SPRO Spero Therapeutics

Spero/GSK: Utebzi (tebipenem pivoxil) FDA-approved for cUTIs

FDA approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic in the US, for adults with complicated urinary tract infections who have limited or no alternative oral options. The approval is based on the PIVOT-PO Phase 3 trial showing non-inferiority to IV imipenem-cilastatin. GSK holds exclusive global rights (excluding select Asian territories) and plans US launch by end of 2026.

Spero Therapeutics, Inc. · FDA approves Utebzi (tebipenem pivoxil)

FDA lists Utebzi (tebipenem pivoxil) as novel drug approval #22 of 2026 on 2026-06-17: To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options

Spero: tebipenem HBr NDA PDUFA set for June 18, 2026

FDA set the PDUFA date for the tebipenem HBr NDA to June 18, 2026. The NDA was submitted by GSK in December 2025 and is supported by the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025.

Spero: GSK announces FDA sets tebipenem HBr PDUFA date June 18, 2026

GSK resubmitted the tebipenem HBr NDA to FDA in December 2025. In February 2026, GSK announced the FDA set the PDUFA target action date as June 18, 2026. The NDA is supported by the Phase 3 PIVOT-PO trial that was stopped early for efficacy in May 2025.

Spero: GSK files NDA resubmission for tebipenem HBr in cUTI

GSK filed an NDA resubmission for tebipenem HBr with the FDA. The filing triggers a $25 million milestone payment to Spero, expected in Q1 2026. The NDA covers the treatment of complicated urinary tract infections including pyelonephritis.