GYNAZOLE-1 (butoconazole nitrate)
GYNAZOLE-1 is indicated for the treatment of Vulvovaginal Candidiasis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-05-18
- Routes
- VAGINAL
- Dosage Forms
- CREAM
GYNAZOLE-1 Approval History
What GYNAZOLE-1 Treats
1 indicationsGYNAZOLE-1 is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vulvovaginal Candidiasis
GYNAZOLE-1 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.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05031481 | EMS1819 - VENUS | Ph 2 | withdrawn | Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis. |
| NCT00616330 | CBC-302-602-622467 | Ph 3 | completed | Vaginal Infection Study |
| NCT00694928 | CBC-303-603-622467 | Ph 3 | completed | Vaginal Infection Study 2 |
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.
GYNAZOLE-1 FDA Label Details
Indications & Usage
GYNAZOLE-1 is indicated for the treatment of Vulvovaginal Candidiasis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment