Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that it has secured US Food and Drug Administration priority review for a supplemental New Drug Application for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 years and older weighing at least 45kg. A decision is expected in December 2025.

The application is backed by phase III EAGLE-1 trial data, published in The Lancet, showing gepotidacin achieved a 92.6% cure rate at the urogenital site, comparable to the 91.2% rate for current standard therapy of intramuscular ceftriaxone plus oral azithromycin. No bacterial persistence was observed in either treatment arm, and the drug demonstrated a favourable safety profile with only mild to moderate gastrointestinal side effects.

Gonorrhoea, caused by Neisseria gonorrhoeae, is a World Health Organization priority pathogen and a US Centers for Disease Control and Prevention urgent public health threat. Over 600,000 US cases were reported in 2023, with no licensed vaccine available and treatment currently limited to injectable options.

This marks the second major US indication filed for gepotidacin, following its March 2025 FDA approval under the name Blujepa for uncomplicated urinary tract infections. Regulatory reviews for that indication are ongoing in the UK and Australia. Development of gepotidacin has been partially funded by the US Department of Health and Human Services and the US Department of Defense.