Zoliflodacin is a groundbreaking, first-in-class oral antibiotic specifically developed to address the global threat of antimicrobial-resistant gonorrhea. It received U.S. Food and Drug Administration (FDA) approval on December 11, 2025, for the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older weighing at least 35 kg.