FDA Approves New Antibiotic for Treating UTIs in Women

TThe U.S. Food and Drug Administration (FDA) has approved Blujepa™ (gepotidacin), a novel antibiotic for the treatment of urinary tract infections (UTIs) in adult women. This approval represents a significant advancement in managing one of the most common bacterial infections affecting 16 million women annually in the U.S., particularly in the context of growing antibiotic resistance. Here’s what you need to know about this new treatment option.

Understanding UTIs and the Need for New Treatments
A urinary tract infection (UTI) occurs when bacteria invade the urinary system, which includes the bladder, kidneys, and urethra. Common symptoms include painful or burning urination, frequent urges to urinate, and lower abdominal discomfort.¹ Although UTIs are typically treated with antibiotics, the emergence of resistant bacterial strains has made standard therapies less effective.² As a result, the development of new treatment options such as Blujepa is essential to ensure continued effective care.

What is Blujepa and How Does It Work?
Blujepa is the trade name for a new antibacterial therapy called gepotidacin, a first-in-class oral antibiotic. Gepotidacin works by interfering with bacterial enzymes involved in DNA replication, thereby preventing bacterial growth. Blujepa has been approved to treat uncomplicated UTIs in pediatric female patients ages 12 and older who weigh at least 88 lbs., and in adult women. Blujepa is available as a 750 mg tablet and the recommended dosage is 1,500 mg (two 750 mg tablets) taken twice a day for five days.^3,4

Clinical Trial Evidence Supporting the Efficacy and Safety of Blujepa
The FDA’s approval of Blujepa was based on findings from two Phase 3 clinical trials. One trial directly compared gepotidacin to nitrofurantoin (Macrobid®), an established UTI treatment, in 541 adult women who were randomly assigned to receive either treatment. About 59% of women who took gepotidacin had full treatment success, compared to 44% in the nitrofurantoin group. When looking just at symptom relief, 68% of women on gepotidacin felt better, versus 63% on nitrofurantoin. In addition, 72% of women who took gepotidacin had the infection-causing bacteria cleared from their bodies, compared to only 57% in the nitrofurantoin group.^5–7

Blujepa was generally well tolerated. The most common side effects were gastrointestinal, with diarrhea (16%) and nausea (9%) being the most frequently reported. Most adverse events were mild to moderate in severity.^5–7

A Critical Step Forward in UTI Treatment
As antibiotic resistance continues to challenge public health, the approval of Blujepa provides healthcare professionals with a valuable new tool for managing complicated UTIs. Its effectiveness against resistant bacterial strains makes it a critical addition to the current treatment arsenal. The drug is expected to become available in the second half of 2025, likely at a higher cost than existing generic alternatives, with insurance coverage varying by provider.

References           

1. Urinary Tract Infection (UTI): Symptoms, Diagnosis & Treatment – Urology Care Foundation. https://www.urologyhealth.org/urology-a-z/u/urinary-tract-infections-in-adults.
2. Mareș, C. et al. Update on Urinary Tract Infection Antibiotic Resistance—A Retrospective Study in Females in Conjunction with Clinical Data. Life (Basel) 14, 106 (2024).
3. BLUJEPA (gepotidacin) tablets, for oral use. GlaxoSmithKline https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf (2025).
4. 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 | GSK. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/.
5. Hooton, T. M. et al. 2831. Efficacy and Safety of Gepotidacin for Uncomplicated Urinary Tract Infection: Pooled Subgroup Analyses of the EAGLE-2 and EAGLE-3 Randomized Phase 3 Trials. Open Forum Infectious Diseases 10, ofad500.2441 (2023).
6. Wagenlehner, F. et al. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. The Lancet 403, 741–755 (2024).
7. 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 | GSK. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/ (2025).