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New Antibiotics For UTI Gets FDA Approval- First In 30 Years
Published Mar 26, 2025 3:43 AM EDT By Suneeta Sunny
Millions of women worldwide suffer from painful urinary tract infections (UTIs), and a growing number of these infections have become resistant to current antibiotics. But there's a hope still on the horizon: the U.S. Food and Drug Administration (FDA) has just approved a new antibiotic for UTIs, the first in nearly 30 years, offering hope for those battling antibiotic-resistant infections.
The new drug, Gepotidacin sold under brand name Blujepa, manufactured by GSK, has been approved for use in women and girls aged 12 and older with uncomplicated UTIs (uUTIs), the most common type of infection among women.
"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," Dr. Tony Wood, chief scientific officer of GSK, said in a statement.
A urinary tract infection is a bacterial infection typically caused by E.coli that can affect any part of the urinary system, including the kidneys, ureters, bladder, and urethra. Women are more prone to developing UTIs than men due to their anatomy. Common signs of a UTI include a frequent urge to urinate, pain or burning during urination, cloudy or strong-smelling urine, and lower abdominal pain.
According to GSK, more than half of all women will experience an uncomplicated UTI at least once in their lifetime, with about 30% facing recurrent episodes.
The new pills work by targeting two essential enzymes that E. coli bacteria depend on to replicate and survive, providing a fresh approach to treating UTIs. With its targeted mechanism of action, Blujepa may reduce the likelihood of bacteria developing resistance, Dr. Wood said.
The approval follows clinical trials involving over 3,000 women and teen girls, where Blujepa, a pill taken twice daily, demonstrated comparable or better efficacy than nitrofurantoin, the current frontline antibiotic for UTIs.
The most common side effects of Blujepa were mild stomach issues, with 16% of participants experiencing diarrhea and 9% nausea, while serious side effects were rare, affecting less than 1% of participants.
The organisms that cause vaginal infections do not cause UTI.
