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
- 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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- 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 substrateHumans UNatural resistance-associated macrophage protein 2 substrateHumans - 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
Hover over products below to view reaction partners
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAlendronic 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. Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- Take on an empty stomach.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- 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 US Feraccru Capsule 30 mg Oral Norgine B.V. 2022-06-09 Not applicable EU Feraccru Capsule 30 mg Oral Norgine B.V. 2022-06-09 Not applicable EU Feraccru Capsule 30 mg Oral Norgine B.V. 2020-12-22 Not applicable EU Feraccru Capsule 30 mg Oral Norgine B.V. 2022-06-09 Not applicable EU
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
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- FDA Approved Drug Products: Accrufer Ferric Maltol Oral Capsules [Link]
- EMA Summary of Product Characteristics: Feraccru [Link]
- Crystalline Ferric Maltol Patent [Link]
- External Links
- ChemSpider
- 148265
- 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 US US9802973 No 2017-10-31 2035-10-23 US US9248148 No 2016-02-02 2031-03-29 US
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

- 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
- 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]
- 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
- 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
- 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
- FDA Approved Drug Products: Accrufer Ferric Maltol Oral Capsules [Link]
Transporters
- 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
- 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]
- 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
- 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