GSK plc (GSK) has sought FDA approval of Gepotidacin for its second major indication – as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older weighing at least 45kg, and a decision is anticipated on December 11, 2025. Gonorrhoea is a common sexually transmitted infection caused by Neisseria gonorrhoeae. It affects both men and women and, if left untreated or improperly treated, can lead to infertility and other sexual and reproductive health complications. According to the Centers for Disease Control and Prevention, there were over 600,000 reported cases of Gonorrhoea in the United States in 2023, making it the second most commonly reported sexually transmitted infection in the country. Currently, there is no licensed vaccine in the US, and the standard treatment is an injectable therapy, which may not be suitable or accessible for all patients.Gepotidacin, marketed under the brand name Blujepa, received FDA approval this March as an oral treatment for uncomplicated urinary tract infections in female adult and pediatric patients aged 12 and older weighing at least 40 kg.GSK closed Wednesday’s (November 26, 2025) trading at $48.02, up 0.99%.