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FDA has authorized gepotidacin for relieving uncomplicated urinary tract infections in pediatrics (≥12 years, ≥40 kg) and female adults (≥40 kg), introducing a new solution amid rising antibiotic resistance.
In a major advancement for women’s health and infectious disease treatment on 25 March 2025, the United States Food and Drug Administration (US-FDA) has officially granted approval to gepotidacin (a new oral antibiotic) for uncomplicated urinary tract infections (uUTIs) in female adults and paediatrics patients.
A Common Condition With Rising Resistance
In women, UTIs are one of the most common bacterial infections. They can markedly impact daily life, arousing discomfort, pain, and disruption to everyday activities. Over the years, many common bacteria responsible for UTIs—such as E. coli and Klebsiella pneumoniae—have developed resistance to existing antibiotics, leading to increasing rates of therapeutic failure and limited options for patients.
What Makes Gepotidacin Different?
Gepotidacin, a first-in-class triazaacenaphthylene antibiotic, interferes with bacterial DNA replication via a unique binding site, introducing a novel mechanism of action. It successfully inhibits two different type II topoisomerase enzymes in most pathogens, ensuring balanced inhibition. This dual inhibition offers activity against a broad range of uropathogens, even in strains resistant to current antibiotics.
Since gepotidacin requires specific mutations in both topoisomerase enzymes to markedly affect its efficacy, the potential for resistance development is minimized. This drug is designed to target specific bacteria commonly responsible for uUTIs, including:
It has also shown activity against Neisseria gonorrhoeae, the bacterium that causes gonorrhea, including strains that are resistant to current treatment options.
Backed by Strong Clinical Evidence
Regulatory authorization was granted on the basis of positive findings from the Phase III EAGLE-2 and EAGLE-3 trials, which showed that gepotidacin was non-inferior to nitrofurantoin—a widely used standard treatment for uUTIs—in female adults (≥40 kg) and pediatrics (≥12 years, ≥40 kg).
Gepotidacin's safety and tolerability profile observed in both trials was consistent with earlier studies. Among gepotidacin recipients, the most typical adverse events (AEs) were gastrointestinal in nature. Diarrhea was most commonly reported (16%), followed by nausea (9%). Among those who experienced gastrointestinal AEs in the gepotidacin arm, the majority were mild (69% Grade 1) or moderate (28% Grade 2) in severity. Severe gastrointestinal events (Grade 3) were rare, reported in just 3% of those with gastrointestinal AEs and in fewer than 1% of all participants. Each treatment arm (gepotidacin and nitrofurantoin) recorded one drug-related serious adverse event across the two studies.
A Step Forward in Antibiotic Innovation
The approval of gepotidacin not only addresses an urgent need in treating uUTIs but also represents progress in the global fight against antimicrobial resistance.
Drugs.com
FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections
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