07:14 AM EDT, 08/11/2025 (MT Newswires) -- GSK (GSK) said Monday the US Food and Drug Administration has accepted for priority review a supplemental new drug application for gepotidacin for the oral treatment for uncomplicated urogenital gonorrhoea in patients 12 years and older, with a decision expected by Dec. 11.

The drug could provide an alternative to current injectable treatments for the sexually transmitted infection, the company said.

The submission is supported by phase 3 trial data showing a 92.6% success rate for gepotidacin, compared to 91.2% for standard combination therapy, with no cases of bacterial persistence, GSK said.

The treatment was well-tolerated with mostly mild to moderate gastrointestinal side effects and no serious drug-related adverse events, the company said.

Gepotidacin is also under review in the UK and Australia for urinary tract infection, GSK added.