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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/01/08 | Phase 3 | Completed | |||
2017/08/22 | Phase 2 | Completed | |||
2016/04/07 | Phase 4 | Completed | |||
2016/03/16 | Phase 1 | Completed | |||
2016/01/08 | Phase 3 | Completed | |||
2015/11/30 | Phase 3 | Completed | |||
2015/11/03 | Phase 1 | Completed | |||
2015/10/28 | Phase 4 | Completed | |||
2015/09/23 | Phase 4 | Completed | |||
2015/06/08 | Phase 3 | Completed | Glenmark Pharmaceuticals Ltd. India |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PruGen, Inc. | 42546-017 | TOPICAL | 7 g in 100 g | 7/5/2018 | |
| Sincerus Florida, LLC | 72934-1002 | TOPICAL | 2.5 g in 100 g | 6/3/2020 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1384 | TOPICAL | 25 mg in 1 g | 12/27/2022 | |
| Actavis Pharma, Inc. | 0591-3916 | TOPICAL | 25 mg in 1 g | 5/31/2020 | |
| Sincerus Florida, LLC | 72934-1018 | TOPICAL | 5 g in 100 g | 6/4/2020 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-301 | TOPICAL | 25 mg in 1 g | 11/30/2020 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-597 | TOPICAL | 25 mg in 1 g | 9/12/2019 | |
| Medimetriks Pharmaceuticals | 43538-176 | TOPICAL | 50 mg in 1 g | 1/1/2023 | |
| Bryant Ranch Prepack | 72162-2077 | TOPICAL | 25 mg in 1 g | 9/12/2019 | |
| Physicians Total Care, Inc. | 54868-5617 | TOPICAL | 50 mg in 1 g | 10/20/2010 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Benzoyl Peroxide Gel | 国药准字H20063377 | 化学药品 | 凝胶剂 | 5/5/2022 | |
| Benzoyl Peroxide Gel | 国药准字H22023827 | 化学药品 | 凝胶剂 | 6/12/2020 | |
| Benzoyl Peroxide Gel | 国药准字H10983203 | 化学药品 | 凝胶剂 | 5/17/2021 | |
| Benzoyl Peroxide Gel | 国药准字H35021145 | 化学药品 | 凝胶剂 | 7/19/2022 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel tube | 273181 | Medicine | A | 3/10/2017 | |
| OXY 5 VANISHING CREAM benzoyl peroxide 50 mg/g cream tube | 10340 | Medicine | A | 7/4/1991 | |
| OXY 10 VANISHING CREAM benzoyl peroxide 100mg/g cream tube | 10337 | Medicine | A | 7/4/1991 | |
| BENZAC AC WASH 5% benzoyl peroxide 50mg/g application bottle | 52350 | Medicine | A | 5/11/1995 | |
| NOVADAC ONCE DAILY GEL clindamycin (as phosphate) 1% w/w / benzoyl peroxide 5% w/w topical gel tube | 406130 | Medicine | A | 5/29/2024 | |
| BENZAC AC 5% benzoyl peroxide 50mg/g gel tube | 25271 | Medicine | A | 10/15/1991 |
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