CICLOPIROX
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) in immunocompetent patients, specifically when caused by *Trichophyton rubrum*. The comprehensive management program requires 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. It has not been studied in patients who are pregnant, nursing, immunocompromised, or those with insulin-dependent diabetes or diabetic neuropathy.
How CICLOPIROX Works
Ciclopirox is a broad-spectrum antifungal agent that operates through a unique mechanism compared to azoles or allylamines. It acts primarily by chelating polyvalent cations ($Fe^{3+}$ and $Al^{3+}$), which results in the inhibition of metal-dependent enzymes within the fungal cell, such as cytochromes, catalase, and peroxidase. These enzymes are essential for mitochondrial electron transport and the cellular degradation of peroxides. Furthermore, ciclopirox disrupts fungal cell membrane integrity by inhibiting the transport of essential nutrients (amino acids) and electrolytes, leading to fungal cell death.
Details
- Status
- Prescription
- First Approved
- 1997-07-21
- Routes
- TOPICAL
- Dosage Forms
- SUSPENSION, SHAMPOO, CREAM, SOLUTION, GEL
Companies
CICLOPIROX Approval History
What CICLOPIROX Treats
1 indicationsCICLOPIROX is approved for 1 conditions since its original approval in 1997. 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.
CICLOPIROX 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.