NAV

Ferric maltol

Identification

Summary

Ferric maltol is a complexed iron supplement used to treat iron deficiency in adults.

Brand Names
Accrufer
Generic Name
Ferric maltol
DrugBank Accession Number
DB15598
Background

Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate.1 Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency.2

Ferric maltol was granted FDA Approval on 25 July 2019.7

Type
Small Molecule
Groups
Approved
Structure
Similar Structures
Weight
Average: 431.154
Monoisotopic: 431.006543
Chemical Formula
C18H15FeO9
Synonyms
  • Ferric maltol
  • Iron (III) maltol
External IDs
  • ST10
  • ST10-021
  • WHO 9974
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Pharmacology

Indication

Ferric maltol is indicated to treat iron deficiency in adults.7

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofIron deficiency••••••••••••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Ferric maltol is used to provide supplemental iron to patients with an iron deficiency.7 It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity.7 Patients should be counselled regarding the risk of inflammatory bowel disease flares, iron overload, and accidental ingestion in children.7

Mechanism of action

Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1,6 in the ileum and duodenum.3 Once the iron is in circulation, it then associates with transferrin and ferritin.7

TargetActionsOrganism
UIntegrin beta-3
substrate
Humans
UNatural resistance-associated macrophage protein 2
substrate
Humans
Absorption

Ferric maltol dissociates in the gastrointestinal tract, leading to a Tmax of 1.5-3.0 hours for iron concentrations.6,7 Mean serum iron increases by 14±6µmol/L in iron deficient patients following a single dose.1 a 60mg dose is approximately 14% bioavailable.5 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 18±1% is present in the liver, and 2.6±1% is in the urine.4 Maltol has an AUC of 0.022-0.205h*µg/mL and maltol glucuronide has an AUC of 9.83-30.9h*µg/mL.8

Volume of distribution

Data regarding the volume of distribution of ferric maltol is not readily available.7,8

Protein binding

Data regarding the protein binding of ferric maltol is not readily available.7,8

Metabolism

In vitro, ferric maltol metabolism is predominantly glucuronidation of maltol by UGT1A6 and sulfation.7

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Route of elimination

39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate.7 Iron and ferric maltol are not excreted in the urine and unabsorbed ferric maltol is eliminated in the feces.6

Half-life

Maltol has a half life of 0.7h.8

Clearance

Data regarding the clearance of ferric maltol is not readily available.7,8

Adverse Effects
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Toxicity

Data regarding overdoses of ferric maltol are not readily available, however toxicity is expected with acute ingestion of 20mg/kg and 200-250mg/kg is potentially fatal.7 Patients experiencing an overdose may present with nausea, vomiting, abdominal pain, diarrhea, hypoperfusion, metabolic acidosis, and systemic toxicity.7 Overdoses should be treated with symptomatic and supportive measures which may include the use of desferroxamine.8 Hemodialysis will not remove iron but will remove the iron-desferroxamine complex.8

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
Integrate drug-drug
interactions in your software
Alendronic acidFerric maltol can cause a decrease in the absorption of Alendronic acid resulting in a reduced serum concentration and potentially a decrease in efficacy.
AlmasilateAlmasilate can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Aluminium phosphateAluminium phosphate can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Aluminum hydroxideAluminum hydroxide can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
AsenapineAsenapine can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Food Interactions
  • Take on an empty stomach.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AccruferCapsule30 mg/1OralShield TX (UK) Ltd2021-07-01Not applicableUS flag
FeraccruCapsule30 mgOralNorgine B.V.2022-06-09Not applicableEU flag
FeraccruCapsule30 mgOralNorgine B.V.2022-06-09Not applicableEU flag
FeraccruCapsule30 mgOralNorgine B.V.2022-06-09Not applicableEU flag
FeraccruCapsule30 mgOralNorgine B.V.2020-12-22Not applicableEU flag

Categories

ATC Codes
B03AB10 — Ferric maltol
Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
MA10QYF1Z0
CAS number
33725-54-1
InChI Key
AHPWLYJHTFAWKI-UHFFFAOYSA-K
InChI
InChI=1S/3C6H6O3.Fe/c3*1-4-6(8)5(7)2-3-9-4;/h3*2-3,8H,1H3;/q;;;+3/p-3
IUPAC Name
iron(3+) tris(2-methyl-4-oxo-4H-pyran-3-olate)
SMILES
[Fe+3].CC1=C([O-])C(=O)C=CO1.CC1=C([O-])C(=O)C=CO1.CC1=C([O-])C(=O)C=CO1

References

General References
  1. Kelsey SM, Blake DR, Hider RC, Gutteridge CN, Newland AC: Absorption of ferric maltol, a novel ferric iron compound, in iron-deficient subjects. Clin Lab Haematol. 1989;11(3):287-8. doi: 10.1111/j.1365-2257.1989.tb00222.x. [Article]
  2. Barrand MA, Callingham BA, Hider RC: Effects of the pyrones, maltol and ethyl maltol, on iron absorption from the rat small intestine. J Pharm Pharmacol. 1987 Mar;39(3):203-11. doi: 10.1111/j.2042-7158.1987.tb06249.x. [Article]
  3. Barrand MA, Callingham BA: Evidence for regulatory control of iron uptake from ferric maltol across the small intestine of the rat. Br J Pharmacol. 1991 Feb;102(2):408-14. doi: 10.1111/j.1476-5381.1991.tb12187.x. [Article]
  4. Barrand MA, Callingham BA, Dobbin P, Hider RC: Dissociation of a ferric maltol complex and its subsequent metabolism during absorption across the small intestine of the rat. Br J Pharmacol. 1991 Mar;102(3):723-9. doi: 10.1111/j.1476-5381.1991.tb12240.x. [Article]
  5. Kelsey SM, Hider RC, Bloor JR, Blake DR, Gutteridge CN, Newland AC: Absorption of low and therapeutic doses of ferric maltol, a novel ferric iron compound, in iron deficient subjects using a single dose iron absorption test. J Clin Pharm Ther. 1991 Apr;16(2):117-22. doi: 10.1111/j.1365-2710.1991.tb00292.x. [Article]
  6. Stallmach A, Buning C: Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-67. doi: 10.1517/14656566.2015.1096929. Epub 2015 Nov 23. [Article]
  7. FDA Approved Drug Products: Accrufer Ferric Maltol Oral Capsules [Link]
  8. EMA Summary of Product Characteristics: Feraccru [Link]
  9. Crystalline Ferric Maltol Patent [Link]
ChemSpider
148265
RxNav
2539932
Wikipedia
Ferric_maltol

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4RecruitingDiagnosticInflammatory Bowel Diseases (IBD) / Iron Deficiency (ID) / Iron Deficiency Anemia (IDA)1
4RecruitingTreatmentIron Deficiency Anemia (IDA) / Left Heart Failure1
4TerminatedTreatmentIron Deficiency Anemia (IDA) / Left Heart Failure1
3CompletedTreatmentCrohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Iron Deficiency Anemia (IDA)2
3CompletedTreatmentInflammatory Bowel Diseases (IBD) / Iron Deficiency Anemia (IDA) / Ulcerative Colitis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
CapsuleOral30 mg/1
CapsuleOral30 MG
Tablet, chewableOral100 MG
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US10179120No2019-01-152035-01-06US flag
US9802973No2017-10-312035-10-23US flag
US9248148No2016-02-022031-03-29US flag

