
Clindamycin Phosphate and Benzoyl Peroxide	Oceanside Pharmaceuticals	68682-132	TOPICAL	25 mg in 1 g	9/30/2020
Erythromycin and Benzoyl Peroxide	Rising Pharmaceuticals, Inc.	64980-328	TOPICAL	50 mg in 1 g	11/7/2022
Clindamycin Phosphate and Benzoyl Peroxide	Oceanside Pharmaceuticals	68682-133	TOPICAL	37.5 mg in 1 g	1/1/2023
epiduo forte	Galderma Laboratories, L.P.	0299-5906	TOPICAL	25 mg in 1 g	4/27/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
EPIDUO GEL 0.1%/2.5%	LABORATOIRES GALDERMA	SIN13789P	GEL	2.50%	4/21/2010
CLINDOXYL Once Daily Gel	Stiefel Laboratories (Ireland) Ltd, Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)	SIN13332P	GEL	6.67% w/w	8/7/2007
EPIDUO FORTE GEL 0.3%/2.5%	G PRODUCTION INC, Laboratoires Galderma	SIN15460P	GEL	2.50 %W/W	4/3/2018

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
DUAC ONCE DAILY GEL (UNITED KINGDOM)	N/A	葛兰素史克	N/A	N/A	9/25/2013

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EPIDUO adapalene / benzoyl peroxide 0.1%/2.5% gel tube	143869	Galderma Australia Pty Ltd	Medicine	A	1/22/2009
BENZAC AC 2 1/2% benzoyl peroxide 25mg/g gel tube	25270	Galderma Australia Pty Ltd	Medicine	A	10/15/1991
EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel bottle	273168	Galderma Australia Pty Ltd	Medicine	A	3/10/2017
BENZAC AC 10% benzoyl peroxide 100mg/g gel tube	25268	Galderma Australia Pty Ltd	Medicine	A	10/15/1991
EPIDUO 0.1%/2.5% adapalene / benzoyl peroxide gel bottle	222977	Galderma Australia Pty Ltd	Medicine	A	8/7/2014
ADAPAX 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle	427930	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/31/2025
CLEARASIL ULTRA ACNE TREATMENT CREAM tube (reformulation)	60739	Reckitt Benckiser Pty Ltd	Medicine	A	8/14/1997
DUAC ONCE DAILY GEL clindamycin (as phosphate ) 1% and benzoyl peroxide 5% topical gel tube	100707	GlaxoSmithKline Australia Pty Ltd	Medicine	A	1/30/2006
NOVADUO 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle	427929	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/31/2025
OXY 5 CAMOUFLAGE CREAM benzoyl peroxide 50 mg/g cream tube	10339	Neo Health (OTC) Pty Ltd	Medicine	A	7/4/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
5 BENZAGEL LIQUID ACNE SOAP 5%	rhone-poulenc rorer consumer inc.	02034638	Liquid - Topical	5 %	12/31/1993
PROACTIV+ PORE TARGETING SOLUTION	Alchemee LLC	02411245	Gel - Topical	2.5 % / W/W	6/20/2014
2.5 BENZAGEL ACNE LOTION 2.5%	rhone-poulenc rorer consumer inc.	02016427	Lotion - Topical	2.5 %	12/31/1993
ACNE THERAPY CLEANSING WASH	valeant canada lp / valeant canada s.e.c.	02322749	Solution - Topical	5.0 % / W/W	6/18/2010
CLEAN AND CLEAR ADVANTAGE ACNE TARGETING TREATMENT	johnson & johnson inc	02433273	Gel - Topical	2.5 % / W/W	N/A
CLEAR ACTION BENZOYL PEROXIDE ACNE TREATMENT 5%	crls	02517515	Gel - Topical	5 % / W/W	6/22/2024
CLEAR SKIN TREATMENT REPAIRING LOTION	valeant canada lp / valeant canada s.e.c.	02266679	Liquid - Topical	3.7 %	10/9/2005
CLENZIDERM NORMAL TO DRY SKIN/ PEAU NORMALE À SÈCHE	valeant groupe cosmederme inc	02440490	Kit , Lotion - Topical	5 % / W/W	N/A
ACNE FOAMING CLEANSER	cerave canada	02508745	Gel - Topical	4 % / W/W	2/1/2022
ACNE FOAMING CLEANSER	crls	02533715	Gel - Topical	4 % / W/W	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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