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 · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gram-negative bacterial infections 1 milestone | |||||
| Filed | Other | — | gram-negative bacterial infections | 2024-12-03 | “our new drug application for cefiderocol, an innovative treatment for gram-negative bacterial infections, has been accepted by the Therapeutic Goods Administration (TGA) in Australia.” shionogi.com ↗ “The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024” shionogi.com ↗ |
| Filed opportunistic bacterial infectious disease 1 milestone | |||||
| Filed | US (FDA) | FETROJA® | opportunistic bacterial infectious disease | 2020-06-02 | “Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)” shionogi.com ↗ |
| Filed pyeloureteritis cystica 1 milestone | |||||
| Filed | China (NMPA) | — | pyeloureteritis cystica | 2024-08-05 | “filed a New Drug Application (NDA) for cefiderocol to the Center for Drug Evaluation, NMPA” shionogi.com ↗ |
| Approved Indication not stated 7 milestones | |||||
| Filed | US (FDA) | Fetroja | hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated urinary tract infections | 2026-07-17 | “announced the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol)” shionogi.com ↗ |
| Filed | Other | — | aerobic Gram-negative infections | 2022-12-13 | “Press release on December 13, 2022 New Drug Application of New Siderophore Cephalosporin Antibacterial Drug Cefiderocol Accepted for Review in Taiwan” shionogi.com ↗ “filed a New Drug Application (NDA) for cefiderocol, a new siderophore cephalosporin antibacterial drug, to the TFDA” shionogi.com ↗ |
| Filed | Japan (PMDA) | — | — | 2022-03-24 | “an application for manufacturing and sales approval in Japan was filed on March 24, 2022.” shionogi.com ↗ |
| Filed | Japan (PMDA) | — | — | 2021-03-24 | “Shionogi announced that Shionogi has filed for approval to manufacture and sell cefiderocol, the novel siderophore cephalosporin antibacterial drug, in Japan today.” shionogi.com ↗ |
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07104162 | Sep 2025 → Sep 2026 | bacterial infectious disease | Qpex Biopharma, Inc. | Completed | 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 Stop: Enrollment |
| Phase 26 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT02321800 | Feb 2015 → Jul 2016 | urinary tract infection | Shionogi | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT03032380 | Oct 2017 → Feb 2019 | lung disorder | Shionogi | Completed | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-09-07 | Shionogi | Regulatory Approval for Cefiderocol in Australia shionogi.com ↗
The TGA has approved cefiderocol for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options. |
| 2026-07-17 | Shionogi | Regulatory FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria Submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens shionogi.com ↗ |
| 2026-04-08 | Shionogi | Results ESCMID Global 2026: Shionogi presents new real-world data highlighting clinical effectiveness of Fetroja®/Fetcroja® (cefiderocol) in MBL-producing Enterobacterales infections shionogi.com ↗
The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieved clinical response at day 14. |
| 2026-01-08 | Shionogi | Regulatory Approval for Cefiderocol in China shionogi.com ↗
has received approval from the National Medical Products Administration (NMPA) of China for cefiderocol |
| 2025-10-21 | Shionogi | Results IDWeek 2025: Shionogi Presents Real-World and Surveillance Data Reinforcing Role of Cefiderocol Across Range of Patient Populations and Difficult-to-Treat Infections shionogi.com ↗
Latest analysis of U.S. real-world evidence demonstrates improved clinical outcomes when cefiderocol is used as earlier treatment |
| 2025-04-08 | Shionogi | Results ESCMID Global 2025: Shionogi presents real-world data demonstrating better clinical outcomes when Fetcroja® / Fetroja® (cefiderocol) is used as empiric or documented therapy as compared to salvage therapy for the treatment of Gram-negative bacterial infections shionogi.com ↗
Analysis of the European cohort found a higher clinical cure rate trend among patients who received cefiderocol for a documented infection (67.4%) or as empiric therapy (64.6%) as compared to those who received it as salvage therapy (58.2%). |
| 2025-02-21 | Shionogi | Regulatory Approval for "Fetroja®"(cefiderocol) in South Korea shionogi.com ↗
With this approval, Fetroja will be a new treatment option for patients in South Korea suffering from infections caused by multidrug-resistant. |
| 2024-12-03 | Shionogi | Regulatory Acceptance of a New Drug Application for the Gram-Negative Bacterial Infection Treatment, Cefiderocol, in Australia shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter, "Shionogi") is pleased to announce that our new drug application for cefiderocol, an innovative treatment for gram-negative bacterial infections, has been accepted by the Therapeutic Goods Administration (TGA) in Australia. |
| 2024-10-17 | Shionogi | Results IDWeek 2024: Shionogi Presents Largest Global Real-World Evidence Study of Cefiderocol Demonstrating Strong Clinical Response Rates Across Seriously Ill Patients shionogi.com ↗
Of the patients included in the analysis, 75.1% had a favorable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy). |
