FDA Approves First Oral UTI Antibiotic in Decades for Women
Gepotidacin offers a new treatment path for uncomplicated UTIs, targeting common resistant bacteria in girls and women
Topline:
The FDA has approved gepotidacin (Blujepa), a first-in-class oral antibiotic for uncomplicated urinary tract infections in women and girls aged 12 and older, offering a novel mechanism of action and a promising alternative to traditional therapies like nitrofurantoin.
Study Details
Gepotidacin, developed by GSK, is a pioneering antibiotic that inhibits bacterial DNA replication using a unique mechanism. This approval stems from two large-scale phase III trials—EAGLE-2 and EAGLE-3—which evaluated its efficacy in over 3,000 female participants aged 12 and above with uncomplicated UTIs.
These trials come at a crucial time, as over 16 million U.S. women experience uncomplicated UTIs annually, with 30% facing recurrent infections. The rise in antibiotic resistance has made new treatment options essential.
Methodology
In the randomized, double-blind studies, participants were assigned either gepotidacin or nitrofurantoin. The primary endpoint was therapeutic success, measured as symptom resolution and bacterial clearance.
EAGLE-2: 50.6% (gepotidacin) vs 47% (nitrofurantoin)
EAGLE-3: 58.5% (gepotidacin) vs 43.6% (nitrofurantoin)
Gepotidacin met the noninferiority threshold in both trials and outperformed nitrofurantoin in EAGLE-3.
Key Findings
Efficacy: Gepotidacin was shown to be effective against Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Staphylococcus saprophyticus, and Enterococcus faecalis.
Adverse Events: Mild to moderate gastrointestinal side effects were most common (diarrhea 16%, nausea 9%).
Dosing: For patients weighing at least 40 kg (88 lbs), the drug will be administered orally.
Gepotidacin stands out due to its dual inhibition of bacterial Type II topoisomerases, a mechanism distinct from other antibiotics, helping tackle drug resistance.
Implications for Practice
For patients:
Women and girls with recurrent UTIs may soon have access to a new oral treatment that can potentially reduce reliance on older antibiotics, many of which are becoming less effective due to resistance.
For healthcare providers:
Gepotidacin introduces a novel class to the outpatient UTI treatment toolkit, especially for patients with resistance to conventional antibiotics. Its oral formulation and broad pathogen coverage make it ideal for primary care and telemedicine use.
The drug is expected to become available in the second half of 2025.