Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide, branded as Utebzi, has received US FDA approval for complicated urinary tract infections (cUTI), including pyelonephritis. The agency’s decision comes about four years after a prior complete response letter. The approval is backed by Phase III data showing noninferiority versus intravenous imipenem-cilastatin, giving the drug an oral option for a setting where clinicians often rely on IV therapy. Spero’s partner GSK previously secured global rights under a $600 million license deal signed in 2022 (excluding Japan and certain Asian markets tied to original development). Utebzi is expected to be available by the end of 2026. The move adds to momentum for oral alternatives to injectable antibiotics, particularly in hospital-adjacent care pathways where faster switching and outpatient treatment are key operational goals.