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Accrufer, Feraccru(ferric maltol)
Accrufer, Feraccru (ferric maltol) is a small molecule pharmaceutical. Ferric maltol was first approved as Feraccru on 2016-02-18. It has been approved in Europe to treat iron-deficiency anemia.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Accrufer
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ferric maltol
Tradename
Company
Number
Date
Products
ACCRUFERShield TherapeuticsN-212320 RX2019-07-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
accruferNew Drug Application2021-01-18
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
FERRIC MALTOL, ACCRUFER, SHIELD TX
2024-07-25NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ferric Maltol, Accrufer, Shield Tx
98029732035-10-23DS, DPU-2603
101791202035-01-06U-2603
92481482031-03-29U-2603
ATC Codes
B: Blood and blood forming organ drugs
— B03: Antianemic preparations
— B03A: Iron antianemic preparations
— B03AB: Iron trivalent, oral antianemic preparations
— B03AB10: Ferric maltol
HCPCS
No data
Clinical
Clinical Trials
12 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 anemiaD018798HP_0001891D502—63—11
Inflammatory bowel diseasesD015212EFO_0003767——31—4
Heart failureD006333EFO_0003144I50———2—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Crohn diseaseD003424EFO_0000384K50——2——2
Pulmonary hypertensionD006976EFO_0001361I27.20——1——1
Chronic renal insufficiencyD051436N18——1——1
Ulcerative colitisD003093EFO_0000729K51——1——1
AnemiaD000740EFO_0004272D64.9——1——1
Colonic neoplasmsD003110C18——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 MALTOL
INNferric maltol
Description
Ferric maltol, sold under the brand names Accrufer (US) and Feraccru (EU), is an iron containing medication for the treatment of adults with low iron stores. It is taken by mouth.
Classification
Small molecule
Drug classHematologic agents
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1occc(=O)c1[O-].Cc1occc(=O)c1[O-].Cc1occc(=O)c1[O-].[Fe+3]
Identifiers
PDB—
CAS-ID33725-54-1
RxCUI—
ChEMBL IDCHEMBL4298110
ChEBI ID—
PubChem CID169535
DrugBankDB15598
UNII IDMA10QYF1Z0 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 95 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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424 adverse events reported
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