Dapsone is a sulfone indicated for the treatment of dermatitis herpetiformis (DH) and all clinical forms of leprosy. It is not indicated for cases of leprosy with proven dapsone resistance. It is utilized for the long-term management of these chronic inflammatory and infectious conditions.
How DAPSONE Works
The mechanism of action for dapsone in the treatment of dermatitis herpetiformis has not been established. In leprosy, dapsone exhibits both bactericidal and bacteriostatic activity against *Mycobacterium leprae*, as demonstrated by kinetic studies in mice. This antimicrobial activity inhibits the growth and viability of the causative organism.
Details
- Status
- Prescription
- First Approved
- 1979-07-03
- Routes
- TOPICAL, ORAL
- Dosage Forms
- GEL, TABLET
Companies
DAPSONE Approval History
What DAPSONE Treats
2 indicationsDAPSONE is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatitis Herpetiformis
- Leprosy
DAPSONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DAPSONE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02939573 ARAMIS | VCRC5562 U54AR057319 | Ph 2 | recruiting | A Randomized Multicenter Study for Isolated Skin Vasculitis |
| NCT05984381 | AIIMS BBSR/PG Thesis/2023-24 | Ph 4 | completed | Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid |
| NCT01165840 results posted | AMAIRB97 5UL1RR024982-02 | Ph 4 | completed | Effect of Weight and/or Obesity on Dapsone Drug Concentrations |
| NCT00834210 results posted | MA-ACZ0802 | Ph 4 | completed | Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DAPSONE FDA Label Details
Indications & Usage
FDA Label (PDF)Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
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ACZONE
Full clinical data, patents, trials, and competitive landscape for dapsone.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.