The US FDA has approved two new oral antibiotics – zoliflodacin and gepotidacin – for the treatment of gonorrhea. Zoliflodacin oral suspension is approved for the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in adults and pediatric patients aged 12 years and older who weigh at least 35 kg. Gepotidacin oral tablets were initially approved in March 2025 for the treatment of urinary tract infections in female adult and pediatric patients aged 12 years and older.
The FDA has now expanded its indication to include the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients aged 12 years and older who weigh at least 45 kg and have limited or no alternative treatment options. 1. Zoliflodacin oral suspension Clinical evidence The safety and efficacy of zoliflodacin were evaluated in a clinical trial involving 930 patients with…
