GSK plc (LON:GSK, NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older (weighing ≥45 kg). The US FDA has assigned a Prescription Drug User Fee Act action date in December 2025.
· Submission supported by positive phase III data in patients with uncomplicated urogenital gonorrhoea in EAGLE 1 trial[1]
· Significant need for new antibiotics for gonorrhoea, a priority pathogen for the World Health Organization[2]
· If approved, gepotidacin would offer a new oral option to US patients currently relying on injectable treatments
· US decision expected in December 2025
In March 2025, gepotidacin was approved by the US FDA under the licensing name Blujepa as oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).[3]
Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognised by the World Health Organization as a priority pathogen2 and an urgent public health threat by the US Centers for Disease Control and Prevention (CDC).[4] It affects both men and women and if left untreated or inadequately treated, it can lead to infertility and other sexual and reproductive health complications. There were more than 600,000 cases of gonorrhoea reported in the United States in 2023 according to the CDC, making it the second most commonly reported sexually transmitted infection in the country.[5] There is currently no vaccine licensed in the US for the prevention of gonorrhoea infection and the standard of care is injectable treatment which may not be suitable or available for all patients.[6]
The US application is based on results from the EAGLE-1 phase III trial recently published in The Lancet, showing that gepotidacin (oral, two doses of 3,000mg) was non-inferior, with 92.6% (187/202, [95% CI 88·0 to 95·8]) success rates at urogenital site when compared to 91.2% (186/204, [95% CI 86.4-94.7]) success rates for intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea. Additionally, there were no failures at the urogenital site due to bacterial persistence of N. gonorrhoeae in either treatment arm. The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in previous clinical trials, with no serious drug related adverse events observed in either the gepotidacin or the comparator arm. The most common reported adverse reactions were mild to moderate gastrointestinal events.1
This is the second major indication filed in the US for gepotidacin, and review of regulatory submissions for the uUTI indication is also ongoing in the UK and Australia.
The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the US Department of Defense’s Threat Reduction Agency under agreement number HDTRA1-07-9-0002.
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] CDC. Antibiotic Resistance Threats Report. Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf Last accessed: August 2025
[5] CDC. National Overview of STIs in 2023. Available at: https://www.cdc.gov/sti-statistics/annual/summary.html. Last accessed: August 2025
[6] CDC. STI treatment guideline. Available: https://www.cdc.gov/std/treatment-guidelines/default.htm Last accessed: August 2025
