The U.S. Food and Drug Administration has approved gepotidacin (Blujepa), a groundbreaking new oral antibiotic for the treatment of uncomplicated urinary tract infections (UTIs). This approval marks the first novel class of oral antibiotics for UTIs in more than 20 years, addressing a critical need in the face of rising antimicrobial resistance.
Developed by GSK, Blujepa is classified as a triazaacenaphthylene antibiotic and is approved for females aged 12 and older with uncomplicated UTIs. The medication is expected to be available to patients in the second half of 2025.
Addressing a Significant Public Health Burden
UTIs represent a substantial health burden, causing approximately 8 million emergency room visits and 100,000 hospitalizations annually in the United States. About half of all women will experience a UTI during their lifetime, with approximately 30% suffering from recurrent infections, according to GSK.
The increasing resistance of UTI-causing bacteria to existing antibiotics has complicated treatment options, making the approval of a novel antibiotic particularly significant. Dr. Tony Wood, Chief Scientific Officer at GSK, described Blujepa's approval as "a crucial milestone" in addressing this challenge.
"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," Wood stated.
Novel Mechanism of Action
Blujepa's innovative approach to fighting bacterial infections involves interfering with two enzymes that bacteria require for replication. This targeted mechanism of action may reduce the likelihood of bacteria developing resistance to the drug, according to Dr. Wood.
The development of Blujepa was supported in part by grants from the U.S. government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency, highlighting the public health significance of this new treatment option.
Clinical Efficacy and Safety Profile
In clinical trials involving more than 3,000 women and adolescent girls, Blujepa—administered as a twice-daily pill—demonstrated efficacy comparable to or better than nitrofurantoin, the current frontline antibiotic treatment for UTIs.
The most common side effects observed during clinical trials were diarrhea (affecting 16% of participants) and nausea (affecting 9% of participants). Most adverse events were classified as mild.
Expanding Treatment Options
While Blujepa represents the first new class of oral antibiotics for UTIs in decades, other antibiotics have recently received FDA approval for UTI treatment, though they belong to existing drug classes. These include Pivya, a type of penicillin approved in April 2024, and Orlynvah, approved in December 2023 for women with limited alternative treatment options.
The approval of Blujepa provides clinicians with an important new tool in the treatment arsenal for UTIs, particularly as concerns about antimicrobial resistance continue to grow. For patients experiencing symptoms such as painful or frequent urination, bloody urine, low abdominal cramps, or persistent urge to urinate, this new treatment option offers hope for more effective management of UTIs.
