The Clinical Trials Behind GSK's Blujepa Approval – Trials Spotlight

Blujepa (gepotidacin), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in March 2025 for the treatment of female adults (≥40kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. The clinical trials, EAGLE-2 and EAGLE-3 were pivotal in that FDA approval. 

Both trials were Phase 3, randomized, double-blind, double-dummy, noninferiority trials comparing Blujepa with nitrofurantoin in the treatment of uncomplicated UTIs. A total of 3137 female patients were enrolled across the two trials (1531 in EAGLE-2 and 1606 in EAGLE-3). Randomization was stratified by age group (under 18, 18-50, older than 50) and history of recurrent uncomplicated UTIs.

Blujepa outperformed nitrofurantoin in both EAGLE-2 and EAGLE-3. EAGLE-2 saw a 4.3% treatment difference in favor of Blujepa. EAGLE-3 saw a 14.6% treatment difference in favor of Blujepa. Therapeutic success required the complete resolution of all baseline signs and symptoms of acute cystitis, no new signs or symptoms, and no need for additional antibiotic use for uncomplicated UTI. Microbiological success required the eradication of qualifying uropathogens present at baseline without additional antibiotic use for uncomplicated UTI.  

EAGLE-2 and EAGLE-3 Study Details

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) (EAGLE-2)

• Sponsor: GlaxoSmithKline
• Description: The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
• Intervention(s): Gepotidacin, placebo matching gepotidacin, nitrofurantoin, placebo matching nitrofurantoin
• Primary Outcome Measure(s): Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set); Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population.
• Time Frame(s): TOC visit (Days 9 to 16); TOC visit (Days 9 to 16).
• Study Details
• Source

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) (EAGLE-3)

• Sponsor: GlaxoSmithKline
• Description: The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
• Interventions: Gepotidacin, placebo matching gepotidacin, nitrofurantoin, placebo matching nitrofurantoin
• Primary Outcome Measure(s): Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set); Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population.
• Time Frame(s): TOC visit (Days 9 to 16); TOC visit (Days 9 to 16).
• Study Details
• Source

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