Uncomplicated Urinary Tract Infection (UTI) Treatment Approved

Without a preventive vaccine available in the United States, an innovative treatment for uncomplicated urinary tract infections (uUTIs) has been approved.

New treatments are needed as the number of uUTIs caused by drug-resistant bacteria has increased, which can result in higher treatment failure rates.

GSK plc today announced that the U.S. Food and Drug Administration (FDA) has approved Blujepa, a first-in-class oral antibiotic with a novel mechanism of action that is GSK's infectious diseases portfolio.

Blujepa is approved for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kilograms) with uUTIs caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

GSK's Chief Scientific Officer, Tony Wood, commented in a press release on March 25, 2025, "The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. 

"We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades."

uUTIs are the most common infection in women, impacting up to 16 million women in the U.S. annually.

Over half of all women are affected by uUTI in their lifetime, with approximately 30% suffering from at least one recurrent episode, which can cause significant patient burden, including discomfort and restriction of daily activities.

Two other products have been approved for use.

Pivya™ (Pivmecillinam) is an extended-spectrum penicillin antibiotic. Pivya targets penicillin-binding protein-2 in the cell wall of gram-negative bacteria, and has been available in Europe.

ORLYNVAH™ is a U.S. FDA-approved novel oral penem antibiotic for treating uUTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women.

While an oral UTI vaccine is available in several countries in 2025, Uromune™ (MV140) is unavailable in the U.S.

However, international travelers can request a vaccine appointment using this Vax-Before-Travel link.