The US Food and Drug Administration (FDA) has approved a new antibiotic, gepotidacin, under the brand name Blujepa, to treat uncomplicated urinary tract infections (UTIs) in females 12 and older. The pill is expected to be available in the second half of 2025.
About half of all women will experience a UTI at some point in their lives, with about 30% experiencing recurrent infections that do not respond to treatment. This has become a significant problem as bacteria resistant to current antibiotics have grown more prevalent.
Blujepa is the first new oral antibiotic for UTIs to gain FDA approval in over 20 years. Developed by GSK, it belongs to a new class of triazaacenaphthylene antibiotics that target specific bacterial enzymes. This mechanism may reduce the risk of bacteria becoming resistant to the drug.
According to GSK, UTIs cause approximately 8 million emergency room visits and 100,000 hospitalizations in the US each year. Women are more likely to be affected by UTIs than men.
In clinical trials involving over 3,000 women and teen girls, Blujepa demonstrated comparable efficacy to the current frontline antibiotic, nitrofurantoin. Common side effects of the drug were diarrhea (16% of patients) and nausea (9% of participants), with most being mild.
Source: https://edition.cnn.com/2025/03/25/health/uti-antibiotic-fda-gepotidacin-blujepa/index.html