FDA Approves Gepotidacin (Blujepa): First New Oral Antibiotic Class for UTIs in Decades
Key takeaways:
Gepotidacin (Blujepa) is a new oral antibiotic. It’s FDA approved for uncomplicated urinary tract infections (UTIs) in women and girls ages 12 and older. It’s the first antibiotic in its class.
Gepotidacin is effective against certain drug-resistent UTI bacteria. It offers a new option when standard antibiotics, such as nitrofurantoin (Macrobid, Macrodantin) and sulfamethoxazole / trimethoprim (Bactrim), may not work.
Gepotidacin is expected to launch in the second half of 2025. Check back with GoodRx for ways to save on your prescription once it’s available.
Table of contents
Urinary tract infections (UTIs) are among the most common bacterial infections, especially in women. Research says that over half of women experience at least one UTI in their lifetime. And about 30% will have a UTI that comes back. Most UTI cases occur in healthy people with no underlying urinary tract issues. These infections are considered uncomplicated.
Antibiotics remain the standard treatment for uncomplicated UTIs. But rising antibiotic resistance has made it increasingly difficult to treat them effectively. Despite these challenges, no new oral antibiotic class has been approved for this use in decades — until now. With the FDA’s approval of gepotidacin (Blujepa), healthcare professionals will have a new option to prescribe for UTI treatment.
Why is a new antibiotic for UTIs important?
Antibiotic resistance is one of the biggest challenges in UTI treatment today. Many first-choice UTI antibiotics, such as nitrofurantoin (Macrobid, Macrodantin) and sulfamethoxazole / trimethoprim (Bactrim), are becoming less effective against certain bacteria. This growing resistance can lead to:
More recurrent and harder-to-treat infections
Higher risk of complications, such as kidney infections
Fewer effective treatment options
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That’s why the approval of gepotidacin — a first-in-class antibiotic that works differently from current treatments — is such a significant milestone.
What is gepotidacin?
Gepotidacin is a new oral antibiotic. It’s approved to treat uncomplicated UTIs in women and girls ages 12 and older who weigh at least 40 kg (88 lbs). It comes as an oral tablet — you’ll take 2 tablets twice daily after a meal for 5 days.
Gepotidacin is effective against common UTI-causing bacteria, including some that are resistant to current treatments. Your prescriber may recommend gepotidacin if they determine it’s a suitable option, especially if you have risk factors for antibiotic resistance or past treatment failure. However, gepotidacin isn’t recommended for certain people, including those who:
Have a history of QT prolongation or take medications that cause QT prolongation
Are taking certain medications that strongly interact with gepotidacin, such as ketoconazole or carbamazepine
Have severe liver or kidney disease
Make sure that your healthcare team has your health history and current medication list. This can help them ensure that gepotidacin is safe for you to take.
How does gepotidacin work?
Gepotidacin is the first antibiotic in its class, working differently than existing UTI treatments. It works by blocking two essential enzymes that bacteria need to multiply and survive. By targeting two enzymes, gepotidacin can:
Make it more difficult for bacteria to develop resistance
Remain effective against certain bacteria that no longer respond to other antibiotics
Speed up UTI recovery: Taking antibiotics as directed is your best bet to treat a UTI. But some over-the-counter (OTC) medications and at-home remedies may relieve your symptoms faster.
Antibiotic treatment for UTIs: Learn which antibiotics are most effective for UTIs and how healthcare professionals decide which one to prescribe.
Prevent future UTIs: Get tips from our medical team to help lower your chances of developing a UTI. Plus, find out which conditions may contribute to recurrent UTIs.
How well does gepotidacin work for UTIs?
The EAGLE-2 and EAGLE-3 clinical trials directly compared gepotidacin to nitrofurantoin to see how well it could clear UTIs. Both trials found that gepotidacin works as well as nitrofurantoin. But during the EAGLE-3 trial, researchers found it worked better.
