GSK Press Release, 25 March 2025

The US FDA has approved Blujepa (gepotidacin), a first-in-class oral antibiotic, for treating uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients (≥12 years, ≥40 kg). 

GSK researchers discovered the drug, which targets Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.


How It Works

Blujepa is a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication through a novel mechanism. 
It binds to a distinct site on two Type II topoisomerase enzymes, providing well-balanced inhibition against most target uropathogens, including Escherichia coli and Staphylococcus saprophyticus, as well as Neisseria gonorrhoeae, even those resistant to current antibiotics.

This dual inhibition reduces the likelihood of resistance development, as mutations in both enzymes are required to impact susceptibility. Its efficacy and safety have been demonstrated in phase III trials for uUTIs and gonorrhoea, including in patients with drug-resistant pathogens.


Clinical Trials and Efficacy

Approval was based on phase III EAGLE-2 and EAGLE-3 trials, which showed Blujepa’s effectiveness against uUTIs. 

In EAGLE-2, Blujepa demonstrated non-inferiority to nitrofurantoin, achieving a 50.6% therapeutic success rate compared to 47.0% for nitrofurantoin. 

In EAGLE-3, Blujepa showed statistically significant superiority, with a 58.5% success rate versus 43.6% for nitrofurantoin.


Safety Profile

The most common adverse events were gastrointestinal (GI) issues, including diarrhoea (16%) and nausea (9%). Most GI events were mild (69%) or moderate (28%), with severe cases occurring in less than 1% of participants. Serious drug-related adverse events were rare, with one case reported in each treatment arm.

GSK plans to launch Blujepa commercially in the US in the second half of 2025.