GSK’s gepotidacin approved by U.K. MHRA

The U.K.’s Medicines and Healthcare products Regulatory Agency, MHRA, has approved GSK‘s (GSK) gepotidacin, also known as Blujepa, a new kind of oral antibiotic pill to treat uncomplicated urinary tract infections in females aged 12 years and older, weighing at least 40kg. 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.