GSK-Spero’s oral antibiotic Utebzi (tebipenem pivoxil hydrobromide) cleared a U.S. FDA approval gate for complicated urinary tract infections (cUTI), including pyelonephritis. The agency approved the drug after Spero’s earlier complete response letter, using phase III data showing noninferiority to intravenous imipenem-cilastatin. The approval follows a regulatory pivot that came four years after the initial CRL. Utebzi is expected to be available by the end of 2026. Under the 2022 $600 million license arrangement, GSK received global rights with exceptions for Japan and certain Asian markets retained from original developer Meiji Seika Pharma, positioning the company to expand oral options in an area where IV-only regimens remain common.