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 18h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACZONE (dapsone) is a topical sulfone gel approved in 2005 for acne vulgaris treatment. It works through antimicrobial and anti-inflammatory mechanisms to reduce bacterial colonization and skin inflammation. The product is indicated for topical treatment of acne in patients seeking an alternative to systemic antibiotics.
$0.089MPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with minimal Part D volume ($89K in 2023), indicating a shrinking commercial footprint and likely reduced team size ahead of generic entry.
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
Photoallergy Potential of Dapsone Gel in Healthy Volunteers
Started Apr 2014
58 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.