Properties

State
Solid
Experimental Properties
PropertyValueSource
melting point (°C)300Patent
water solubility4.5-12mg/mLPatent
Predicted Properties
PropertyValueSource
Water Solubility0.0102 mg/mLALOGPS
logP2.62ALOGPS
logP0.55Chemaxon
logS-4.6ALOGPS
pKa (Strongest Acidic)9.45Chemaxon
pKa (Strongest Basic)-3.6Chemaxon
Physiological Charge0Chemaxon
Hydrogen Acceptor Count3Chemaxon
Hydrogen Donor Count0Chemaxon
Polar Surface Area49.36 Å2Chemaxon
Rotatable Bond Count0Chemaxon
Refractivity44.27 m3·mol-1Chemaxon
Polarizability11.25 Å3Chemaxon
Number of Rings3Chemaxon
Bioavailability1Chemaxon
Rule of FiveYesChemaxon
Ghose FilterYesChemaxon
Veber's RuleNoChemaxon
MDDR-like RuleNoChemaxon
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available
Chromatographic Properties
Collision Cross Sections (CCS)
Not Available

Targets

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Details1. Integrin beta-3
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Virus receptor activity
Specific Function
Integrin alpha-V/beta-3 (ITGAV:ITGB3) is a receptor for cytotactin, fibronectin, laminin, matrix metalloproteinase-2, osteopontin, osteomodulin, prothrombin, thrombospondin, vitronectin and von Wil...
Gene Name
ITGB3
Uniprot ID
P05106
Uniprot Name
Integrin beta-3
Molecular Weight
87056.975 Da
References
  1. Stallmach A, Buning C: Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-67. doi: 10.1517/14656566.2015.1096929. Epub 2015 Nov 23. [Article]
Details2. Natural resistance-associated macrophage protein 2
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Zinc ion transmembrane transporter activity
Specific Function
Important in metal transport, in particular iron. Can also transport manganese, cobalt, cadmium, nickel, vanadium and lead. Involved in apical iron uptake into duodenal enterocytes. Involved in iro...
Gene Name
SLC11A2
Uniprot ID
P49281
Uniprot Name
Natural resistance-associated macrophage protein 2
Molecular Weight
62265.195 Da
References
  1. Stallmach A, Buning C: Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-67. doi: 10.1517/14656566.2015.1096929. Epub 2015 Nov 23. [Article]

Enzymes

Details1. UDP-glucuronosyltransferase 1-6
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Protein homodimerization activity
Specific Function
UDPGT is of major importance in the conjugation and subsequent elimination of potentially toxic xenobiotics and endogenous compounds. This isoform has specificity for phenols. Isoform 3 lacks trans...
Gene Name
UGT1A6
Uniprot ID
P19224
Uniprot Name
UDP-glucuronosyltransferase 1-6
Molecular Weight
60750.215 Da
References
  1. FDA Approved Drug Products: Accrufer Ferric Maltol Oral Capsules [Link]

Transporters

Details1. Integrin beta-3
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Virus receptor activity
Specific Function
Integrin alpha-V/beta-3 (ITGAV:ITGB3) is a receptor for cytotactin, fibronectin, laminin, matrix metalloproteinase-2, osteopontin, osteomodulin, prothrombin, thrombospondin, vitronectin and von Wil...
Gene Name
ITGB3
Uniprot ID
P05106
Uniprot Name
Integrin beta-3
Molecular Weight
87056.975 Da
References
  1. Stallmach A, Buning C: Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-67. doi: 10.1517/14656566.2015.1096929. Epub 2015 Nov 23. [Article]
Details2. Natural resistance-associated macrophage protein 2
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Zinc ion transmembrane transporter activity
Specific Function
Important in metal transport, in particular iron. Can also transport manganese, cobalt, cadmium, nickel, vanadium and lead. Involved in apical iron uptake into duodenal enterocytes. Involved in iro...
Gene Name
SLC11A2
Uniprot ID
P49281
Uniprot Name
Natural resistance-associated macrophage protein 2
Molecular Weight
62265.195 Da
References
  1. Stallmach A, Buning C: Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-67. doi: 10.1517/14656566.2015.1096929. Epub 2015 Nov 23. [Article]

Drug created at December 23, 2019 20:51 / Updated at February 21, 2021 18:55