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

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MOLSDFPDBSMILESInChI

Similar Structures

Structure for Ferric maltol (DB15598)

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Weight

Average: 431.154
Monoisotopic: 431.006543

Chemical Formula

C₁₈H₁₅FeO₉

Synonyms

• Ferric maltol
• Iron (III) maltol

External IDs

• ST10
• ST10-021
• WHO 9974

Pharmacology

Indication

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

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Associated Conditions

• Iron Deficiency (ID)

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

Target	Actions	Organism
UIntegrin beta-3	substrate	Humans
UNatural resistance-associated macrophage protein 2	substrate	Humans

Absorption

Ferric maltol dissociates in the gastrointestinal tract, leading to a T_max 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

Hover over products below to view reaction partners

• Ferric maltol
  • Maltol Glucuronide

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.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
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Alendronic acid	Ferric maltol can cause a decrease in the absorption of Alendronic acid resulting in a reduced serum concentration and potentially a decrease in efficacy.
Almasilate	Almasilate can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Aluminium phosphate	Aluminium phosphate can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Aluminum hydroxide	Aluminum hydroxide can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Asenapine	Asenapine can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium carbonate	Calcium carbonate can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium Phosphate	Ferric maltol can cause a decrease in the absorption of Calcium Phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium phosphate dihydrate	Ferric maltol can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Carbamazepine	The metabolism of Ferric maltol can be increased when combined with Carbamazepine.
Carbidopa	Ferric maltol can cause a decrease in the absorption of Carbidopa resulting in a reduced serum concentration and potentially a decrease in efficacy.

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Food Interactions

• Take on an empty stomach.

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Accrufer	Capsule	30 mg/1	Oral	Shield TX (UK) Ltd	2021-07-01	Not applicable
Feraccru	Capsule	30 mg	Oral	Norgine B.V.	2022-06-09	Not applicable
Feraccru	Capsule	30 mg	Oral	Norgine B.V.	2022-06-09	Not applicable
Feraccru	Capsule	30 mg	Oral	Norgine B.V.	2020-12-22	Not applicable
Feraccru	Capsule	30 mg	Oral	Norgine B.V.	2022-06-09	Not applicable

Categories

ATC Codes

B03AB10 — Ferric maltol

• B03AB — Iron trivalent, oral preparations
• B03A — IRON PREPARATIONS
• B03 — ANTIANEMIC PREPARATIONS
• B — BLOOD AND BLOOD FORMING ORGANS

Drug Categories

• Antianemic Preparations
• Blood and Blood Forming Organs
• Hematinics
• Hematologic Agents
• Iron Compounds
• Iron Preparations
• Iron Trivalent, Oral Preparations
• Organometallic Compounds
• Parenteral Iron Replacement
• Pyrans
• UGT1A6 substrate

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]

External Links

ChemSpider

148265

RxNav

2539932

Wikipedia

Ferric_maltol

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
4	Recruiting	Diagnostic	Inflammatory Bowel Diseases (IBD) / Iron Deficiency (ID) / Iron Deficiency Anemia (IDA)	1
4	Recruiting	Treatment	Iron Deficiency Anemia (IDA) / Left Heart Failure	1
4	Terminated	Treatment	Iron Deficiency Anemia (IDA) / Left Heart Failure	1
3	Completed	Treatment	Crohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Iron Deficiency Anemia (IDA)	2
3	Completed	Treatment	Inflammatory Bowel Diseases (IBD) / Iron Deficiency Anemia (IDA) / Ulcerative Colitis	1
3	Completed	Treatment	Iron Deficiency Anemia (IDA) / Renal Insufficiency,Chronic	1
3	Recruiting	Treatment	Anemia / Iron Deficiency (ID)	1
3	Recruiting	Treatment	Colon Cancer	1
3	Terminated	Treatment	Iron Deficiency Anemia (IDA) / Pulmonary Hypertension (PH)	1
1	Completed	Other	Iron Deficiency (ID) / Iron Deficiency, Anaemia in Children	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Capsule	Oral	30 mg/1
Capsule	Oral	30 MG
Tablet, chewable	Oral	100 MG

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
US10179120	No	2019-01-15	2035-01-06
US9802973	No	2017-10-31	2035-10-23
US9248148	No	2016-02-02	2031-03-29

Properties

State

Solid

Experimental Properties

Property	Value	Source
melting point (°C)	300	Patent
water solubility	4.5-12mg/mL	Patent

Predicted Properties

Property	Value	Source
Water Solubility	0.0102 mg/mL	ALOGPS
logP	2.62	ALOGPS
logP	0.55	Chemaxon
logS	-4.6	ALOGPS
pKa (Strongest Acidic)	9.45	Chemaxon
pKa (Strongest Basic)	-3.6	Chemaxon
Physiological Charge	0	Chemaxon
Hydrogen Acceptor Count	3	Chemaxon
Hydrogen Donor Count	0	Chemaxon
Polar Surface Area	49.36 Å2	Chemaxon
Rotatable Bond Count	0	Chemaxon
Refractivity	44.27 m3·mol-1	Chemaxon
Polarizability	11.25 Å3	Chemaxon
Number of Rings	3	Chemaxon
Bioavailability	1	Chemaxon
Rule of Five	Yes	Chemaxon
Ghose Filter	Yes	Chemaxon
Veber's Rule	No	Chemaxon
MDDR-like Rule	No	Chemaxon

Predicted ADMET Features

Not Available

Spectra

Mass Spec (NIST)

Not Available

Spectra

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]

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