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Ciclopirox 8%
Ciclopirox is a broad-spectrum antifungal agent that inhibits fungal enzyme systems by chelating polyvalent cations, disrupting cellular respiration and biosynthesis.
Ciclopirox is a broad-spectrum antifungal agent that inhibits fungal enzyme systems by chelating polyvalent cations, disrupting cellular respiration and biosynthesis. Used for Onychomycosis (fungal nail infection), Tinea pedis, tinea corporis, and other dermatophyte infections, Candida and other fungal skin infections.
At a glance
| Generic name | Ciclopirox 8% |
|---|---|
| Sponsor | MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA |
| Drug class | Topical antifungal agent |
| Target | Fungal cytochrome P450 enzymes and polyvalent cation-dependent metalloenzymes |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Ciclopirox works by forming a complex with trivalent cations (iron and aluminum) that are essential cofactors for fungal cytochrome P450 enzymes and other metalloenzymes. This inhibition disrupts multiple metabolic pathways including energy production, nucleic acid synthesis, and cell wall integrity. The 8% formulation is typically used as a topical treatment for fungal infections of the skin and nails.
Approved indications
- Onychomycosis (fungal nail infection)
- Tinea pedis, tinea corporis, and other dermatophyte infections
- Candida and other fungal skin infections
Common side effects
- Local irritation or burning at application site
- Erythema
- Pruritus
- Contact dermatitis
Key clinical trials
- Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes. (NA)
- Diode Laser and Photodynamic Therapy Vs. Ciclopirox. (PHASE4)
- Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (PHASE4)
- Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis (PHASE3)
- Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ciclopirox 8% CI brief — competitive landscape report
- Ciclopirox 8% updates RSS · CI watch RSS
- MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA portfolio CI