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dapsone gel
Dapsone gel, marketed by Almirall, S.A., is an FDA-approved topical treatment for acne vulgaris. The drug's key strength lies in its unique mechanism of action, which differentiates it from other acne treatments. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | dapsone gel |
|---|---|
| Also known as | ACZONE, ACZONE® (dapsone) Gel, 5%, Aczone® |
| Sponsor | Almirall, S.A. |
| Drug class | Sulfone [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
- Acne vulgaris
Common side effects
- Application Site Reaction NOS
- Application Site Dryness
- Dryness
- Application Site Erythema
- Oiliness/Peeling
- Erythema
- Nasopharyngitis
- Headache NOS
- Upper Respiratory Tract Infection NOS
- Pharyngitis
- Cough
- Sinusitis NOS
Serious adverse events
- Depression
- Psychosis
- Facial Swelling
- Methemoglobinemia
- Rash (including erythematous rash, application site rash)
- Swelling of Face (including lip swelling, eye swelling)
- Suicide Attempt
- Pancreatitis
- Severe Vomiting
- Severe Pharyngitis
Key clinical trials
- Randomized, Triple-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris (PHASE4)
- Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris (PHASE2)
- Effect of New Topical Preparation for Treatment of Acne Vulgaris (PHASE2)
- 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)
- Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage. (PHASE3)
- 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)
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 gel CI brief — competitive landscape report
- dapsone gel updates RSS · CI watch RSS
- Almirall, S.A. portfolio CI