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Dapsone 7.5 % gel
Dapsone 7.5 % gel is a Sulfone antibiotic with anti-inflammatory properties Small molecule drug developed by Derm Research, PLLC. It is currently FDA-approved for Acne vulgaris, Rosacea, Dermatitis herpetiformis. Also known as: Aczone, topical dapsone 7.5% gel, Vulgarex (country-specific brand).
Dapsone is a sulfone antibiotic that inhibits bacterial dihydropteroate synthase and has anti-inflammatory properties, reducing neutrophil migration and suppressing inflammatory mediators.
Dapsone 7.5% gel is a small molecule inhibitor of dihydropteroate synthase 1, classified as an INHIBITOR. It is used to treat Acne Vulgaris, specifically in patients with skin of color, as indicated by clinical trials.
At a glance
| Generic name | Dapsone 7.5 % gel |
|---|---|
| Also known as | Aczone, topical dapsone 7.5% gel, Vulgarex (country-specific brand) |
| Sponsor | Derm Research, PLLC |
| Drug class | Sulfone antibiotic with anti-inflammatory properties |
| Target | Dihydropteroate synthase; neutrophil function and inflammatory mediators |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Dapsone works through dual mechanisms: it interferes with bacterial folate synthesis by inhibiting dihydropteroate synthase, making it bacteriostatic against susceptible organisms. Additionally, it possesses immunomodulatory and anti-inflammatory effects by suppressing neutrophil function and reducing the production of inflammatory cytokines, which is particularly beneficial in inflammatory skin conditions.
Approved indications
- Acne vulgaris
- Rosacea
- Dermatitis herpetiformis
Common side effects
- Erythema
- Dryness
- Irritation at application site
- Photosensitivity
Key clinical trials
- Randomized, Triple-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris (PHASE4)
- Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color (PHASE4)
- DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS (PHASE4)
- Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE3)
- Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris (PHASE4)
- Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris (PHASE4)
- Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE1)
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:
- Dapsone 7.5 % gel CI brief — competitive landscape report
- Dapsone 7.5 % gel updates RSS · CI watch RSS
- Derm Research, PLLC portfolio CI
Frequently asked questions about Dapsone 7.5 % gel
What is Dapsone 7.5 % gel?
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Related
- Drug class: All Sulfone antibiotic with anti-inflammatory properties drugs
- Target: All drugs targeting Dihydropteroate synthase; neutrophil function and inflammatory mediators
- Manufacturer: Derm Research, PLLC — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris
- Indication: Drugs for Rosacea
- Indication: Drugs for Dermatitis herpetiformis
- Also known as: Aczone, topical dapsone 7.5% gel, Vulgarex (country-specific brand)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing