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Benzoyl peroxide 5% gel
Benzoyl peroxide 5% gel is a Topical antimicrobial and keratolytic agent Small molecule drug developed by University of Southern California. It is currently FDA-approved for Acne vulgaris (mild to moderate).
Benzoyl peroxide kills acne-causing bacteria and promotes skin cell turnover by generating reactive oxygen species.
Benzoyl peroxide kills acne-causing bacteria and promotes skin cell turnover by generating reactive oxygen species. Used for Acne vulgaris (mild to moderate).
At a glance
| Generic name | Benzoyl peroxide 5% gel |
|---|---|
| Sponsor | University of Southern California |
| Drug class | Topical antimicrobial and keratolytic agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Benzoyl peroxide is a potent oxidizing agent that penetrates the skin and decomposes to produce oxygen radicals, which are bactericidal against Cutibacterium acnes (formerly Propionibacterium acnes). It also has keratolytic properties that help shed dead skin cells and reduce comedone formation. The 5% concentration provides a balance between efficacy and tolerability for topical acne treatment.
Approved indications
- Acne vulgaris (mild to moderate)
Common side effects
- Skin irritation and erythema
- Dryness and peeling
- Contact dermatitis
- Bleaching of hair or fabrics
Key clinical trials
- Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study (PHASE2)
- Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris (NA)
- Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne (PHASE4)
- Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations (NA)
- Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne (PHASE1, PHASE2)
- Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty (PHASE4)
- A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor (PHASE4)
- Efficacy and Tolerance of Formula 609613 37 in Acneic Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Benzoyl peroxide 5% gel CI brief — competitive landscape report
- Benzoyl peroxide 5% gel updates RSS · CI watch RSS
- University of Southern California portfolio CI
Frequently asked questions about Benzoyl peroxide 5% gel
What is Benzoyl peroxide 5% gel?
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Related
- Drug class: All Topical antimicrobial and keratolytic agent drugs
- Manufacturer: University of Southern California — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris (mild to moderate)
- Compare: Benzoyl peroxide 5% gel vs similar drugs
- Pricing: Benzoyl peroxide 5% gel cost, discount & access