ferric carboxymaltose
Trade name: Injectafer
Small moleculeapproved
Approved
Jul 1, 2013
Iron supplements, also known as iron salts and iron pills, are a number of iron formulations used to treat and prevent iron deficiency including iron-deficiency anemia. For prevention they are only recommended in those with poor absorption, heavy menstrual periods, pregnancy, hemodialysis, or a diet low in iron. Prevention may also be used in low birth weight babies. They are taken by mouth, injection into a vein, or injection into a muscle. While benefits may be seen in days, up to two months may be required until iron levels return to normal. — Wikipedia
Clinical trial activity
171 trials · 172 clinical orgs · 3 marketing orgs
Phase 1
6
Phase 2
75
Phase 3
58
Phase 4
68
Earliest trial started Feb 1, 2005 (NCT00396292)
Timeline
2000s
- Jan 1, 2005
Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
Daiichi Sankyo — Earliest Phase 2 Sponsor(trial)
2010s
- Jul 1, 2013
Earliest FDA Approval
- Jul 25, 2013
Lutipold — First NDA Organization
- Jul 25, 2013
Lutipold — NDA Organization
- Jul 25, 2013
Sankyo — Marketing Organization
- Jul 25, 2013
Daiichi Sankyo — NDA Secondary Org
- Jan 1, 2015
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Anemia · Phase 4
- Aneurysm · Phase 4
- Aortic Aneurysm · Phase 3
- Aortic Aneurysm, Thoracic · Phase 4
- Aortic Valve Stenosis · Phase 4
- Arterial Occlusive Diseases · Phase 4
- Arthroplasty, Replacement, Knee · Phase 4
- Atrial Fibrillation · Phase 3
- Blood Loss, Surgical · Phase 4
- Breast Neoplasms · Phase 3
- Carcinoma · Phase 3
- Cardiovascular Diseases · Phase 3
- Celiac Disease · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Colitis, Ulcerative · Phase 3
- Colorectal Neoplasms · Phase 4
- Coronary Artery Disease · Phase 4
- Crohn Disease · Phase 3
- Cystic Fibrosis · Phase 4
- Depression, Postpartum · Phase 2/Phase 3
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Endothelial Cells · Phase 4
- Familial Primary Pulmonary Hypertension · Phase 4
- Fatigue · Phase 4
- Fatigue Syndrome, Chronic · Phase 2
- Fibromyalgia · Phase 2
- Gastric Bypass · Phase 4
- Gastrointestinal Hemorrhage · Phase 4
- General Surgery · Phase 4
- Glucose Metabolism Disorders · Phase 4
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 4
- Heart Failure, Systolic · Phase 4
- Hip Fractures · Phase 4
- Hydroxocobalamin · Phase 4
- Hypophosphatemia · Phase 4
- Infant, Low Birth Weight · Phase 4
- Infertility · Phase 4
- Inflammatory Bowel Diseases · Phase 4
- Inflammatory Breast Neoplasms · Phase 3
- Intestinal Neoplasms · Phase 2
- Iron Deficiencies · Phase 4
- Kidney Diseases · Phase 4
- Liver Neoplasms · Phase 3
- Liver Transplantation · Phase 4
- Metabolic Side Effects of Drugs and Substances · Phase 4
- Mitral Valve · Phase 4
- Myocardial Infarction · Phase 4
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 4
- Organ Transplantation · Phase 3
- Orthopedic Procedures · Phase 4
- Osteoarthritis · Phase 4
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Oxidative Stress · Phase 4
- Pancreatic Neoplasms · Phase 3
- Postoperative Complications · Phase 4
- Pregnancy · Phase 4
- Pregnancy Complications · Phase 4
- Puerperal Disorders · Phase 2/Phase 3
- Pulmonary Arterial Hypertension · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Renal Insufficiency, Chronic · Phase 3
- Restless Legs Syndrome · Phase 4
- Scoliosis · Phase 2/Phase 3
- Spinal Fusion · Phase 2/Phase 3
- Stomach Neoplasms · Phase 4
- Thrombocytosis · Phase 2
- Vitamin D Deficiency · Phase 4
Mechanism of action
- Unspecified targetOTHER
Supplement
- IronSupplementation
Iron supplementation
Approval history
- approvedJul 1, 2013
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIron supplement ↗
- ChEMBLCHEMBL2108597 ↗
Also known as
- ferinject
