Ferric maltol

Table of contents

• What is ferric maltol?
• How does ferric maltol work?
• Which conditions is ferric maltol used or studied for?
• How is ferric maltol given?
• What do the clinical trials show?
• What side effects are known?

What is ferric maltol?

Ferric maltol is a chemically synthesised iron-containing substance classified under ATC code B03AB10, a group of oral iron preparations used in haematology.^[1] It is authorised as a medicine in the European Union under the trade name Feraccru 30 mg hard capsules, with the marketing authorisation held by Norgine B.V.^[1] In NHS formulary documents it is described as a second-line option for treating iron deficiency anaemia, to be prescribed after two standard oral iron preparations have failed and when an iron infusion is being considered.^[3]

How does ferric maltol work?

Ferric maltol supplies iron in a form that can be taken by mouth. Iron is needed to make haemoglobin, the protein in red blood cells that carries oxygen. The maltol component forms a stable complex with ferric iron, which is intended to allow the iron to be absorbed from the gut while reducing the amount of free iron that can cause gastrointestinal irritation. NHS formulary entries note that gastro-intestinal side effects are related to the iron content, and that preparations containing less iron have a lower incidence of side effects.^[4]

Which conditions is ferric maltol used or studied for?

• Iron deficiency anaemia — the main condition for which ferric maltol is used, particularly in adults who have not responded to or cannot tolerate standard oral iron salts.^[3]
• Iron deficiency anaemia in adults with mild to moderate inflammatory bowel disease (IBD) — one formulary lists ferric maltol as second line for patients with IBD who have failed two oral ferrous products.^[4]
• Iron deficiency in women — the registered clinical trial studies ferric maltol in iron-deficient women, measuring normalisation of haemoglobin.^[1]

How is ferric maltol given?

Ferric maltol is given as hard capsules for oral use, at a strength of 30 mg per capsule.^[1] The Nottinghamshire formulary states a recommended dose of 30 mg twice daily, with a local recommendation to check full blood count and ferritin after the first month of treatment.^[5] The Milton Keynes formulary notes a usual treatment duration of 12 weeks.^[4]

What do the clinical trials show?

One registered clinical trial investigates ferric maltol in the EU Clinical Trials Information System. The study (2025-522004-24-00) is a prospective, open-label, randomised, interventional study comparing Sucrosomial® iron with Feraccru 30 mg hard capsules in 146 iron-deficient women.^[1] It is classified as a low-intervention trial and is currently authorised, meaning it has received regulatory approval to proceed.^[1]

The primary outcome is the proportion of patients who achieve haemoglobin normalisation at the end of the 12-week treatment period, defined as a haemoglobin level of 12 g/dl or higher.^[1] The study is designed to determine the efficacy of sucrosomial iron versus ferric maltol in achieving normalisation of haemoglobin levels.^[1] Ferric maltol is the test substance in this trial, meaning it is one of the active treatments being investigated.^[1]

What side effects are known?

NHS formulary sources note that gastro-intestinal side effects are a recognised issue with oral iron preparations generally, and that these side effects are related to the iron content of the preparation.^[4] Ferric maltol is positioned in formularies as an option for patients with significant intolerance to standard oral iron replacement therapy, which reflects its intended role in reducing such side effects.^[5] The Cheshire and Merseyside formulary advises prescribers to consult the Summary of Product Characteristics for information on product constituents which may cause allergy.^[2]