FDA Approves New Drug to Treat UTIs

The U.S. Food and Drug Administration (FDA) has approved a new type of antibiotic to treat urinary tract infections (UTIs). The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. It is approved to treat females 12 and older with uncomplicated UTIs. About half of all women will experience a UTI at some point in their lives, and about 30 percent will have a UTI that comes back after treatment.

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, said Tony Wood, BSc, PhD, chief scientific officer of GSK. 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 percent of patients in the clinical trial, and nausea, which affected nine percent of participants. Most of these events were considered mild.

“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,” said Dr. Wood.