Ciclopirox 8% nail lacquer has recently become the first topical antifungal agent to be approved by the US Food and Drug Administration for the treatment of onychomycosis. This article reviews the results of the two pivotal clinical trials of this drug that have been performed in the United States as well as those that have been carried out in other countries. The two US studies were both double-blind, vehicle-controlled, parallel-group, multicenter studies designed to determine the efficacy and safety of ciclopirox nail lacquer in the treatment of mild-to-moderate onychomycosis of the toenails caused by dermatophytes. The combined results show a 34% mycologic cure rate, as compared with 10% for the placebo. Data from the ten studies conducted worldwide show a meta-analytic mean (+/- SE) mycologic cure rate of 52.6% +/- 4.2%. As expected for a topical agent, ciclopirox nail lacquer was found to be extremely safe, with mild, transient irritation at the site of application reported as the most common adverse event. Ciclopirox nail lacquer may also have potential for use in combination or adjunctive therapy. Further studies will help to better position this agent for the treatment of this widespread podiatric condition.