FDA Approves First New Oral Antibiotic for UTIs in Nearly 30 Years

Blujepa, developed by GSK, offers a novel treatment for uncomplicated UTIs, addressing rising antibiotic resistance and recurrent infections.

Blujepa is the first oral antibiotic approved for uncomplicated urinary tract infections (uUTIs) since 1996, targeting women and girls aged 12 and older.
The drug demonstrated non-inferiority to nitrofurantoin in Phase III trials, treating 50% to 58% of infections compared to 43% to 47% for the older antibiotic.
Blujepa introduces a new mechanism of action by inhibiting bacterial DNA replication, offering a fresh approach to combat resistant bacteria.
Development of Blujepa was partially funded by U.S. federal agencies, emphasizing the role of public investment in advancing medical innovation.
GSK plans to launch Blujepa commercially in the U.S. during the second half of 2025, providing new hope for the 16 million women affected by UTIs annually.