Gepotidacin (Blujepa) — A New Antibiotic for Uncomplicated UTI
January 5, 2026 (Issue: 1745)
The FDA has approved gepotidacin (Blujepa – GSK), a
triazaacenaphthylene bacterial type II topoisomerase
inhibitor, for oral treatment of uncomplicated urinary
tract infections (uUTI) in female patients ≥12 years
old who weigh ≥40 kg....more
- FDA News Release. FDA approves two oral therapies to treat gonorrhea. December 12, 2025. Available at: https://bit.ly/3MwNOrA. Accessed December 15, 2025.
- PD Tamma et al. Infectious Diseases Society of America 2024 guidance on the treatment of antimicrobial-resistant gram-negative infections. Clin Infect Dis 2024 August 7 (epub). doi:10.1093/cid/ciad428
- K Gupta et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: a 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis 2011; 52:e103. doi:10.1093/cid/ciq257
- JY Kikuchi et al. Antibiotic prescribing patterns and guideline concordance for uncomplicated urinary tract infections among adult women in the US military health system. JAMA Netw Open 2022; 5:e2225730. doi:10.1001/jamanetworkopen.2022.25730
- Pivmecillinam (Pivya) – a new antibiotic for UTI. Med Lett Drugs Ther 2025 (in press).
- Sulopenem etzadroxil/probenecid (Orlynvah) for uncomplicated UTIs. Med Lett Drugs Ther 2025; 67:179.
- RR Watkins et al. Gepotidacin: a novel, oral, 'first-in-class' triazaacenaphthylene antibiotic for the treatment of uncomplicated urinary tract infections and urogenital gonorrhoea. J Antimicrob Chemother 2023; 78:1137. doi:10.1093/jac/dkad060
- MA Hackel et al. In vitro activity of gepotidacin against urinary tract infection isolates of Enterobacerales, Enterococcus faecalis, and Staphylococcus saprophyticus. Antimicrob Agents Chemother 2025; 69:e0029625. doi:10.1128/aac.00296-25
- F Wagenlehner et al. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. Lancet 2024; 403:741. doi:10.1016/s0140-6736(23)02196-7
- Inhibitors and inducers of CYP enzymes, P-glycoprotein, and other transporters. Med Lett Drugs Ther 2023 January 25 (epub). Available at: www.medicalletter.org/downloads/CYP_PGP_Tables.pdf.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. December 5, 2025. Reprinted with permission by First Databank, Inc. All rights reserved. ©2025. www.fdbhealth.com/ drug-pricing-policy.
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