| 2024-08-05 | Shionogi | Regulatory New Drug Application of Novel Siderophore Cephalosporin Antibiotics, Cefiderocol, Accepted in China shionogi.com ↗
filed a New Drug Application (NDA) for cefiderocol to the Center for Drug Evaluation, NMPA (hereafter "CDE") in China, and this application has been accepted for review. |
| 2024-04-19 | Shionogi | Results ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections shionogi.com ↗
The analysis found patients receiving cefiderocol achieved an overall clinical success rate (primary endpoint, defined as the composite of clinical cure and/or survival at Day 28) of 84.3% and a 28-day all-cause mortality of 21.5%. |
| 2024-02-22 | Shionogi | Regulatory FETROJA® (cefiderocol) Approved by TFDA in Taiwan shionogi.com ↗ |
| 2024-01-31 | Shionogi | Regulatory Cefiderocol is approved for clinical use in Boao Lecheng International Medical Tourism Pilot Zone, Hainan, China shionogi.com ↗
has received approval from the Hainan Medical Products Administration for the clinical use of cefiderocol, a new siderophore cephalosporin antibiotic, in Boao Lecheng International Medical Tourism Pilot Zone, Hainan, China. |
| 2023-11-30 | Shionogi | Regulatory Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic FetrojaⓇ(cefiderocol) Intravenous Infusion 1g vial in Japan shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that FetrojaⓇ(cefiderocol) intravenous infusion 1g vial has obtained manufacturing and marketing approval from the Ministry of Health, Labour and Welfare as of today. |
| 2023-10-12 | Shionogi | Results IDWeek 2023: Shionogi Presents New Real-World Evidence Demonstrating Effectiveness of Earlier Treatment with Fetroja®(cefiderocol) in Appropriate Patients shionogi.com ↗
Analysis from a retrospective multicenter observational study showed earlier treatment resulted in a reduction of in-hospital all-cause mortality in patients with Gram-negative infections who previously received other antibiotics, including those with difficult-to-treat pathogens |
| 2023-04-17 | Shionogi | Results ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® / Fetroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens shionogi.com ↗
A retrospective chart review interim analysis demonstrated that cefiderocol achieved clinical cure in 65% and 60% of patients with Pseudomonas aeruginosa and Acinetobacter baumannii respectively, the majority of whom were severely ill with comorbidities. |
| 2022-12-13 | Shionogi | Regulatory New Drug Application of New Siderophore Cephalosporin Antibacterial Drug Cefiderocol Accepted for Review in Taiwan shionogi.com ↗
this application has been accepted for review by TFDA. |
| 2022-10-20 | Shionogi | Results Shionogi Presents Real-World Evidence Showing Strong Efficacy with Fetroja® (cefiderocol) Against Treatment Resistant Bacterial Infections at IDWeek 2022 shionogi.com ↗
New data from PROVE (Retrospective Cefiderocol Chart Review) demonstrated that Fetroja achieved clinical cure in 63% (48/76) of patients with Acinetobacter baumannii infections and 63% (76/120) of patients with Pseudomonas aeruginosa infections. |
| 2022-03-24 | Shionogi | Regulatory Regarding the Filing for Approval of Cefiderocol in Japan shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that Shionogi has filed for approval to manufacture and sell cefiderocol, the novel siderophore cephalosporin antibacterial drug, in Japan today. |
| 2021-07-08 | Shionogi | Results SHIONOGI ANNOUNCES IN VITRO AND REAL-WORLD DATA PRESENTED AT ECCMID 2021 DEMONSTRATING ACTIVITY OF CEFIDEROCOL AGAINST CRITICAL PRIORITY GRAM-NEGATIVE BACTERIAL PATHOGENS shionogi.com ↗
In vitro activity of cefiderocol has been demonstrated against the most difficult-to-treat Gram-negative bacteria, including carbapenem-resistant isolates of Pseudomonas aeruginosa, Acinetobacter baumannii-calcoaceticus complex, Stenotrophomonas maltophilia, and Enterobacterales collected from across Europe and the US. |
| 2020-10-14 | Shionogi | Results SHIONOGI ANNOUNCES PUBLICATION OF TWO STUDIES IN THE LANCET INFECTIOUS DISEASES HIGHLIGHTING THE EFFICACY AND SAFETY OF CEFIDEROCOL FOR THE TREATMENT OF INFECTIONS DUE TO AEROBIC GRAM-NEGATIVE BACTERIA IN ADULTS WITH LIMITED TREATMENT OPTIONS shionogi.com ↗
APEKS-NP demonstrated that cefiderocol is an effective and well tolerated treatment option for Gram-negative nosocomial pneumonia infections, including Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacterales, in critically ill patients including those who are at risk of multi-drug resistant (MDR) infection[i] |
| 2020-09-29 | Shionogi | Regulatory SHIONOGI ANNOUNCES FDA APPROVAL OF FETROJA® (CEFIDEROCOL) FOR THE TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA shionogi.com ↗ |
| 2020-09-04 | Shionogi | Regulatory SHIONOGI GRANTED NEW TECHNOLOGY ADD-ON PAYMENT FOR FETROJA® (CEFIDEROCOL) BY CMS Add-on Payment to Reimburse Hospitals up to 75 Percent of the cost of FETROJA in Hospital Inpatient Setting shionogi.com ↗
Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for FETROJA® (cefiderocol) when administered in the hospital inpatient setting. |
| 2020-06-02 | Shionogi | Regulatory FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia shionogi.com ↗
Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens. |
All press releases naming this drug 36 releases
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 NCT04215991 ↗ |
| 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 ↗ |