Orlynvah (Iterum Therapeutics), an oral fixed-dose combination of the thiopenem antibacterial prodrug sulopenem etzadroxil and the renal tubular transport inhibitor probenecid, has been approved by the FDA for treatment of uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in women who have limited or no alternative oral antibacterial treatment options. It is the first oral penem-containing product to be approved in the US.

The FDA has approved pivmecillinam (Pivya – Utility Therapeutics), an oral penicillin-class antibacterial drug, for treatment of uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus in adult females. Pivmecillinam was approved by the FDA in 2024 but only recently became available in the US. It has been used in Europe for over 40 years.

The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.