On March 25, 2025, the U.S. Food and Drug Administration (FDA) approved Blujepa (gepotidacin), a novel oral antibiotic developed by GSK, for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 years and older. This marks the first introduction of a new class of oral antibiotics for uUTIs in nearly three decades.

uUTIs are among the most common infections affecting women, with over half experiencing at least one episode in their lifetime. Approximately 30% of these women suffer from recurrent infections, leading to significant discomfort and disruption of daily activities. The primary causative agent is Escherichia coli (E. coli), though other bacteria such as Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis are also implicated.

Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action. It targets two bacterial enzymes, DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication. By inhibiting these enzymes, Blujepa disrupts bacterial DNA replication, leading to bacterial cell death. This dual-target approach may reduce the likelihood of resistance development compared to existing antibiotics.

The FDA's approval was based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. These trials demonstrated that Blujepa was non-inferior to nitrofurantoin, a standard treatment for uUTIs, and in one trial, it showed statistical superiority. In EAGLE-2, therapeutic success was achieved in 50.6% of patients treated with Blujepa compared to 47.0% with nitrofurantoin. In EAGLE-3, Blujepa achieved therapeutic success in 58.5% of patients versus 43.6% for nitrofurantoin.

The safety profile of Blujepa was consistent with previous trials. The most commonly reported adverse events were gastrointestinal, including diarrhea (16% of participants) and nausea (9%). Most gastrointestinal adverse events were mild to moderate in severity.

GSK plans to launch Blujepa in the U.S. in the second half of 2025. The company is banking on new drugs in its infectious diseases portfolio, including Blujepa, to offset revenue losses from patent expirations of its leading medicines. GSK has stated that it expects Blujepa, along with two other medicines in development, to generate peak year sales of more than £2 billion ($2.59 billion).

The development of Blujepa was partially funded by the U.S. government's Biomedical Advanced Research and Development Authority (BARDA) and the Defense Threat Reduction Agency (DTRA). This collaboration aimed to support the development of antibiotics to combat antibiotic resistance and bioterrorism.

The approval of Blujepa addresses a significant unmet medical need, offering a new treatment option for the millions of women affected by uUTIs annually. Its novel mechanism of action provides an alternative in the face of rising antibiotic resistance, potentially reducing treatment failures and improving patient outcomes.

The introduction of Blujepa represents a significant advancement in the treatment of uUTIs, providing healthcare professionals with a new tool to combat these common infections. As antibiotic resistance continues to pose a global health challenge, the approval of Blujepa underscores the importance of ongoing research and development in the field of infectious diseases.