FDA approves Spero Therapeutics' Utebzi, first oral carbapenem for cUTIs

Spero Therapeutics, Inc.

Utebzi (tebipenem pivoxil) approved June 17, 2026 for complicated UTIs in adults with limited oral alternatives.
PIVOT-PO trial showed 58.5% overall success vs 60.2% for IV imipenem-cilastatin (adjusted diff -1.3%).
Most common AEs were diarrhea and headache; all mild/moderate and non-serious.
GSK holds exclusive global license (excl. select Asia); BARDA supported development.
Product anticipated to be available in US by end of 2026.

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