NDATOPICALGEL
Approved
Jul 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ACZONE (dapsone) by Almirall. Approved for sulfone [epc]. First approved in 2005.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACZONE (dapsone) is a topical gel sulfone antibiotic approved in 2005 for acne vulgaris, with off-label use across multiple dermatologic and oncologic indications including rosacea, PCP prophylaxis, and cetuximab-induced rashes. The mechanism in acne remains incompletely understood, though dapsone demonstrates bactericidal and bacteriostatic activity against Mycobacterium leprae with slow excretion enabling sustained blood levels. Patients typically receive topical application, achieving steady-state concentrations within 8 days of daily dosing.
$89KPart D
LOE ApproachingDeclining
Minimal commercial footprint with LOE approaching indicates reduced team investment and limited career growth runway; consolidation or divestiture likely in mid-term horizon.
Mechanism of Action
Pharmacologic Class:
Sulfone
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Started Oct 2016
100 enrolled
Acne Vulgaris
Phototoxicity Test of Dapsone Gel in Healthy Volunteers
Started Apr 2014
33 enrolled
Healthy Volunteers
Dermal Tolerability of Dapsone Gel in Healthy Volunteers
Started Apr 2014
237 enrolled
Healthy Volunteers
Photoallergy Potential of Dapsone Gel in Healthy Volunteers
Started Apr 2014
58 enrolled
Healthy Volunteers
A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Started Dec 2013
68 enrolled
Acne Vulgaris
Worked on ACZONE at Almirall? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.