The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to GSK’s oral antibiotic pill, Blujepa (gepotidacin), for uncomplicated urinary tract infections (UTIs) in females who are aged 12 years and above with a minimum body weight of 40kg.
Blujepa’s active ingredient inhibits two critical enzymes required by bacteria for replication, thereby proving potent against numerous infections that are resistant to drugs, including strains of E. coli.
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The prescribed regimen for Blujepa involves the consumption of two pills every 12 hours over a five-day period.
The MHRA’s endorsement of the oral therapy is based on the outcomes from two active-controlled, randomised Phase III trials, which were conducted across multiple centres.
These trials involved 1,572 subjects who were administered gepotidacin while 1,564 participants were given nitrofurantoin, the standard antibiotic for treating uncomplicated UTIs.
Consistent results were observed across various patient demographics, including those with recurrent infections and those caused by drug-resistant bacteria.
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By GlobalDataThe most frequently reported adverse effects, affecting more than one in ten individuals, were nausea and diarrhoea, both of which were classified as mild.
Given that uncomplicated UTIs represent the most prevalent bacterial infection among women in the UK, with approximately half of the female population affected, the emergence of drug-resistant bacteria has underscored the necessity for new therapeutic avenues, according to the MHRA.
These alternatives are crucial to avert treatment failures and severe complications such as sepsis or irreversible kidney damage.
MHRA Healthcare Quality and Access interim executive director Julian Beach said: “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.
“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.”
In April 2025, the MHRA approved GSK’s Blenrep, a treatment for multiple myeloma.
