Ferric maltol
- Generic Name
- Ferric maltol
- Brand Names
- Accrufer, Feraccru
- Drug Type
- Small Molecule
- Chemical Formula
- C18H15FeO9
- CAS Number
- 33725-54-1
- Unique Ingredient Identifier
- MA10QYF1Z0
- 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. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency.
Ferric maltol was granted FDA Approval on 25 July 2019.
- Indication
Ferric maltol is indicated to treat iron deficiency in adults.
- Associated Conditions
- Iron Deficiency (ID)
Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel DiseasesIron Deficiency AnemiaIron-deficiency
- Interventions
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2023-03-31
- Lead Sponsor
- Leiden University Medical Center
- Target Recruit Count
- 90
- Registration Number
- NCT05456932
- Locations
- 🇳🇱
Radboud University Medical Center, Nijmegen, Netherlands
🇳🇱University Medical Center Groningen, Groningen, Netherlands
🇳🇱Maastricht University Medical Center+, Maastricht, Netherlands
Perioperative Iron for Colorectal Cancer (PICoC Study)
- First Posted Date
- 2022-01-04
- Last Posted Date
- 2025-01-06
- Lead Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Target Recruit Count
- 42
- Registration Number
- NCT05177484
- Locations
- 🇬🇧
The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
- Conditions
- AnemiaIron-deficiency
- Interventions
- First Posted Date
- 2021-11-19
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 65
- Registration Number
- NCT05126901
- Locations
- 🇺🇸
The Center for Clinical Trials, Saraland, Alabama, United States
🇺🇸Homestead Research Institute, Homestead, Florida, United States
🇺🇸Kissimmee Clinical Research Corp, Kissimmee, Florida, United States
Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
- Conditions
- Anemia, Iron Deficiency
- Interventions
- Drug: Ferric maltol capsule
- First Posted Date
- 2020-11-12
- Last Posted Date
- 2020-11-12
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 32
- Registration Number
- NCT04626414
- Locations
- 🇺🇸
Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, United States
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
- Conditions
- Iron Deficiency, Anaemia in ChildrenIron-Deficiency
- Interventions
- First Posted Date
- 2017-06-08
- Last Posted Date
- 2021-10-06
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 37
- Registration Number
- NCT03181451
- Locations
- 🇬🇧
Leicester Royal Infirmary, Leicester, United Kingdom
🇬🇧Nottingham University Hospital, Nottingham, United Kingdom
🇬🇧Great Ormond Street Hospital, London, United Kingdom
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
- Conditions
- Renal Insufficiency, ChronicIron-Deficiency Anemia
- Interventions
- Other: Placebo
- First Posted Date
- 2016-11-18
- Last Posted Date
- 2020-11-02
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 167
- Registration Number
- NCT02968368
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
- Conditions
- Anemia, Iron-DeficiencyCrohn's DiseaseInflammatory Bowel Disease
- Interventions
- Drug: Ferric Carboxy Maltose
- First Posted Date
- 2016-02-11
- Last Posted Date
- 2020-11-02
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 250
- Registration Number
- NCT02680756
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)
- Conditions
- Crohn's DiseaseInflammatory Bowel DiseaseIron Deficiency Anaemia
- Interventions
- Drug: Placebo oral capsule
- First Posted Date
- 2011-05-11
- Last Posted Date
- 2020-10-30
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 128
- Registration Number
- NCT01352221
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
- Conditions
- Iron Deficiency AnaemiaInflammatory Bowel DiseaseUlcerative Colitis
- Interventions
- Drug: Placebo Comparator
- First Posted Date
- 2011-04-25
- Last Posted Date
- 2020-10-30
- Lead Sponsor
- Shield Therapeutics
- Target Recruit Count
- 128
- Registration Number
- NCT01340872
Drug Development Updates
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