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Aczone (DAPSONE)
Aczone works by inhibiting bacterial growth and reducing inflammation through its sulfone properties.
Aczone (Dapsone) is a small molecule sulfone drug developed by Jacobus and currently owned by Almirall. It targets the 5-hydroxytryptamine receptor 6 and is FDA-approved since 1979 for treating acne vulgaris, dermatitis herpetiformis, and leprosy. Aczone is available as a generic medication with 19 manufacturers, indicating it is off-patent. Key safety considerations include monitoring for hemolysis, methemoglobinemia, and hypersensitivity reactions. As a sulfone, Aczone works by inhibiting bacterial growth and reducing inflammation.
At a glance
| Generic name | DAPSONE |
|---|---|
| Sponsor | Almirall |
| Drug class | Sulfone [EPC] |
| Target | 5-hydroxytryptamine receptor 6 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1979 |
Mechanism of action
The mechanism of action of dapsone gel in treating acne vulgaris is not known.
Approved indications
- Acne vulgaris
- Dermatitis herpetiformis
- Leprosy
Common side effects
- Loss of hemoglobin
- Increase in reticulocytes
- Shortened red cell life span
- Rise in methemoglobin
- Peripheral neuropathy
- Motor loss
- Nausea
- Vomiting
- Abdominal pains
- Pancreatitis
- Vertigo
- Blurred vision
Drug interactions
- didanosine
- rifampicin
Key clinical trials
- Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (PHASE3)
- A Randomized Multicenter Study for Isolated Skin Vasculitis (PHASE2)
- Randomized, Triple-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris (PHASE4)
- Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid (PHASE4)
- Chlorproguanil-Dapsone in Pregnant Women (PHASE1)
- Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients (NA)
- Dermatitis Herpetiformis Refractory to Gluten Free Diet
- Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |