Ferumoxytol
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FERAHEME | — | 2018-02-02 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Rienso | — | 2015-04-13 | europa.eu ↗ |
| Approved | EU (EMA) | Rienso | — | 2012-06-15 | europa.eu ↗ |
| Approved | US (FDA) | FERAHEME | — | 2009-06-30 | fda.gov ↗ |
Trials 74 · started per year
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04369560 Background | May 2025 → Jan 2028 expected | urinary bladder neoplasm | Jodi Maranchie | Recruiting | No outcome recorded |
| Phase 0 | NCT03678012 Comparator | Jun → Aug 2018 | dental caries | University of Pennsylvania | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT06440408 Background | Sep 2024 → Sep 2026 expected | primary pulmonary vein stenosis | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 1 | NCT02631733 Background | May 2017 → Nov 2019 | cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00769093 Comparator | Oct 2008 → Jul 2014 | brain neoplasm | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02189889 Comparator | Apr 2013 → Jul 2019 | anemia, cardiovascular disorder | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00659776 Comparator | Jul 2004 → Dec 2020 | nervous system disorder | Oregon Health and Science University | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02319278 Comparator | Dec 2014 → Nov 2016 | cardiac sarcoidosis, myocarditis | University of Edinburgh | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07461948 Background | Oct 2025 → Oct 2028 expected | glioblastoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT04268849 Comparator | Feb 2020 → Nov 2025 overdue | iron deficiency anemia | Auerbach Hematology Oncology Associates P C | Recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07287371 Comparator | Dec 2025 → Jun 2027 expected | iron deficiency anemia | University of Rochester | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02752191 Comparator | Apr 2016 → Dec 2018 | congenital heart disease | Paul Finn | Completed | No outcome recorded |
| Phase 4 | NCT02893293 Comparator | May 2015 → Oct 2023 | osteonecrosis | Stanford University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03777514 Comparator | Aug 2019 → Oct 2021 | post-surgical hypoinsulinemia | Johns Hopkins University | Withdrawn | No outcome recorded |
| — | NCT02070705 Background | Jan 2014 → Aug 2024 | familial pancreatic carcinoma, pancreatic adenocarcinoma, pancreatic intraductal papillary-mucinous neoplasm | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-01-05 | Takeda | AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe takeda.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 90 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ferumoxytol | “topical intra-canal irrigation with ferumoxytol (Feraheme®) diluted to 6 mg/mL in 0.1 M sodium acetate, activated with 3% H₂O₂.” NCT07518901 ↗82“Ferumoxytol (510 mg/17mL; Chia Tai Tianqing Pharmaceutical Group Co Ltd, Nanjing, China)” NCT05045872 ↗ “Ferumoxytol will be given to patients as an off-label drug as a contrast agent for MRI.” NCT05959590 ↗ “The second scan will be done 48 hours after intravenous infusion of ferumoxytol” NCT00920023 ↗ “Ferumoxytol was administered intravenously with a dose of 3 mg/kg during CMRA.” PMID 37463240 ↗ Jul 2023 “the iron oxide nanoparticle ferumoxytol (commerical name: Feraheme)” NCT07066436 ↗ “2 infusions of intravenous iron (ferumoxytol)” NCT07287371 ↗ |
| Known as | CODE 7228 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201867 ↗ |
| Known as | Feraheme | “In 2009 Ferumoxytol (Feraheme AMAG Pharmaceuticals, Inc. Lexington, MA, United States (US)) a semi-synthetic carbohydrate coated, magnetic iron oxide preparation similar to...” NCT02141490 ↗11“A derivative of ferumoxtran-10, Ferumoxytol (Feraheme AMAG Pharmaceuticals, Inc. Lexington, MA, US) has been approved for iron replacement therapy.” NCT01296139 ↗ “The investigators approach relies on the FDA-approved iron supplement ferumoxytol (Feraheme), which is used off label as a contrast agent for MRI.” NCT02893293 ↗ “Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia.” NCT04080908 ↗ “the iron oxide nanoparticle ferumoxytol (commerical name: Feraheme)” NCT07066436 ↗ “Drug: Ferumoxytol Injection [Feraheme]” NCT04253626 ↗ |
| Known as | FerahemeTM | “This MRI study involves an intravenous contrast called Ferumoxytol (FerahemeTM).” NCT02689401 ↗ |
| Known as | RIENSO | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201867 ↗ |
| Modality | Diagnostic / imaging agent | “contrast imaging agent ferumoxytol” NCT00103038 ↗ |
| Route | Intravenous | “Patients receive ferumoxytol non-stoichiometric magnetite intravenously” NCT00103038 ↗ |