- ferinject
- ferinject
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxymaltose
- ferric carboxy maltose
- injectafer
- injectafer
- injectafer
- injectafer
- iron carboxymaltose
- iron carboxymaltose
- iron carboxymaltose
- iron carboxymaltose
- iron dextri-maltose
- iron dextri-maltose
- iron dextri-maltose
- vit 45
- vit 45
- vit-45
- vit-45
- vit-45
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07217873 | Phase 2/Phase 3 (Phase 3) | Nov 21, 2025 | Columbia University |
| NCT06833788 | Phase 4 | Sep 30, 2025 | Assistance Publique - Hôpitaux de Paris |
| NCT07057973 | N/A | Jul 1, 2025 | Capital Medical University |
| NCT06994065 | N/A | Jun 2, 2025 | Jinnah Sindh Medical University |
| NCT06895993 | Phase 1 | Apr 7, 2025 | Boji Medical Technology Co., Ltd., Government of China, Guangzhou Jeeyor Medical Research Co.,Ltd., Jinlin University |
| NCT07053475 | Phase 4 | Apr 2, 2025 | American Regent, Inc., Western Kentucky Heart and Lung Research Foundation and Educational Trust |
| NCT07115121 | N/A | Feb 2, 2025 | RESnTEC, Institute of Research |
| NCT06434025 | Phase 3 | May 24, 2024 | Federal University of Health Science of Porto Alegre, Vifor Inc. |
| NCT06350955 | Phase 4 | May 2, 2024 | University of Lausanne |
| NCT06911034 | Phase 4 | Feb 1, 2024 | CMH Multan Institute of Medical Sciences |
| NCT05816265 | Phase 4 | Jan 31, 2024 | American Regent, Inc., University of Arizona |
| NCT05702970 | Phase 4 | Jan 15, 2024 | University of Padova |
| NCT06061393 | Phase 4 | Oct 30, 2023 | Western Galilee Hospital |
| NCT06080893 | Phase 4 | Oct 10, 2023 | Istanbul University |
| NCT06080555 | Phase 1 | Oct 9, 2023 | Boji Medical Technology Co., Ltd., Government of China, Jinlin University |
| NCT05744219 | Phase 3 | Aug 1, 2023 | Uppsala University |
| NCT05793996 | Phase 4 | Apr 28, 2023 | Russian Academy of Medical Sciences |
| NCT05669872 | N/A | Feb 28, 2023 | University of Ulsan |
| NCT05708170 | Phase 4 | Jan 31, 2023 | Liverpool Hope University, Royal Liverpool & Broadgreen University Hospitals NHS Truts |
| NCT06437080 | N/A | Oct 10, 2022 | Akram Medical Complex, G D Searle, Scotmann Pharmaceuticals, University of Health Sciences Lahore, University of the Punjab |
Showing 20 of 171 trials
Page 1 / 9
Organizations
Research & Development (172)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Vifor Inc. | For profit | 29 | 14 | 3 | 2006 |
| Daiichi Sankyo | For profit | 28 | 26 | 3 | 2005 |
| University of Zurich | Academic/Hospital | 7 | 5 | 3 | 2008 |
| University of London | Academic/Hospital | 6 | 4 | 3 | 2007 |
| American Regent, Inc. | For profit | 4 | 2 | 3 | 2019 |
| University of Oxford | Academic/Hospital | 4 | 3 | 2 | 2013 |
| J. W. Goethe University | Academic/Hospital | 3 | 3 | 2 | 2015 |
| Konkuk University | Academic/Hospital | 3 | 3 | 2 | 2016 |
| National Institute for Health Research, United Kingdom | Government | 3 | 0 | 2 | 2012 |
| Pharmacosmos | For profit | 3 | 3 | 2 | 2017 |
| University of Basel | Academic/Hospital | 3 | 2 | 2 | 2015 |
| University of Vienna | Academic/Hospital | 3 | 1 | 2 | 2008 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Boji Medical Technology Co., Ltd. | For profit | 2 | 0 | 1 | 2023 |
| British Heart Foundation | Academic/Hospital | 2 | 0 | 1 | 2013 |
| Catholic University of Korea | Academic/Hospital | 2 | 2 | 1 | 2018 |
| ClinStar, LLC | For profit | 2 | 0 | 1 | 2007 |
| Duke University | Academic/Hospital | 2 | 0 | 2 | 2017 |
| Fraunhofer | For profit | 2 | 0 | 1 | 2018 |
| Government of China | Government | 2 | 2 | 1 | 2023 |
172 organizations
Page 1 / 9
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Daiichi Sankyo | For profit | NDA2 | Jul 25, 2013 |
| Lutipold | For profit | NDA | Jul 25, 2013 |
| Sankyo | For profit | MKTG | Jul 25, 2013 |