GSK plc (GSK) and Spero Therapeutics (SPRO) announced that the U.S. FDA has approved Utebzi (tebipenem pivoxil) as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, including pyelonephritisi, caused by certain susceptible pathogens in patients with limited or no alternative oral treatment options.
The decision follows a previous FDA Complete Response Letter (CRL) issued in June 2022, when the agency determined that additional data were needed to support the approval while the program was still under Spero Therapeutics' ownership. After GSK entered into an exclusive licensing agreement with Spero later that year, the companies resubmitted the NDA in December 2025, supported by new evidence from the successful Phase 3 PIVOT-PO trial.
The PIVOT-PO study demonstrated that Utebzi was non-inferior to intravenous therapy, meeting the primary efficacy endpoint in adults with cUTIs. The company said the oral formulation may help reduce reliance on hospital-based IV antibiotics, ease patient burden, and support outpatient management as antimicrobial resistance continues to rise.
More than 3 million cUTI cases occur annually in the U.S., with treatment failure affecting up to 34% of patients, often due to multidrug-resistant infections. These infections contribute to over $6 billion in healthcare costs each year, and reliance on IV carbapenems has historically increased hospital burden and reduced patient quality of life. Utebzi provides a potential outpatient alternative that may reduce dependence on hospital-based IV therapy.
Tony Wood, CSO at GSK, said the approval comes at a critical time as antibiotic resistance continues to rise, noting that an effective oral carbapenem "could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections."
Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health, called the approval a "major milestone," for patients who previously had few oral treatment alternatives.
SPRO has traded between $1.80 and $3.22 over the past year. The stock closed Wednesday's trading at $2.36, down 14.62%. During overnight trading the stock is at $2.65, up 25.59%.
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