UK Regulator Approves First New UTI Antibiotic in 30 Years

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved gepotidacin (Blujepa), the first new oral antibiotic in nearly 30 years to treat uncomplicated urinary tract infections (UTIs) in females aged 12 and older weighing at least 40 kg. This antibiotic targets and blocks two bacterial enzymes critical for replication, making it effective against drug-resistant bacteria such as E. coli and reducing the risk of resistance development. Clinical trials involving over 3,000 participants demonstrated that gepotidacin is at least as effective as nitrofurantoin, the current frontline treatment, including in cases with recurrent infections and antibiotic-resistant strains. The standard dosage is two tablets taken twice daily for five days. Given the rising prevalence of drug-resistant UTIs, gepotidacin offers an important new treatment option that could help prevent severe complications like sepsis and kidney damage. Before its NHS adoption, the drug's cost-effectiveness will be assessed by the National Institute for Health and Care Excellence.