US FDA greenlights GSK’s Blujepa for UTIs in women and girls
The FDA approved GSK’s new antibiotic Blujepa for treating uncomplicated UTIs in females aged 12 and older after successful phase III trials demonstrated its efficacy compared to nitrofurantoin.
Published on March 29, 2025
On March 25, 2025, the US Food and Drug Administration approved GSK’s new antibiotic, Blujepa (gepotidacin), for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. The drug targets common bacteria such as E. coli — including antibiotic-resistant strains — and functions by interfering with enzymes critical for bacterial replication, a novel approach compared to standard treatments.
The approval was based on two landmark phase III trials, EAGLE-2 and EAGLE-3, which demonstrated Blujepa’s non-inferiority and, in some aspects, superiority to the established treatment nitrofurantoin. GSK plans to launch Blujepa in the US later in 2025 as part of its broader strategy to offset revenue losses from existing medicines and upcoming patent expirations.