LOPROX
Loprox (ciclopirox) Topical Solution, 8%, is indicated as a component of a comprehensive management program for the topical treatment of mild-to-moderate onychomycosis of the fingernails and toenails (without lunula involvement) caused by *Trichophyton rubrum* in immunocompetent patients. This comprehensive program must include the frequent removal (as often as monthly) of unattached, infected nails by a healthcare professional. The safety and efficacy of daily use beyond 48 weeks have not been established, and it has not been studied in patients with insulin-dependent diabetes, immunosuppression, or severe plantar tinea pedis.
How LOPROX Works
Ciclopirox is a hydroxypyridone antifungal agent that acts through a unique mechanism compared to azoles or allylamines. It functions primarily by chelating polyvalent cations ($Fe^{3+}$ and $Al^{3+}$), which results in the inhibition of metal-dependent enzymes within the fungal cell. These enzymes (such as cytochromes, catalase, and peroxidase) are essential for mitochondrial respiration, cellular transport, and the degradation of toxic peroxides. The resulting disruption of these metabolic processes leads to the loss of fungal cell membrane integrity and cell death.
Details
- Status
- Prescription
- First Approved
- 1982-12-30
- Routes
- TOPICAL
- Dosage Forms
- CREAM, SUSPENSION, SHAMPOO
LOPROX Approval History
What LOPROX Treats
1 indicationsLOPROX is approved for 1 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Onychomycosis
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Active Pipeline
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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.
LOPROX FDA Label Details
ProIndications & Usage
FDA Label (PDF)(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of n...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.