GSK has reported positive results from the PIVOT-PO Phase III trial for tebipenem HBr, which is a major advancement for the treatment of complicated urinary tract infections (cUTIs). The oral antibiotic proved to be non-inferior to intravenous (IV) imipenem-cilastatin, the standard of care for hospitalised adult patients with cUTIs, according to the trial, which was terminated early because of its proven effectiveness.
The safety profile of tebipenem HBr was comparable to that of imipenem-cilastatin and other carbapenems, with mild to moderate diarrhoea and headache being the most frequent adverse events. The worldwide, randomised, double-blind trial included 1,690 patients and reported that oral tebipenem HBr had a success rate of 58.5% compared to 60.2% for the IV treatment.
Complicated UTIs can have serious consequences for patients, including organ failure and sepsis, and oral options for drug-resistant infections are limited. These ground-breaking data show for the first time that cUTIs, including pyelonephritis, can be treated with an oral carbapenem antibiotic as effectively as with an intravenous one. We have a long-standing commitment to delivering novel anti-infectives and are delighted to offer the potential of tebipenem HBr as an effective oral alternative that could be taken at home
Tony Wood
The overall response at the test-of-cure visit, which was a composite of clinical cure and microbiological eradication, was the trial’s main outcome. Both groups had high clinical cure rates: 95.2% for imipenem-cilastatin and 93.5% for tebipenem HBr. The corresponding microbiological response rates were 60.3% and 61.3%.
Tebipenem HBr has the potential to address the growing problem of drug-resistant bacteria, as evidenced by the fact that the response rates in patients with infections caused by antimicrobial-resistant Enterobacterales were comparable to the general population.
In the fourth quarter of 2025, GSK intends to file a regulatory application for tebipenem HBr. If approved, it would be the first oral carbapenem antibiotic available for patients with cUTIs, offering a more convenient and potentially cost-effective treatment option compared to IV therapy. Additionally, this might lessen hospital stays and the strain on healthcare systems.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
