FDA Greenlights Gepotidacin: The First New Oral Antibiotic for UTIs in 30 Years

A breakthrough in the fight against antimicrobial resistance: The US FDA has approved gepotidacin (Blujepa), a first-in-class triazaacenaphthylene oral antibiotic from GSK, on 25 March 2025 for uncomplicated urinary tract infections (uUTIs) in women and girls aged 12+. GSK plans a US launch in the second half of 2025.

What excites me most?
🔹A long-awaited innovation – The first new oral antibiotic for uUTIs in nearly 30 years, introducing a novel bacterial Type II topoisomerase inhibitor chemotype.
🔹Broad-spectrum activity – Targets problematic pathogens like Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
🔹A model for public-private collaboration – Developed with support from BARDA and the Defense Threat Reduction Agency, highlighting the power of partnerships in tackling urgent health challenges.
🔹Bonus potential – Also in late-stage development for treating uncomplicated urogenital gonorrhoea.

With over half of women facing a uUTI in their lifetime and resistance eroding existing options, Blujepa could be a game-changer. How do you see this approval impacting patient care and the fight against AMR?

Structure of gepotidacin and a stylised a petri dish (created by Grok), highlighting its role as a new treatment for uncomplicated urinary tract infections.

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