CICLOPIROX
LOE ApproachingNDATOPICALGEL
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
CICLOPIROX by Alvogen is clinical pharmacology microbiology mechanism of action the mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. First approved in 1997.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Ciclopirox is a topical hydroxypyridone antifungal gel approved in 1997 for fungal infections of the skin and nails. It works by chelating polyvalent cations (Fe or Al) to inhibit metal-dependent enzymes responsible for fungal cell peroxide degradation. The drug demonstrates strong dermal penetration with minimal systemic absorption (1.3% topically).
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting consolidation or transition planning for the brand team.
Mechanism of Action
CLINICAL PHARMACOLOGY Microbiology Mechanism of Action The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe or Al) resulting in the inhibition of the…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.