Ferric derisomaltose
Monoferric (ferric derisomaltose) is an oligosaccharide pharmaceutical. Ferric derisomaltose was first approved as Monoferric on 2020-01-16. It is used to treat iron-deficiency anemia in the USA.
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Commercial
Trade Name
FDA
EMA
Monoferric
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ferric derisomaltose
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MONOFERRIC | Pharmacosmos | N-208171 RX | 2020-01-16 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| monoferric | New Drug Application | 2022-02-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| iron-deficiency anemia | HP_0001891 | D018798 | D50 |
Agency Specific
FDA
EMA
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1437 | Injection, ferric derisomaltose, 10 mg |
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | — | — | 11 | 2 | — | 13 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 1 | 3 | — | 4 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 2 | — | 2 |
| Left ventricular dysfunction | D018487 | — | — | — | 1 | — | 1 | ||
| Iron deficiencies | D000090463 | E61.1 | — | — | — | 1 | — | 1 |
Indications Phases 2
No data
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FERRIC DERISOMALTOSE |
| INN | ferric derisomaltose |
| Description | Ferric derisomaltose (FDI), sold under the brand name Monoferric among others, is a medication for the treatment of iron deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD). It was approved for use in the United States in January 2020. It is given intravenously.
|
| Classification | Oligosaccharide |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1345510-43-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298187 |
| ChEBI ID | — |
| PubChem CID | 86278348 |
| DrugBank | DB15617 |
| UNII ID | AHU547PI9H (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 376 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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109 adverse events reported
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