GSK's Gepotidacin Gets Priority Review for Gonorrhoea Treatment

GSK's gepotidacin has been accepted for FDA priority review as an oral treatment for uncomplicated urogenital gonorrhoea. The FDA has assigned a Prescription Drug User Fee Act action date in December 2025. Gepotidacin has already been approved for urinary tract infection treatment in the US, and review is ongoing in the UK and Australia. The development of gepotidacin has been funded in part by federal funds from the US Department of Health and Human Services.

GSK plc (LON:GSK, NYSE: GSK) has received a significant boost as the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application for gepotidacin, an oral treatment for uncomplicated urogenital gonorrhoea. The FDA has assigned a Prescription Drug User Fee Act action date in December 2025. This decision comes on the heels of positive phase III data from the EAGLE 1 trial, which demonstrated the non-inferiority of gepotidacin compared to the leading combination treatment regimen for gonorrhoea [1].

Gepotidacin's potential approval would provide a much-needed oral alternative to the current injectable treatments, which may not be suitable or available for all patients. This development is particularly timely given the growing need for new antibiotics to combat the increasing prevalence of gonorrhoea, a priority pathogen recognized by the World Health Organization [2]. The FDA's decision is expected in December 2025.

The oral treatment has already been approved in the U.S. under the brand name Blujepa for uncomplicated urinary tract infections in women and adolescent girls. The drug's development has been supported by federal funds from the U.S. Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense's Threat Reduction Agency [3].

GSK's shares were up 1.1% on Monday morning in London, reflecting investor optimism about the potential market impact of this new indication. The wider FTSE 100 index also rose by 0.4% during the same period [4].

The review of regulatory submissions for the uUTI indication is ongoing in the UK and Australia, indicating a broader interest in expanding the use of gepotidacin. This development underscores GSK's commitment to addressing public health threats and its ability to innovate in the face of significant challenges in the pharmaceutical industry.

References:
[1] Ross J et al, “Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study” in The Lancet, 2025; 405: 1608-20; https://doi.org/10.1016/S0140-6736(25)00628-2
[2] WHO. Bacterial priority pathogens list, 2024: Bacterial pathogens of public health importance to guide research, development and strategies to prevent and control antimicrobial resistance. Available at: https://www.who.int/publications/i/item/9789240093461 Last accessed: August 2025
[3] GSK. Blujepa approved by US FDA for treatment of uncomplicated urinary tract infections. Available at: https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/ Last accessed: August 2025
[4] Reuters. GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea. Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-antibiotic-gets-fda-priority-review-oral-treatment-gonorrhoea-2025-08-11/ Last accessed: August 2025