Drugs / Ferumoxytol
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| Withdrawn | EU (EMA) | Rienso | — | 2015-04-13 | europa.eu ↗ |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 75 · started per year
today
US approved 2009
EU approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 011 trials | ||||||
| Phase 0 | NCT07066436 | Oct 2025 → Mar 2028 expected | diffuse large B-cell lymphoma | Medical University of Vienna | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07634640 | Nov 2023 → May 2027 expected | diastolic heart failure | University of Florida | Recruiting | No outcome recorded |
| Phase 0 | NCT05357833 | Jun 2022 → Sep 2023 | secondary progressive multiple sclerosis | University of Utah | Completed | No outcome recorded |
| Phase 0 | NCT04839185 | Apr → Oct 2021 | fetal growth restriction | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 0 | NCT02857218 | Apr 2018 → Aug 2021 | esophageal cancer | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT03280277 | Apr 2018 → Aug 2021 | rectal carcinoma | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT03179449 | Jul 2017 → Jun 2025 | brain neoplasm | Michael Iv | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT02452216 | Jun 2015 → Jan 2017 | brain cancer, brain injury, central nervous system infectious disorder, hemorrhagic stroke +4 | Michael Iv | Completed | No outcome recorded |
| Phase 0 | NCT02466828 | Mar 2015 → Apr 2018 | glioblastoma | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 0 | NCT01895829 | Sep 2013 → Sep 2021 | head and neck cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 0 | NCT00978562 | Aug 2009 → Dec 2015 | brain neoplasm | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT04900792 | Feb 2023 → May 2025 overdue | glioblastoma | Bryan Allen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05032937 | Oct 2021 → Nov 2022 | coronary atherosclerosis | The First Affiliated Hospital with Nanjing Medical University | Completed | No outcome recorded |
| Phase 1 | NCT05045872 | Sep 2021 → May 2024 | chronic kidney disease | The First Affiliated Hospital with Nanjing Medical University | Completed | No outcome recorded |
| Phase 1 | NCT03173066 | Sep 2018 → May 2022 | pulmonary embolism | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03084523 | Apr 2017 → Jun 2024 | intracranial arteriosclerosis, ischemic stroke | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT02689401 | May 2016 | esophageal cancer | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT02511028 | Nov 2015 → Aug 2018 | multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT05959590 | Feb 2014 → Aug 2019 | osteomyelitis | University of New Mexico | Completed | No outcome recorded |
| Phase 1 | NCT01770353 | Nov 2012 → Oct 2018 | hormone receptor-positive breast cancer, metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT01665846 | Jul 2011 → Jun 2012 | AIDS dementia complex | University of Hawaii | Completed | No outcome recorded |
| Phase 1 | NCT01296139 | Jan 2011 → Mar 2015 | prostate cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00360425 | May → Aug 2006 | anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01542879 | Feb 2012 → Aug 2022 | cancer | Stanford University | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07452250 | Mar → Aug 2026 overdue | vein disorder | Min Zhou | Recruiting | No outcome recorded |
| Phase 2 | NCT06483061 | May 2025 → Sep 2029 expected | temporal lobe epilepsy | University of Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT05340465 | Nov 2022 → Jan 2027 expected | disorder of iron metabolism and transport, iron deficiency anemia | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT03649880 | Jun 2019 → Jan 2029 expected | IDH-wildtype glioblastoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03347617 | Dec 2017 → Dec 2023 | glioblastoma | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03325166 | Nov 2017 → Mar 2021 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03234309 | Oct 2017 → Aug 2021 | brain neoplasm | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03270059 | Oct 2017 → Dec 2027 expected | cranial nerve neuropathy, metastatic malignant neoplasm in the brain | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02678767 | Feb 2015 → Sep 2017 | AIDS dementia complex | Beau Nakamoto | Completed | No outcome recorded |
| Phase 2 | NCT02141490 | May 2014 → Nov 2018 | kidney cancer, prostate cancer, urinary bladder cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01336803 | Aug 2011 → Jul 2014 | Ewing sarcoma, bone sarcoma, chondrosarcoma, osteomyelitis +3 | Heike E Daldrup-Link | Completed | No outcome recorded |
| Phase 2 | NCT01052779 | Mar 2010 → Jul 2011 | anemia, disorder of iron metabolism and transport, kidney disorder | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00707876 | Sep 2008 → Jul 2010 | peripheral arterial disease | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00659126 | Nov 2006 → Dec 2019 | metastatic malignant neoplasm in the brain, primary brain neoplasm | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Business |
| Phase 317 trials · 7 met primary | ||||||
| Phase 3 | NCT04253626 | Jan 2021 → Jul 2024 | iron deficiency anemia, pregnancy disorder | Stanford University | Completed | Met primary |
