MHRA approves first new UTI antibiotic in 30 years

An oral antibiotic for urinary tract infections (UTIs) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), marking the first new UTI antibiotic for 30 years.

Gepotidacin (Blujepa; GSK) is a new type of antibiotic, which involves a triazaacenaphthylene that inhibits two type II topoisomerase enzymes, in what GSK said is a “novel mechanism of action”.

On 27 August 2025, the MHRA approved the medicine for uncomplicated UTIs in females aged 12 years and over, who weigh at least 40kg.

GSK added that Blujepa works against “most target uropathogens, such as Escherichia coli and Staphylococcus saprophyticus, including isolates resistant to current antibiotics”.

Around half of all women will experience an uncomplicated UTI in their lifetime, and UTIs account for between 1–3% of GP appointments each year.

It is also estimated that treatment for UTIs make up approximately 15–20% of antibiotics prescribed in primary care each year.

In addition, up to 50% of the bacteria that cause UTIs show resistance to at least one antibiotic.

Julian Beach, interim executive director of healthcare quality and access at the MHRA, 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 UTIs 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.”

The MHRA said its decision was supported by two phase III trials that showed gepotidacin was at least as effective as nitrofurantoin — a current frontline antibiotic in treating uncomplicated UTIs — including in patients with recurrent infections and drug-resistant bacteria.

Louise Dunsmure, chair of the Royal Pharmaceutical Society’s Antimicrobial Expert Advisory Group, said: “A new antibiotic for the management of uncomplicated UTIs in females is a welcome addition to the treatment options available for this common infection. However, it’s important to manage expectations as gepotidacin will not be suitable for everyone.

“Integrated care boards have treatment guidelines for UTIs, both in primary and secondary care, and the place for gepotidacin in these guidelines will need to be reviewed.

“Early studies show it can be effective, but there needs to be balance of innovation and antimicrobial stewardship. Like all new medicines, there are potential side effects and uncertainties around how resistance will develop in real-world use. Careful governance and evaluation will be essential before it is adopted more widely.”

In August 2025, Dunsmure co-authored a Pharmaceutical Journal learning article on the diagnosis, management and prevention of urinary tract infection in adults, which noted that optimising UTI management and clinical outcomes helped to support the UK’s 20-year vision for antimicrobial resistance.