A New Era in the Treatment of UTIs

Urinary tract infections (UTIs) are one of the most common bacterial infections in the United States, impacting up to 16 million women each year.1 Traditionally, uncomplicated UTIs (uUTIs) are treated empirically with antibiotics such as nitrofurantoin, fosfomycin, or trimethoprim-sulfamethoxazole.2  However, these treatments have faced significant challenges in recent years due to the rapid progression of antimicrobial resistance and a lack of development of new antibiotics. The World Health Organization (WHO) has identified a downward trend in new antibiotic development, approval, and innovation within the last ten years, underscoring the urgent need for new antimicrobial therapies.3

Gepotidacin is a first-in-class oral triazaacenaphthylene antibiotic that offers a promising treatment for uUTIs, including those resistant to multiple drug classes. Gepotidacin blocks bacterial DNA replication by inhibiting two essential bacterial enzymes: topoisomerase II (DNA gyrase) and topoisomerase IV.4 Unlike traditional fluoroquinolones, gepotidacin binds to a unique site on these enzymes, allowing it to remain effective against fluoroquinolone-resistant strains and reducing the risk of cross-resistance.5

On March 25, 2025, the U.S. Food and Drug Administration (FDA) approved BLUJEPA (gepotidacin) for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms with uUTIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.4 This marks the first FDA-approved oral antibiotic from a new class for the treatment of uUTIs in nearly 30 years.1 HardyDisk™ AST Gepotidacin received FDA clearance shortly after the drug’s approval for antimicrobial susceptibility testing (AST) of this novel agent.

Why HardyDisk™ AST Matters

The introduction of gepotidacin provides an alternative treatment option for treating uUTIs. Its approval encourages the development of new antibiotic classes and underscores the importance of ongoing stewardship efforts. As with all antimicrobial agents, gepotidacin's long-term effectiveness will rely on accurate AST and responsible prescribing. HardyDisk™ AST Gepotidacin will allow clinicians to make confident and informed decisions about antimicrobial treatment, thus improving patient outcomes and combating the development of antimicrobial resistance.

HardyDisk_AST-1

Cat. no. Z9491

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Sources:

  1. GSK plc. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. Press release; March 25, 2025. Accessed October 17, 2025. GSK

  2. Kaye KS, Gupta V, Mulgirigama A, Joshi AV, Scangarella-Oman N, Buechel K, et al. Antimicrobial resistance trends in urine Escherichia coli isolates from adult and adolescent females in the United States, 2011–2019: rising ESBL strains and impact on patient management. Clin Infect Dis. 2021;73(11):1992-1999. Accessed October 17, 2025. PubMed Central

  3. World Health Organization. Lack of innovation set to undermine antibiotic performance and health gains. News release; June 22, 2022. Accessed October 17, 2025. World Health Organization

  4. U.S. Food and Drug Administration. BLUJEPA (gepotidacin) tablets, for oral use — Prescribing Information. Initial U.S. Approval: 2025; revised March 2025. Accessed October 17, 2025. FDA Access Data

  5. Watkins RR, Thapaliya D, Lemonovich TL, Bonomo RA. 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(5):1137-1142. doi:10.1093/jac/dkad060. Accessed October 17, 2025. academic.oup.com

Meet the authors

Belle Quaresma

R&D MICROBIOLOGIST II at HARDY DIAGNOSTICS

Belle Quaresma

Belle joined the team in October 2024, where she contributes to the development and evaluation of innovative microbiological testing solutions. With a passionate interest in microbial detection and diagnostics, Belle’s work supports Hardy Diagnostics’ mission to deliver the finest products for the detection of microorganisms.

Lauren_Hamilton

PERFORMANCE STUDIES SUPERVISOR at HARDY DIAGNOSTICS

Lauren Hamilton, MS Microbiology & Cell Science

Lauren leads a team dedicated to achieving FDA 510(k) clearance for Class II microbiology in vitro diagnostics devices, AOAC certifications, MicroVal certifications, and more. She earned her BS in Microbiology from Cal Poly San Luis Obispo while conducting epigenetics research and her MS in Microbiology and Cell Science at the University of Florida. An active member of the American Society for Microbiology (ASM), AOAC International, and the International Association for Food Protection (IAFP), Lauren contributes to these organizations through publications, presentations, and committee service. She serves on the AOAC INTERNATIONAL Safety and Security Committee. Additionally, Lauren leads the Hardy Diagnostics Community Action Committee, coordinating the company’s community involvement. In her free time, Lauren enjoys practicing aerial arts, experimenting with new recipes, and volunteering in the community.