CLOTIC (clotrimazole)
CLOTIC is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis.
Details
- Status
- Prescription
- First Approved
- 2025-09-26
- Patent Cliff
- 2042
- Routes
- OTIC
- Dosage Forms
- SOLUTION/DROPS
CLOTIC Approval History
What CLOTIC Treats
3 indicationsCLOTIC is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tinea Pedis
- Tinea Cruris
- Tinea Corporis
CLOTIC 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 CLOTIC
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03005353 | CSE | Ph 2, Ph 3 | completed | Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories. |
| NCT03115073 | ProF-001_Phase IIa | Ph 2, Ph 3 | completed | ProF-001_Phase IIa |
| NCT02847286 | IPM 036 | Ph 1 | completed | To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%) |
| NCT01993823 results posted | G238OTIII/11IA01 | Ph 3 | completed | Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis |
| NCT02713139 Frauen | ACH-CLP-03(05/12) | Ph 3 | withdrawn | Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies. |
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.
CLOTIC FDA Label Details
Indications & Usage
FDA Label (PDF)CLOTIC is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis.
CLOTIC Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CLOTIC
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 17 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.