The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025.
Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said.
Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them.
Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government’s Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa’s approval is “a crucial milestone.”
“We are proud to have developed Blujepa, the first in a new class of oral antibiotics for (uncomplicated UTIs) in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” the statement said.
Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what’s known as a triazaacenaphthylene antibiotic and it’s the first of its kind.
UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men.
Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters.
In clinical trials with more than 3,000 women and teen girls, the drug – a pill taken twice daily – performed as well as or better than nitrofurantoin, the frontline antibiotic that is currently used to treat UTIs.
Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild.
Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
