FDA Approves Blujepa: First New UTI Antibiotic in 30 Years Targets Drug-Resistant Bacteria
March 25, 2025
Dr. Sovrin Shah noted that over 2.8 million antimicrobial-resistant infections occur annually in the U.S., with a significant percentage of bacteria showing resistance to commonly used antibiotics.
Blujepa works by disrupting two enzymes essential for bacterial replication, which may help reduce the risk of developing bacterial resistance.
In clinical trials involving 3,000 participants, Blujepa effectively treated 50% to 58% of infections, outperforming nitrofurantoin, which treated 43% to 47%.
Common symptoms of UTIs include painful or burning urination, blood in urine, and persistent urges to urinate, which can lead to serious complications if untreated.
The FDA has approved Gepotidacin, branded as Blujepa, marking the first new antibiotic for urinary tract infections (UTIs) in nearly three decades.
UTIs, primarily caused by E. coli bacteria, can affect various parts of the urinary system, with women being more susceptible due to anatomical differences.
A study revealed that more than 92% of UTI-causing bacteria were resistant to at least one drug, with around 80% resistant to two or more drugs.
The development of Blujepa received partial funding from federal grants from the U.S. government's Center for the Biomedical Advanced Research and Development Authority.
GSK plans to launch Blujepa in the second half of 2025 as part of its strategy to pursue five expected approvals in 2025, aiming for sales exceeding 40 billion pounds sterling by 2031.
The approval was supported by positive results from phase III EAGLE-2 and EAGLE-3 trials, demonstrating Blujepa's non-inferiority to nitrofurantoin, a leading treatment option.
Blujepa is effective against UTIs caused by various microorganisms, including E. coli and Klebsiella pneumoniae, which are commonly responsible for these infections.
The most common side effects of Blujepa are mild, with 16% of participants experiencing diarrhea and 9% experiencing nausea.
Summary based on 10 sources
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Sources

Time • Mar 25, 2025
There's a New Pill to Treat UTIs
NBC News • Mar 25, 2025
FDA approves first new antibiotic for UTIs in nearly 30 years