The US FDA has assigned a Prescription Drug User Fee Act action date of December 11, 2025. In March 2025, gepotidacin was approved by the US FDA under the licensing name Blujepa (1,500mg administered orally twice daily for five days) as oral treatment for female adult and pediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).
Gonorrhea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognized 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). 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 gonorrhea reported in the United States in 2023 according to the CDC, making it the second most commonly reported sexually transmitted infection in the country. There is currently no vaccine licensed in the US for the prevention of gonorrhea infection and the standard of care is injectable treatment which may not be suitable or available for all patients.
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 gonorrhea. 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 (45% Grade 1) to moderate (29% Grade 2) gastrointestinal events.
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.
About gepotidacin
Gepotidacin, discovered by GSK scientists, is a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action, and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against Neisseria gonorrhoeae and most target uropathogens (such as Escherichia coli and Staphylococcus saprophyticus), including isolates resistant to current antibiotics. Due to this well-balanced inhibition for most pathogens, a single target-specific mutation may not significantly impact gepotidacin activity.
About the EAGLE clinical program
The EAGLE-1 trial (NCT04010539) is part of a comprehensive global phase III clinical program for gepotidacin in adults and adolescents including:
EAGLE-1 (non-inferiority urogenital gonorrhea trial) compared the efficacy and safety of gepotidacin (oral, two doses of 3,000mg) to intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) in approximately 600 patients with uncomplicated urogenital gonorrhea. The data were presented at ESCMID in April 2024 and published in The Lancet in April 2025.
EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days). The data were first presented at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in 2023.
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