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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Monoferric (discontinued: 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 |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| monoferric | New Drug Application | 2024-09-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| iron-deficiency anemia | — | D018798 | D50 |
Agency Specific
FDA
EMA
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1437 | Injection, ferric derisomaltose, 10 mg |
Clinical
Clinical Trials
35 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 deficiencies | D000090463 | — | E61.1 | 1 | — | 12 | 9 | 4 | 26 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 12 | 8 | 4 | 24 |
| Iron-deficiency anemia | D018798 | — | D50 | — | — | 12 | 6 | 3 | 21 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | 6 | 1 | 1 | 8 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 5 | 1 | 7 |
| Left ventricular dysfunction | D018487 | — | — | — | — | — | 1 | — | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | 1 | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | 1 | — | 1 |
| Spinal dysraphism | D016135 | EFO_1001210 | Q05 | — | — | — | 1 | — | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypophosphatemia | D017674 | HP_0002148 | — | — | — | 2 | — | — | 2 |
| Female genital neoplasms | D005833 | — | — | — | — | 2 | — | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | — | — | 1 |
| Uterine hemorrhage | D014592 | — | — | — | — | 1 | — | — | 1 |
| Emergencies | D004630 | — | — | — | — | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Peritoneal dialysis | D010530 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiac surgical procedures | D006348 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstetric labor complications | D007744 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurodevelopmental disorders | D065886 | — | F89 | — | — | — | — | 2 | 2 |
| Fetal diseases | D005315 | — | — | — | — | — | — | 1 | 1 |
| Child development | D002657 | — | — | — | — | — | — | 1 | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | — | — | — | 1 | 1 |
| Replacement arthroplasty knee | D019645 | — | — | — | — | — | — | 1 | 1 |
| Methemoglobinemia | D008708 | — | D74 | — | — | — | — | 1 | 1 |
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
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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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975 adverse events reported
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