Ferric carboxymaltose
Injectafer (ferric carboxymaltose) is an unknown pharmaceutical. Ferric carboxymaltose was first approved as Injectafer on 2013-07-25.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Injectafer
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ferric carboxymaltose
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INJECTAFER | American Regent | N-203565 RX | 2013-07-25 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| injectafer | New Drug Application | 2025-01-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FERRIC CARBOXYMALTOSE, INJECTAFER, AM REGENT | |||
| 2026-05-31 | I-915 | ||
| 2024-11-19 | NPP | ||
| 2024-04-28 | NS | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ferric Carboxymaltose, Injectafer, Am Regent | |||
| 7754702 | 2028-02-15 | U-1432, U-2555, U-2556, U-2557, U-3312, U-3313, U-3314, U-3636 | |
| 8895612 | 2027-01-08 | U-1620, U-3050, U-3051, U-3115, U-3116, U-3315, U-3316, U-3635 | |
| 11364260 | 2027-01-08 | U-3637 | |
| 11433091 | 2027-01-08 | U-3435, U-3436, U-3437, U-3438, U-3634 | |
| 11478502 | 2027-01-08 | U-3472, U-3473, U-3474 | |
| 7612109 | 2025-02-05 | DS, DP | |
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1439 | Injection, ferric carboxymaltose, 1 mg |
Clinical
Clinical Trials
199 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 4 | 17 | 1 | 1 | 23 |
| Iron deficiencies | D000090463 | — | E61.1 | — | 6 | 12 | 4 | 1 | 23 |
| Iron-deficiency anemia | D018798 | — | D50 | — | 5 | 12 | 4 | 1 | 22 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | 1 | 4 | 1 | 1 | 7 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 2 | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 3 | 1 | — | — | 4 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 4 | — | — | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 4 | — | — | 4 |
| Uterine hemorrhage | D014592 | — | — | — | 1 | 2 | — | — | 3 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | 1 | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | — | — | 1 |
| Neonatal anemia | D000751 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychomotor agitation | D011595 | — | — | — | 2 | — | — | — | 2 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Hypophosphatemia | D017674 | HP_0002148 | — | — | 1 | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ferric carboxymaltose |
| INN | ferric carboxymaltose |
| Description | 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.
|
| Classification | Unknown |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 9007-72-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108597 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 6897GXD6OE (ChemIDplus, GSRS) |
Target
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,976 adverse events reported
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