NDATOPICALGEL
Approved
Feb 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ACZONE (dapsone) by Almirall. Approved for sulfone [epc]. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACZONE (dapsone) is a topical sulfone antibiotic gel approved in 2016 for acne vulgaris and other dermatologic conditions. It acts through bactericidal and bacteriostatic mechanisms, though its exact action in some indications remains unclear. The drug is used across multiple off-label dermatologic and systemic conditions, with broad clinical application.
$0.089MPart D
Peak7.5 years to LOEACZONE is in peak lifecycle with modest Medicare Part D penetration; commercial team size likely small relative to branded dermatology portfolio.
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
Photoallergy Potential of Dapsone Gel in Healthy Volunteers
Started Apr 2014
58 enrolled
Healthy Volunteers
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
A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Started Dec 2013
68 enrolled
Acne Vulgaris
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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.