BLUJEPA(gepotidacin): FDA Approves New Treatment for Uncomplicated Urinary Tract Infections on March 25, 2025

BLUJEPA(gepotidacin): FDA Approves New Treatment for Uncomplicated Urinary Tract Infections on March 25, 2025
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What is it prescribed for?

BLUJEPA is prescribed for the treatment of female adults and pediatric patients 12 years of age and older (weighing at least 40 kilograms, or 88 pounds) with uncomplicated urinary tract infections (uUTIs) caused by certain bacteria, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis​.

What is the name of the drug and what does it do?

The brand name is BLUJEPA (pronounced "blu-JEP-ah"), and the generic name is gepotidacin. BLUJEPA treats bladder infections, specifically uncomplicated urinary tract infections, by targeting the bacteria causing the infection​.

How does it work?

BLUJEPA is a type of antibiotic that works by blocking bacterial enzymes called topoisomerase II (DNA gyrase) and topoisomerase IV. These enzymes are necessary for bacterial DNA to replicate. By stopping them, BLUJEPA kills the bacteria and helps clear the infection​.

What did the research discover?

In clinical trials, BLUJEPA was found to be just as effective as nitrofurantoin, a standard treatment for bladder infections:

  • In two major studies, BLUJEPA showed a composite response rate (meaning both clinical cure and bacterial eradication) that was similar or slightly better than nitrofurantoin​.
  • For example, in one trial, 58.9% of patients treated with BLUJEPA achieved full resolution compared to 44.0% for nitrofurantoin​.
  • Patients treated with BLUJEPA also had good outcomes across different bacteria types, especially for Escherichia coli, the most common cause of urinary tract infections​.

What are some of the side effects?

Common side effects (occurring in 1% or more of patients):

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Flatulence (gas)
  • Headache
  • Soft stools
  • Dizziness
  • Vomiting
  • Vulvovaginal candidiasis (yeast infection)​

What are the dosage recommendations and how is it prescribed?

BLUJEPA is taken by mouth:

  • The recommended dosage is 1,500 mg (two 750 mg tablets) taken twice daily (about 12 hours apart) for 5 days​.
  • It should be taken after a meal to help prevent stomach upset​.
  • Patients should not double doses if a dose is missed and should complete the full course to ensure effectiveness​.

Source:

GlaxoSmithKline. BLUJEPA (gepotidacin) tablets. Prescribing Information. 2025. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf

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