Clinical Medicine Reviews in Therapeutics

The management of skin and soft-tissue infections caused by multidrug resistant Gram-positive organisms, specifically methicillin-resistant Staphylococcus aureus (MRSA), continues to be a significant challenge for clinicians. Iclaprim is a diaminopyrimidine that has shown potent activity against various Gram-positive organisms, including MRSA, with limited Gram-negative activity similar to that of trimethoprim. Iclaprim has completed two Phase III trials with a submission of New Drug Application to the United States Food and Drug Administration (FDA) in 2008. Subsequently, a complete response letter not supporting the approval of iclaprim was released by the FDA. More recently, Acino Holding Ltd. has acquired the shares and data to iclaprim. Pending final draft guidance from the FDA for future studies, iclaprim may have a role in the management of skin and soft-tissue infections. A Medline search of articles through February 2011 and references of selected citations was conducted. Data from abstracts presented at the International Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America annual meetings were also appraised. This article reviews the antimicrobial profile, pharmacokinetic and pharmacodynamic properties, and available clinical data of iclaprim.