Drugs / Ceftibuten

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CEDAX 1995-12-20 fda.gov

Trials 10 · a red edge is where a trial was stopped

19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06733675 Jan 2025 → Dec 2026 expected Basilea Pharmaceutica Recruiting No outcome recorded
Phase 1 NCT06157242 Nov 2024 → Mar 2025 bacterial infectious disease Qpex Biopharma, Inc. Completed No outcome recorded
Phase 1 NCT06665555 Nov 2024 → Mar 2025 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT06593054 Jul → Oct 2024 Pfizer Completed No outcome recorded
Phase 1 NCT06079775 Jan 2024 → Jan 2025 bacterial infectious disease Qpex Biopharma, Inc. Completed No outcome recorded
Phase 1 NCT05488678 Oct 2022 → Nov 2023 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT05554237 Oct 2022 → Jun 2023 Pfizer Completed No outcome recorded
Phase 1 NCT05527834 Sep 2022 → Feb 2023 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT04877379 Jun → Nov 2021 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT03163550 May → Oct 2017 Achaogen, Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT00724256 Comparator Jul 2006 → Jul 2009 pyelonephritis IRCCS Burlo Garofolo Terminated No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Ceftibuten CeftibutenNCT02099240
9

NCT06157242

NCT06593054

NCT06665555

NCT00724256

NCT04877379

NCT05527834

NCT06733675

NCT06079775

NCT05488678

Known as ACHN-383 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03163550
Known as CTB “In combination with ceftibuten (CTB), a third-generation oral cephalosporin, LED-E represents a potential oral β-lactam/β-lactamase inhibitor regimen for treating infections...” PMID 42008649 Apr 2026
Known as PF-06264006 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05554237
Known as VNRX-5024 VNRX-5024 (ceftibuten)” NCT04877379
Modality Small molecule “β-lactam antibiotic” NCT04877379
Route Oral oral ceftibuten” NCT00724256