FDA Approves First New Oral Antibiotic for UTIs in Over 20 Years

Blujepa, developed by GSK with US government funding, targets E. coli bacteria and aims to combat rising antibiotic resistance.

The FDA has approved Blujepa, a novel oral antibiotic for treating uncomplicated urinary tract infections (UTIs) in females aged 12 and older.
Blujepa is the first new oral antibiotic for UTIs to gain FDA approval in over two decades, marking a significant advancement in treatment options.
The drug's unique mechanism of action targets two enzymes essential for E. coli replication, potentially reducing bacterial resistance.
In clinical trials involving over 3,000 participants, Blujepa performed as well as or better than nitrofurantoin, a commonly prescribed UTI antibiotic, with mild side effects reported.
Developed by GSK with partial US government funding, Blujepa is expected to be available in the second half of 2025, with ongoing research exploring its use for other E. coli infections.