Nafithromycin: a pharmacological and microbiological overview of a new-generation lactone-ketolide for combating antimicrobial resistance

There has been a rapid increase in antimicrobial resistance, particularly among respiratory pathogens, which poses a serious global challenge to the effective treatment of infectious diseases. Nafithromycin is a next-generation macrolide antibiotic and India’s first indigenously developed drug in this class, representing a major therapeutic breakthrough after more than three decades. Based on its chemical structure, nafithromycin is categorized as a lactone-ketolide. This agent demonstrates favorable pharmacokinetic and pharmacodynamic properties along with enhanced hepatic safety when compared to earlier ketolides. Nafithromycin also exhibits improved ribosomal binding and excellent lung tissue penetration. This review focuses on the pharmacological and microbiological aspects of nafithromycin, including its antimicrobial spectrum, safety profile, clinical trial data, and overall tolerability.