HQ Team
August 28, 2025: Britain’s Medicines and Healthcare products Regulatory Agency has approved GSK Plc’s Blujepa, an oral antibiotic pill to treat uncomplicated urinary tract infections in females above 12 years and older, weighing at least 40 kilograms.
The drug, gepotidacin, branded as Blujepa, targets and blocks two enzymes that bacteria need to replicate and multiply, making it effective against many drug-resistant infections such as E. coli, according to an agency statement.
The recommended dose is two tablets twice daily for five days, approximately every 12 hours.
Uncomplicated UTIs are the most common bacterial infection in women, affecting around half of females in the UK. With drug-resistant bacteria increasing, new treatment options are critical in preventing treatment failure and complications, including sepsis or permanent kidney damage.
‘Impact daily life’
“As the first new type of oral antibiotic to treat uncomplicated UTIs to be approved in nearly three decades, gepotidacin provides a new treatment option for women facing urinary tract infections that can severely impact daily life,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.
“The antibiotic’s targeted mechanism of action makes it more difficult for bacteria to develop treatment resistance – a crucial factor as drug-resistant bacteria are increasingly on the rise globally,” he said.
The MHRA’s approval is supported by evidence from two multicentre, randomised, active-controlled end-stage trials in females with uncomplicated UTIs, where 1,572 participants were given gepotidacin and 1,564 received nitrofurantoin, the frontline antibiotic currently used to treat uncomplicated UTIs.
In both trials, gepotidacin was shown to be at least as effective as the antibiotic nitrofurantoin. Results were consistent across patient groups, including those with recurrent infections and with drug-resistant bacteria.
The most common side effects of the medicine (which may affect more than one in 10 people) include diarrhoea and nausea, both of which were considered mild. The MHRA will continue to monitor the medicine’s safety and effectiveness.
