The First New Oral UTI Antibiotic in 30 Years

For millions of women, urinary tract infections (UTIs) are more than just a minor health nuisance – they are a recurring, disruptive burden. With rising antibiotic resistance making standard treatments less effective, finding new solutions has become increasingly urgent.

Now, after nearly three decades without a novel oral antibiotic for UTIs, GlaxoSmithKline Pharmaceuticals' (GSK) newly approved drug, Blujepa (gepotidacin), offers hope.

The need for a new UTI treatment

UTIs are among the most common bacterial infections, particularly in women. More than half of all women will experience a UTI at some point in their lives, and for many, the problem doesn’t stop at a single episode. Approximately 30% of women suffer from recurrent UTIs, dealing with multiple infections that can cause discomfort and disruption to daily life. In the US alone, UTIs impact up to 16 million women annually, leading to millions of doctor visits and antibiotic prescriptions each year.

“For many, uncomplicated UTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems,” said Dr. Thomas Hooton, a professor of clinical medicine at the University of Miami School of Medicine.

For those affected, UTIs are more than just a temporary inconvenience, they can have a serious impact on daily life. Symptoms such as painful urination, frequent urgency and abdominal discomfort can interfere with work, sleep and overall well-being. The emotional toll can also be significant, particularly for those who experience frequent recurrences. With limited treatment options and resistance on the rise, there is an urgent need for new antibiotics that can effectively combat UTIs while reducing the risk of resistance development.

Now, a newly approved antibiotic, Blujepa, aims to address these challenges by offering an alternative treatment option with a novel approach to combating bacterial resistance.

What makes Blujepa different?

Blujepa is the first oral antibiotic in a new class to be introduced in nearly 30 years. The drug has been approved by the US Food and Drug Administration (FDA) for the treatment of uncomplicated UTIs in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg). Blujepa works differently from many currently available antibiotics. It is a triazaacenaphthylene antibiotic that targets bacterial DNA replication by inhibiting two enzymes: DNA gyrase and topoisomerase IV. These enzymes are essential for bacterial growth and survival. Because Blujepa acts on both simultaneously, bacteria would need to develop mutations in both enzymes at the same time to reduce the drug’s effectiveness. This dual-target approach is expected to slow the development of resistance compared to antibiotics that act on a single enzyme.

The approval of Blujepa was based on two Phase III clinical trials, EAGLE-2 and EAGLE-3, which compared its effectiveness to nitrofurantoin, a commonly prescribed antibiotic for uncomplicated UTIs. In EAGLE-3, Blujepa demonstrated higher therapeutic success, with 58.5% of patients achieving resolution of infection compared to 43.6% of those treated with nitrofurantoin. In EAGLE-2, Blujepa was shown to be non-inferior to nitrofurantoin.

The drug was also generally tolerated well in clinical trials. The most reported side effects were gastrointestinal, with diarrhea (16%) and nausea (9%) being the most frequent, and the majority of these were mild to moderate in severity. Serious adverse events were rare and occurred at similar rates between Blujepa and nitrofurantoin.

What comes next?

With FDA approval secured, Blujepa is now positioned to become a new treatment option for uncomplicated UTIs. However, while the regulatory milestone is large, patients and healthcare providers will have to wait before the drug becomes widely available. GSK plans to launch Blujepa commercially in the US in the second half of 2025, allowing time for production and distribution to scale up.

By offering a new mechanism of action, the newly approved drug could help address the challenge of antibiotic resistance, particularly for patients who have experienced recurrent infections or treatment failures with existing antibiotics. If it performs as expected in real-world use, it may become a preferred option for uncomplicated UTIs.

Beyond UTIs, Blujepa has also been studied for its potential to treat other infections. It has undergone Phase III trials for the treatment of uncomplicated gonorrhea, another bacterial infection with increasing resistance to standard antibiotics.

“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” said Dr. Tony Wood, Chief Scientific Officer, GSK.

This article is a rework of a press release issued by GlaxoSmithKline Pharmaceuticals. Material has been edited for length and content.