The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. Gepotidacin, a pill, 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 women over the age of 12 for uncomplicated urinary tract infections or UTIs. About half of all women experience UTIs at some point in their lives, and about 30% have UTIs that return after treatment, drug maker GSK said.
Recurrent UTIs are a greater problem as the bacteria that cause them are resistant to the antibiotics available to treat them.
Blujepa is the first new type of oral antibiotic to treat UTIs for approval in more than 20 years. Its development was funded in part by grants from the US Government’s Biomedical Advanced Research and Development Agency and the Defense Threat Reduction Agency.
GSK’s Chief Science Officer Dr. Tony Wood said in a statement that Blujepa’s approval was a “significant milestone.”
“We are proud to develop our first Blujepa with a new class of oral antibiotics in nearly 30 years (without complications) and provide another option for patients given recurrent infections and increased resistance to existing treatments,” the statement said.
Other antibiotics have recently been approved for UTIs, but are compatible with existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplication UTIs, and Orlynvah was approved in December 2024 to treat uncomplication UTIs in women with limited antibiotic treatment options or no other antibiotic treatment options. Blujepa is known as a triazacenaphthylene antibiotic and is the first of its species.
UTIs are responsible for around 8 million emergency room visits and 100,000 hospitalizations in the United States each year, GSK said. They attack women more frequently than men.
Blujepa works by interfering with two enzymes that bacteria need to copy themselves. The mechanism of action is targeted, which could reduce the chance that bacteria will become resistant to it, Wood said Monday during a call with reporters.
Clinical trials with more than 3,000 women and teenage girls will take drugs twice a day – rather than nitrofurantoin, a frontline antibiotic currently used to treat UTIs.
Its main side effect was diarrhea, which affected 16% of patients in clinical trials and nausea affected 9% of participants. Most of these events were considered mild.
Symptoms of UTI include frequent, painful or burning urination, bloody urination, low stomach cramps, and the need to urinate even after going.
CNN Wire &2023 Cable News Network, Inc., Warner Bros Discovery Company. Unauthorized reproduction is prohibited.
