Posted by Michael Wonder on 20 Dec 2025
Spero announces NDA resubmission of tebipenem hydrobromide by GSK to the FDA for the treatment of complicated urinary tract infections, including pyelonephritis
19 December 2025 - Spero Therapeutics today announced that its development partner, GSK, filed a new drug application resubmission to the US FDA for tebipenem hydrobromide, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections, including pyelonephritis.
The new drug application resubmission is supported by results from the successful Phase 3 PIVOT-PO trial.
