ferumoxytol
Trade name: feraheme
Approved
Jun 30, 2009
Iron(II,III) oxide, or black iron oxide, is the chemical compound with formula Fe3O4. It occurs in nature as the mineral magnetite. It is one of a number of iron oxides, the others being iron(II) oxide (FeO), which is rare, and iron(III) oxide (Fe2O3) which also occurs naturally as the mineral hematite. It contains both Fe2+ and Fe3+ ions and is sometimes formulated as FeO ∙ Fe2O3. This iron oxide is encountered in the laboratory as a black powder. It exhibits permanent magnetism and is ferrimagnetic, but is sometimes incorrectly described as ferromagnetic. Its most extensive use is as a black pigment (see: Mars Black). For this purpose, it is synthesized rather than being extracted from the naturally occurring mineral as the particle size and shape can be varied by the method of production. — Wikipedia
Clinical trial activity
83 trials · 50 clinical orgs · 5 marketing orgs
Earliest trial started Feb 1, 2004 (NCT00103038)
Timeline
2000s
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
AMAG Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
AMAG Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)
- Jun 30, 2009
AMAG Pharmaceuticals, Inc. — Earliest FDA Approval
- Jun 30, 2009
AMAG Pharmaceuticals, Inc. — NDA Secondary Org
- Jun 30, 2009
Covis — Marketing Organization
- Jun 30, 2009
AMAG Pharmaceuticals, Inc. — NDA Organization
- Jun 30, 2009
Covis — NDA Secondary Org
- Jun 30, 2009
Azurity — Marketing Organization
Indications
Studied for
- Accidents · Early Phase 1
- AIDS Dementia Complex · Phase 2
- Anemia · Phase 4
- Anemia, Iron-Deficiency · Phase 4
- Brain Injuries · Early Phase 1
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Cardiovascular Diseases · Phase 1/Phase 2
- Central Nervous System Bacterial Infections · Early Phase 1
- Central Nervous System Diseases · Early Phase 1
- Central Nervous System Neoplasms · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Colorectal Neoplasms · Phase 2
- Coronary Artery Disease · Phase 3
- Cranial Nerve Diseases · Phase 2
- Cystitis · Early Phase 1
- Dental Caries · Early Phase 1
- Dental Pulp Diseases · Phase 4
- Diagnostic Imaging · Phase 2
- Epilepsy, Temporal Lobe · Phase 2
- Esophageal Neoplasms · Phase 2
- Fetal Growth Retardation · Early Phase 1
- Glioblastoma · Phase 2
- Head and Neck Neoplasms · Early Phase 1
- Healthy Volunteers · Phase 2/Phase 3
- Heart Diseases · Phase 4
- Heart Transplantation · Phase 2/Phase 3
- Hemorrhage · Early Phase 1
- Hypoxia · Early Phase 1
- Infant, Premature, Diseases · Phase 2
- Inflammation · Phase 4
- Intracranial Aneurysm · Phase 1
- Intracranial Arteriosclerosis · Phase 4
- Iron Deficiencies · Phase 4
- Kidney Diseases · Phase 2
- Kidney Neoplasms · Phase 2
- Lung Neoplasms · Phase 2
- Menorrhagia · Phase 4
- Multiple Sclerosis · Early Phase 1
- Multiple Sclerosis, Chronic Progressive · Early Phase 1
- Myocarditis · Phase 2/Phase 3
- Neoplasms · Phase 1
- Nervous System Diseases · Phase 2
- Osteonecrosis · Phase 4
- Oxidative Stress · Phase 4
- Periapical Periodontitis · Phase 4
- Peripheral Arterial Disease · Phase 2
- Pregnancy Complications · Phase 4
- Prostatic Neoplasms · Phase 2
- Pulmonary Embolism · Phase 1/Phase 2
- Restless Legs Syndrome · Phase 2
- Stenosis, Pulmonary Vein · Phase 1
- Stroke · Phase 1
- Triple Negative Breast Neoplasms · Phase 1
- Urinary Bladder Neoplasms · Phase 2
Mechanism of action
- Unspecified targetOTHER
Unknown
Approval history
- approvedJun 30, 2009
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIron(II,III) oxide ↗
- ChEMBLCHEMBL1201867 ↗
Also known as
- ami-7228
- code 7228
- feraheme
- feraheme
- feraheme
- ferumoxytol
- ferumoxytol
- ferumoxytol
- ferumoxytol
- ferumoxytol
- ferumoxytol
- ferumoxytol
- rienso
- rienso
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07313020 | Early Phase 1 (Phase 1) | Dec 16, 2025 | Soochow University |
| NCT06483061 | Phase 2 | Dec 31, 2024 | Canadian Institutes of Health Research (CIHR), University of Alberta |
| NCT06440408 | Phase 1 | Sep 30, 2024 | University of Pennsylvania |
| NCT06348524 | Phase 3 | Aug 3, 2024 | Transmed Solutions |
| NCT05811377 | Early Phase 1 (Phase 1) | Mar 29, 2023 | Lipella Pharmaceuticals, Inc., National Institutes of Health (NIH), University of Pittsburgh |
| NCT05340465 | Phase 2 | Oct 10, 2022 | National Institutes of Health (NIH), University of Washington |
| NCT05357833 | Early Phase 1 (Phase 1) | Jun 1, 2022 | University of Utah |
| NCT04900792 | Phase 1 | Dec 31, 2021 | University of Iowa |
| NCT05515874 | Phase 4 | Aug 16, 2021 | Northwestern University, University of Chicago |
| NCT04839185 | Early Phase 1 (Phase 1) | Apr 15, 2021 | National Institutes of Health (NIH), University of Wisconsin |
| NCT06110494 | Phase 4 | Jul 13, 2020 | University of Pennsylvania |
| NCT04369560 | Early Phase 1 (Phase 1) | Jun 15, 2020 | National Cancer Institute (NCI), University of Pittsburgh |
| NCT04278651 | Phase 4 | Mar 1, 2020 | Auerbach Hematology and Oncology, Thomas Jefferson University |
| NCT04268849 | Phase 3 | Feb 17, 2020 | AMAG Pharmaceuticals, Inc., Auerbach Hematology and Oncology |
| NCT04205266 | Phase 4 | Jan 31, 2020 | AMAG Pharmaceuticals, Inc., Thomas Jefferson University |
| NCT04080908 | Phase 4 | Oct 31, 2019 | New York University |
| NCT03777514 | N/A | Aug 31, 2019 | AMAG Pharmaceuticals, Inc., Johns Hopkins University |
| NCT03893045 | Phase 3 | Jun 30, 2019 | AMAG Pharmaceuticals, Inc. |
| NCT03657433 | Phase 3 | Sep 1, 2018 | AMAG Pharmaceuticals, Inc., University of Arizona |
| NCT03619850 | Phase 3 | Aug 13, 2018 | AMAG Pharmaceuticals, Inc. |
Organizations
Research & Development (50)
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AMAG Pharmaceuticals, Inc. | For profit | NDA2 | Jun 30, 2009 |
| AMAG Pharmaceuticals, Inc. | For profit | NDA | Jun 30, 2009 |
| Azurity | For profit | MKTG | Jun 30, 2009 |
| Covis | For profit | MKTG | Jun 30, 2009 |
| Covis | For profit | NDA2 | Jun 30, 2009 |
| Novartis | For profit | MKTG | Jan 15, 2021 |
| Sandoz | For profit | MKTG | Jan 15, 2021 |
| Sandoz | For profit | SYN | Jan 15, 2021 |