CLOTRIMAZOLE · SUN PHARMA CANADA
INDICATIONS & USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur .
Details
- Status
- Prescription
- First Approved
- 1975-02-03
- Routes
- VAGINAL, ORAL, TOPICAL
- Dosage Forms
- CREAM, TROCHE/LOZENGE, SOLUTION
Companies
CLOTRIMAZOLE Approval History
What CLOTRIMAZOLE Treats
5 indicationsCLOTRIMAZOLE is approved for 5 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
- Tinea Versicolor
- Tinea Pedis
- Tinea Cruris
- Tinea Corporis
CLOTRIMAZOLE 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 CLOTRIMAZOLE
3 of 20FDA-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| NCT02713139 Frauen | ACH-CLP-03(05/12) | Ph 3 | withdrawn | Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.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.
CLOTRIMAZOLE FDA Label Details
Indications & Usage
INDICATIONS & USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis .
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Full clinical data, patents, trials, and competitive landscape for clotrimazole.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.