Drugs / Cefiderocol
Cefiderocol
also known as
Cefiderocol sulfate tosilate · CEFIDEROCOL SULFATE TOSYLATE · Cefiderocol tosilate sulfate hydrate · Fetcroja · Fetroja · GSK-2696266 · GSK-2696266D · RSC-649266 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FETROJA | — | 2020-09-25 | fda.gov ↗ |
| Approved | EU (EMA) | Fetcroja | — | 2020-04-23 | europa.eu ↗ |
| Approved | US (FDA) | FETROJA | — | 2019-11-14 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07104162 | Sep 2025 → Jul 2026 overdue | bacterial infectious disease | Qpex Biopharma, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06547554 | Sep 2024 → Oct 2025 | bacterial infectious disease | Qpex Biopharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05373615 | Jul 2022 → Nov 2024 | — | Hartford Hospital | Completed | No outcome recorded |
| Phase 1 | NCT05395104 | May → Jul 2022 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04995835 | Jul 2021 → Jun 2024 | infectious disease with sepsis | Joseph L. Kuti, PharmD | Completed | No outcome recorded |
| Phase 1 | NCT03862040 | Feb → Oct 2019 | bacterial pneumonia | Shionogi | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07431307 | Jul 2026 → Mar 2028 expected | bacterial meningitis, bacterial pneumonia | BioVersys AG | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06086626 | Mar 2024 → Mar 2025 | gram-negative bacterial infections | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT04335539 | Aug 2020 → Feb 2023 | gram-negative bacterial infections, infectious disease with sepsis, urinary tract infection | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT04215991 | Feb 2020 → Sep 2024 | bacterial pneumonia, gram-negative bacterial infections, urinary tract infection | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT03869437 | Oct 2019 → Nov 2023 | bacterial infectious disease | The University of Queensland | Completed | No outcome recorded |
| Phase 2 | NCT02321800 | Feb 2015 → Jul 2016 | urinary tract infection | Shionogi | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03032380 | Oct 2017 → Feb 2019 | lung disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT02714595 | Sep 2016 → Apr 2019 | bacterial infectious disease with sepsis, bacterial urinary tract infection, lung disorder | Shionogi | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07465432 | Feb 2026 → Feb 2027 expected | — | University of Tennessee | Recruiting | No outcome recorded |
| Phase 4 | NCT05922124 | Sep 2024 → Jul 2026 overdue | Acinetobacter infectious disease | Rambam Health Care Campus | Recruiting | No outcome recorded |
| Phase 4 | NCT05314764 | Jun 2022 → Jun 2024 | bacterial pneumonia, cystic fibrosis | Hartford Hospital | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03780140 | — | gram-negative bacterial infections | Shionogi | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cefiderocol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04995835 ↗ |
| Known as | Cefiderocol sulfate tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | CEFIDEROCOL SULFATE TOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | Cefiderocol tosilate sulfate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | Fetcroja | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | Fetroja | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | GSK-2696266 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | GSK-2696266D | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | RSC-649266 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Known as | S-649266 | “S-649266” NCT03869437 ↗ |
| Known as | S-649266D | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989974 ↗ |
| Action | Inhibit | “the resulting complex of cefiderocol and iron ions is actively transported into bacteria via ferric iron transporter systems with subsequent destruction of cell wall synthesis.” NCT03869437 ↗ |
| Modality | Small molecule | “new siderophore cephalosporin” PMID 30509675 ↗ Oct 2018 |
| Route | Intravenous | “2 g intravenously over 3 hours” NCT02714595 ↗ |