The Medicines and Healthcare products Regulatory Agency (MHRA)
has approved gepotidacin (Blujepa), a new kind of oral antibiotic
pill to treat uncomplicated urinary tract infections (UTIs) in
females aged 12 years and older, weighing at least 40 kg.
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.
The active ingredient in the antibiotic targets and blocks two
enzymes that bacteria need to replicate and multiply, making it
effective against many drug resistant infections such as E.
coli.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access,
said:
“Keeping patients safe and enabling their access to high quality,
safe and effective medicines are key priorities for us.
“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.”
The recommended dose is two tablets twice daily for five days,
approximately every 12 hours.
The MHRA's national approval is supported by evidence from two
multicentre, randomised, active-controlled Phase 3 trials in
females with uncomplicated UTIs, where 1572 participants were
given gepotidacin and 1564 received nitrofurantoin, the frontline
antibiotic currently used to treat uncomplicated
UTIs.
In both trials, gepotidacin was shown to be at least as effective
as 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 1 in 10 people) include diarrhoea and nausea, both of
which were considered mild. A full list of side effects can be
found in the Patient Information Leaflet (PIL) or the Summary of
Product Characteristics (SmPC).
The approval of this gepotidacin follows a rigorous assessment to
ensure that it meets the required regulatory standards. As with
all medicines, the MHRA will continue to monitor its safety and
effectiveness.
Anyone who suspects they are having a side effect from this
medicine are encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the Yellow Card scheme, either
through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
The new marketing authorisation was granted on 27 August 2025
to GSK plc.
-
The approval of gepotidacin is based on two multicentre,
randomised, active-controlled Phase 3 trials – large
international studies where participants with uncomplicated
UTIs were randomly assigned to receive either gepotidacin or
the standard treatment, allowing researchers to compare how
well the antibiotic worked.
-
More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA
Products website within 7 days of approval.
-
For more information about UTIs, visit: www.nhs.uk/conditions/urinary-tract-infections-utis/
