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Tebipenem HBr

Updated ยทnext FDA decision on the calendar

Tebipenem HBr is a GSK plc, Spero Therapeutics Inc. program in Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). Every date links its source.

GSK catalyst hub · SPRO catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). 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.

Catalyst history

PDUFA · Jun 18, 2026GSKPDUFA · Jun 18, 2026SPRO

Questions

When is Tebipenem HBr's next FDA decision or readout?

No upcoming catalyst is on our calendar for Tebipenem HBr; no FDA decisions are on record below.

What happened at Tebipenem HBr's most recent FDA decision?

No FDA decision for Tebipenem HBr is in our archive yet.

What is Tebipenem HBr used for?

In our records Tebipenem HBr is under review or in development for Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).

Who makes Tebipenem HBr?

GSK plc, Spero Therapeutics Inc. (GSK, SPRO).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.