Drugs / Ceftibuten
Ceftibuten
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CEDAX | — | 1995-12-20 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00724256 Comparator | Jul 2006 → Jul 2009 | pyelonephritis | IRCCS Burlo Garofolo | Terminated | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-05 | Basilea Pharmaceutica | Basilea receives additional USD 5.4 million from BARDA to continue development of novel antibiotic ceftibuten-ledaborbactam basilea.com ↗ |
| 2026-05-28 | Basilea Pharmaceutica | Basilea receives further USD 13 million from BARDA to continue development of novel antibiotic ceftibuten-ledaborbactam basilea.com ↗ |
| 2026-02-25 | Basilea Pharmaceutica | Basilea receives further USD 6 million from BARDA to continue development of novel antibiotic ceftibuten-ledaborbactam basilea.com ↗ |
| 2025-09-25 | Basilea Pharmaceutica | Basilea awarded BARDA contract for the development of novel oral phase 3-ready antibiotic ceftibuten-ledaborbactam basilea.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftibuten | “Ceftibuten” NCT02099240 ↗ |
| 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 ↗ |