Gepotidacin also worked well for people who are more likely to experience treatment failure. This includes women who:
Are over 50 years old
Have a history of UTI recurrence
Have a UTI caused by certain antibiotic-resistant bacteria
What side effects are possible with gepotidacin?
Like all antibiotics, gepotidacin has potential side effects. The most commonly reported side effects in clinical trials include:
Diarrhea
Nausea
Gas
Headache
Dizziness
Vomiting
Abdominal pain
People taking gepotidacin have reported experiencing more serious side effects, though this has been rare. Examples of such side effects include difficulty speaking (dysarthria) and Clostridioides difficile infection.
Fluoroquinolone antibiotics, which have some similarities to gepotidacin, are known to have a risk of serious toxicities. But gepotidacin hasn’t been linked to the same side effects, such as tendon rupture.
How does gepotidacin compare to other antibiotics?
Gepotidacin offers several potential advantages over existing antibiotics for treating uncomplicated UTIs. This is especially the case for people who are at risk of treatment failure or resistance.
For starters, gepotidacin is part of an entirely new class of antibiotics. Its approval marks the first new oral antibiotic class for uncomplicated UTIs in decades. Because it works differently, it may be harder for bacteria to adapt and develop resistance against it. In contrast, some older UTI antibiotics are now showing increasing levels of resistance. This can limit how well they work in certain cases.
Based on study results, gepotidacin works as well as or better than nitrofurantoin, especially for women who are older or have recurrent UTIs.
Gepotidacin isn’t expected to replace all existing treatments. But it adds a much-needed option to the current lineup — especially in an era where antibiotic resistance is making UTI treatment more challenging.
When will gepotidacin be available?
The manufacturer expects to launch gepotidacin in the second half of 2025. Once it’s available, check back with GoodRx for ways to save on your prescription. This may include GoodRx discounts, manufacturer copay cards, and patient assistance programs.
The bottom line
Gepotidacin (Blujepa) is the first new oral antibiotic for uncomplicated urinary tract infections (UTIs) in decades. It arrives at a time when antibiotic resistance is making UTIs harder to treat.
Gepotidacin is approved for uncomplicated UTIs in women and girls ages 12 and older. It can offer an alternative to traditional treatments such as nitrofurantoin (Macrobid, Macrodantin), especially in cases where they may not work due to resistance.
Gepotidacin is expected to launch in the second half of 2025. As with any medication, talk to your healthcare team about whether gepotidacin is right for you.
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References
Al-Badr, A., et al. (2013). Recurrent urinary tract infections management in women: A review. Sultan Qaboos University Medical Journal.
Aggarwal, N., et al. (2025). Recurrent urinary tract infections. StatPearls.
Belyayeva, M., et al. (2024). Acute pyelonephritis. StatPearls.
Dunne, M.W., et al. (2022). A multicenter analysis of trends in resistance in urinary Enterobacterales isolates from ambulatory patients in the United States: 2011–2020. BMC Infectious Diseases.
Fishman, C., et al. (2022). Novel bacterial topoisomerase inhibitor gepotidacin demonstrates absence of fluoroquinolone-like arthropathy in juvenile rats. Antimicrobial Agents and Chemotherapy.
Hooten, T.M., et al. (2023). 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.
Mares, C., et al. (2024). Update on urinary tract infection antibiotic resistance—A retrospective study in females in conjunction with clinical data. Life.
Oviatt, A.A., et al. (2024). Interactions between gepotidacin and Escherichia coli gyrase and topoisomerase IV: Genetic and biochemical evidence for well-balanced dual-targeting. ACS Infectious Diseases.
U.S. Food and Drug Administration. (2025). Blujepa [package insert].
Wagenlehner, F., et al. (2024). 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.
Watkins, R.R., et al. (2023). Gepotidacin: a novel, oral, ‘first-in-class’ triazaacenaphthylene antibiotic for the treatment of uncomplicated urinary tract infections and urogenital gonorrhoea | Journal of Antimicrobial Chemotherapy. Journal of Antimicrobial Chemotherapy.
