Overview

• The MHRA has authorized gepotidacin (Blujepa) for uncomplicated urinary tract infections in females aged 12 or older who weigh at least 40 kg.
• The approved oral regimen is two tablets twice daily for five days, taken about 12 hours apart.
• The drug targets two bacterial enzymes, which regulators say may make it harder for bacteria to develop resistance.
• Two phase 3 trials showed gepotidacin was as effective as nitrofurantoin across more than 3,000 participants, including those with recurrent or drug‑resistant infections.
• Commonly reported side effects include diarrhoea and nausea, and the MHRA will continue safety monitoring through the Yellow Card scheme.