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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 anemiaD018798D50
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
Iron deficienciesD000090463E61.111138427
AnemiaD000740EFO_0004272D64.91138426
Iron-deficiency anemiaD018798D501128324
Deficiency diseasesD003677EFO_1001067E6316119
Heart failureD006333EFO_0003144I501517
Left ventricular dysfunctionD01848711
Birth weightD001724EFO_000434411
Congenital abnormalitiesD000013EFO_0003915Q89.911
Spinal dysraphismD016135EFO_1001210Q0511
SepsisD018805EFO_0001420A41.911
Show 5 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypophosphatemiaD017674HP_000214822
Female genital neoplasmsD00583322
Chronic renal insufficiencyD051436N1811
Kidney diseasesD007674EFO_0003086N0811
HemorrhageD006470MP_0001914R5811
Uterine hemorrhageD01459211
EmergenciesD00463011
PregnancyD011247EFO_0002950Z33.111
Peritoneal dialysisD01053011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiac surgical proceduresD00634811
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstetric labor complicationsD00774411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neurodevelopmental disordersD065886F8922
Fetal diseasesD00531511
Child developmentD00265711
Autism spectrum disorderD000067877F84.011
Replacement arthroplasty kneeD01964511
MethemoglobinemiaD008708D7411
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 662 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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