| Phase 3 | NCT03893045 | Sep 2019 → Jul 2026 overdue | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03657433 | Dec 2018 → Aug 2021 | iron deficiency anemia | University of Arizona | Completed | Met primary |
| Phase 3 | NCT03619850 | Aug 2018 → Aug 2026 overdue | chronic kidney disease, iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT02954510 | Feb 2017 → Nov 2023 | coronary artery disorder | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02694978 | Feb 2016 → Jan 2017 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT06348524 | Jan 2015 → Dec 2022 | coronary artery disorder | Transmed Solutions | Terminated | No outcome recorded |
| Phase 3 | NCT01264679 | Dec 2011 → Apr 2015 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01155388 | Oct 2011 → Jun 2014 | chronic kidney disease, iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01155375 | Oct 2011 → Jun 2014 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01114204 | Aug 2010 → Nov 2011 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01114217 | Jul 2010 → Sep 2012 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT01114139 | Jun 2010 → Feb 2012 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT00255450 | Jan 2005 → Aug 2006 | anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00233597 | Aug 2004 → Mar 2007 | anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT00255437 | Jun 2004 → Nov 2006 | anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00255424 | May 2004 → Aug 2006 | anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 410 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07518901 | Aug 2026 → Jun 2028 expected | acute apical periodontitis, tooth disorder | University of Pennsylvania | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT04278651 | Sep 2021 → Aug 2026 overdue | iron deficiency anemia, pregnancy disorder | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 4 | NCT05515874 | Sep 2020 → Jun 2025 | intracranial arteriosclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT06110494 | Jul 2020 → Mar 2022 | chronic apical periodontitis, dental pulp disorder | University of Pennsylvania | Completed | Missed primary |
| Phase 4 | NCT04205266 | Feb 2020 → Jan 2025 | iron deficiency anemia | Thomas Jefferson University | Unknown | No outcome recorded |
| Phase 4 | NCT04080908 | Jan 2020 → Oct 2021 | anemia | NYU Langone Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01942460 | Sep 2013 → May 2014 | iron deficiency anemia | Georges Ouellet | Completed | No outcome recorded |
| Phase 4 | NCT01227616 | Aug 2013 → Feb 2016 | chronic kidney disease, iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 4 | NCT01148745 | Mar → Apr 2010 | iron deficiency anemia | Dialysis Clinic, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00920023 | Jul 2008 → Feb 2012 | malignant pancreatic neoplasm | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT02359097 | Jan 2015 → Mar 2021 | glioblastoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| — | NCT02253602 | Sep 2014 → May 2018 | neoplasm of esophagus | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| — | NCT01983371 | Dec 2013 → Jun 2016 | colorectal cancer | Scott Potenta, MD, PhD | Withdrawn | No outcome recorded |
| — | NCT01815333 | Jul 2013 → Jul 2019 | lymph node cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT02006108 | Nov 2012 → Apr 2017 | transplant rejection | Stanford University | Completed | No outcome recorded |
| — | NCT01663090 | Sep 2012 → Nov 2016 | soft tissue sarcoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01927887 | Jul 2012 → Apr 2015 | medullary thyroid gland carcinoma, thyroid gland papillary carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT01374919 | Jun 2011 → Mar 2012 | iron deficiency anemia | Auerbach Hematology Oncology Associates P C | Completed | No outcome recorded |
| — | NCT00660543 | Dec 2006 → Jun 2014 | adult glioblastoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| — | NCT00103038 | Jun 2004 → May 2016 | lymphoma, malignant glioma, metastatic malignant neoplasm in the brain | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Comparator or background therapy15 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 1 | NCT06440408 Background | Sep 2024 → Sep 2026 overdue | 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 Stop: Enrollment |
| Phase 1/2 | NCT02189889 Comparator | Apr 2013 → Jul 2019 | anemia, cardiovascular disorder | University of Texas Southwestern Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00659776 Comparator | Jul 2004 → Dec 2020 | nervous system disorder | Oregon Health and Science University | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT02319278 Comparator | Dec 2014 → Nov 2016 | cardiac sarcoidosis, myocarditis | University of Edinburgh | Completed | No outcome recorded |
| 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 4 | NCT07287371 Comparator | Dec 2026 → Jun 2027 | iron deficiency anemia | University of Rochester | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 |
| — | 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 Stop: Business |
Press releases naming this drug 2 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 91 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 ↗83“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 ↗ |