FDA

Novel antibacterial approved for uncomplicated UTI in females

March 27, 2025

Brand name: Blujepa

Generic name: gepotidacin

Manufacturer: GSK

Approval date: March 25, 2025

FDA approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

Gepotidican is a triazaacenaphthylene antibacterial that inhibits Type II topoisomerases including bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, thereby inhibiting DNA replication.

Efficacy

Approval was based on data from two phase 3 trials, EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144), which compared the efficacy and safety of gepotidacin vs. nitrofurantoin in female patients with uUTI.

Study participants were randomly assigned to receive gepotidacin 1,500 mg bid or nitrofurantoin 100 mg bid for 5 days. The primary endpoint for both trials was the combined clinical and microbiological response (therapeutic success) at the test-of-cure visit in participants with nitrofurantoin-susceptible uropathogens.

Gepotidacin was found to be noninferior to nitrofurantoin in both trials.

In EAGLE-2, rates of therapeutic success were:

• gepotidacin: 51.8%
• nitrofurantoin: 47%

In EAGLE-3, rates of therapeutic success were:

• gepotidacin: 58.9%
• nitrofurantoin: 44%

Safety

The most common adverse reactions reported with gepotidacin (≥1% of patients) were diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.

Recommended dose

The recommended dosage of gepotidacin is 1,500mg (two 750-mg tablets) PO bid for 5 days. Administration after a meal is recommended to help reduce GI intolerance.

Sources:

GSK. Blujepa (gepotidacin) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf Revised March 2025. Accessed March 26, 2025.

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. [News release]. 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/