Gepotidacin in uncomplicated urinary tract infections and uncomplicated urogenital gonorrhoea: a profile of its use

Gepotidacin (BLUJEPA), a first-in-class triazaacenaphthylene inhibitor of type II bacterial topoisomerases, is a useful addition to the antimicrobials currently approved in the USA and UK for the treatment of uncomplicated urinary tract infections (uUTIs) in female adult and paediatric patients ≥ 12 years of age weighing ≥ 40 kg, and in the USA for the treatment of uncomplicated urogenital gonorrhoea (uUG) in adult and paediatric patients ≥ 12 years of age weighing ≥ 45 kg who have limited or no alternative treatment options. In the pivotal phase 3 EAGLE-2 and EAGLE-3 trials in uUTIs, gepotidacin was non-inferior to nitrofurantoin for achieving patient therapeutic responses (combined clinical and microbiological success) and superior to nitrofurantoin in EAGLE-3. Additionally, in the pivotal phase 3 EAGLE-1 trial in the treatment of uUG, gepotidacin was non-inferior to ceftriaxone plus azithromycin in achieving microbiological success. The tolerability of gepotidacin was acceptable, with gastrointestinal events being the most common type of adverse event. New antimicrobials are needed to combat rising rates of antimicrobial resistance among bacteria that cause diseases, such as urinary tract infection and gonorrhoea. Gepotidacin (BLUJEPA) is the first in a new class of antimicrobials that targets type II bacterial topoisomerases, and has been approved for treatment of uncomplicated urinary tract infections (uUTIs) in female patients ≥ 12 years of age and weighing ≥ 40 kg in the USA and UK, as well as for the treatment of uncomplicated urogenital gonorrhoea (uUG) in patients ≥ 12 years of age and weighing ≥ 45 kg who have limited or no alternative treatment options in the USA. In clinical trials, gepotidacin was non-inferior to first-line treatments nitrofurantoin for uUTIs and ceftriaxone plus azithromycin for uUG. It had at least as good or better rates of therapeutic success (measured by combined symptomatic cure and eradication of the disease-causing bacteria) in the treatment of uUTIs, and at least as good rates of bacterial eradication for uUG compared with first-line treatments. Gepotidacin had acceptable tolerability, with diarrhoea, nausea and abdominal pain being the most common adverse events. Overall, gepotidacin is a useful addition to the antimicrobials currently available to treat patients with uUTIs and uUG.