VUSION (miconazole nitrate)
Vusion is a topical ointment indicated for the adjunctive treatment of diaper dermatitis in immunocompetent pediatric patients 4 weeks and older when the condition is complicated by documented candidiasis. Diagnosis must be established by microscopic evidence (pseudohyphae and/or budding yeast), as a positive fungal culture alone is insufficient. It should be used as part of a treatment regimen that includes frequent diaper changes and gentle cleansing. Vusion is not indicated for the prevention of diaper dermatitis, as prophylactic use may lead to drug resistance.
How VUSION Works
Vusion contains miconazole nitrate, an antifungal agent that addresses the underlying candidal infection. While miconazole provides antifungal activity, the exact mechanism of action for the zinc oxide and white petrolatum components in the adjunctive treatment of diaper dermatitis remains unknown.
Details
- Status
- Prescription
- First Approved
- 2006-02-16
- Patent Cliff
- 2028
- Routes
- TOPICAL
- Dosage Forms
- OINTMENT
VUSION Approval History
What VUSION Treats
2 indicationsVUSION is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diaper Dermatitis
- Candidiasis
VUSION 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 VUSION
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07565181 ZO-RAS | OMDR_105_1q | Ph 4 | completed | Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis |
| NCT07193849 | 23-1032 23071104 | Ph 4 | recruiting | Zinc Oxide VS MEBO |
| NCT03359070 | GDN 042/13 | Ph 2 | completed | Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris |
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.
VUSION FDA Label Details
Indications & Usage
FDA Label (PDF)VUSION is indicated for the treatment of Diaper Dermatitis; Candidiasis.
VUSION Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for VUSION
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.