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Drug ReportsFerric derisomaltose
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 diseasesD006425
nutritional and metabolic diseasesD009750
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
MONOFERRICPharmacosmosN-208171 RX2020-01-16
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
monoferricNew Drug Application2024-09-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
iron-deficiency anemia—D018798D50
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ferric Derisomaltose, Monoferric, Pharmacosmos As
116334892036-06-22U-3594
88153012029-08-14DS, DPU-2734
104148312029-03-25DS, DP
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
AnemiaD000740EFO_0004272D64.9——74—11
Iron deficienciesD000090463—E61.1——83—11
Iron-deficiency anemiaD018798—D50——73—10
Heart failureD006333EFO_0003144I50——12—3
Left ventricular dysfunctionD018487—————1—1
Congenital abnormalitiesD000013EFO_0003915Q89.9———1—1
Spinal dysraphismD016135EFO_1001210Q05———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Deficiency diseasesD003677EFO_1001067E63——5——5
HypophosphatemiaD017674HP_0002148———2——2
Chronic renal insufficiencyD051436—N18——1——1
Kidney diseasesD007674EFO_0003086N08——1——1
Female genital neoplasmsD005833————1——1
Indications Phases 2
No data
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 nameFerric derisomaltose
INNferric 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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1345510-43-1
RxCUI—
ChEMBL IDCHEMBL4298187
ChEBI ID—
PubChem CID86278348
DrugBankDB15617
UNII IDAHU547PI9H (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 647 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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912 adverse events reported
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