Tebipenem HBr is a GSK plc, Spero Therapeutics Inc. program in complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). The FDA approved it on Jun 17, 2026. 2 FDA decisions on record below. Every date links its source.
GSK catalyst hub · SPRO catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: complicated urinary tract infection (cUTI), including acute pyelonephritis (AP) (approved Jun 17, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: GSK plc, Spero Therapeutics Inc. (GSK, SPRO). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Tebipenem HBr; 2 FDA decisions are on record below.
On Jun 17, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Tebipenem HBr is FDA-approved for complicated urinary tract infection (cUTI), including acute pyelonephritis (AP) (approved Jun 17, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
GSK plc, Spero Therapeutics Inc. (GSK, SPRO).
Yes. The FDA approved an application for Tebipenem HBr on Jun 17, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.