FDA Expands Approval of Ferric Maltol to Adolescents, Addressing a Critical Gap in Iron Deficiency Care

In a significant move for pediatric health, the FDA has officially approved the extension of the indication for ferric maltol (Accrufer; Shield Therapeutics) to include children aged 10 years and older with iron deficiency (ID). This regulatory milestone expands the stable, non–salt-based oral therapy to a younger demographic that has long struggled with the limitations of traditional iron supplements.^1,2

ID remains the most common nutrient deficiency in the world, serving as a major public health hurdle. Although it is most prevalent in infants, the second most common peak occurs during adolescence, driven by the high physiological demands of rapid growth and, in girls, the onset of menstrual bleeding.² According to the World Health Organization, roughly half of all anemia cases globally are caused by ID.²

For children and teenagers, the stakes are remarkably high. Beyond simple fatigue, ID can interfere with neurodevelopment, myelination, and neurotransmission. In adolescents, this often manifests as decreased cognitive function, lower academic success, irritability, and difficulty in understanding or perception. Some patients can exhibit “pica,” the clinical sign of eating non-nutritious materials like soil or ice.²

A Solution for Unmet Needs

Until now, the standard of care for pediatric ID primarily involved oral iron salts, such as ferrous sulfate or ferrous fumarate. Although effective, these treatments are notorious for adverse effects that lead to poor patient compliance. Families often report that children suffer from nausea, vomiting, dyspepsia, and a lingering bad taste, alongside the physical discoloration of teeth and stool.²

Shield Therapeutics developed Accrufer specifically to address these drawbacks. Unlike traditional salts, Accrufer is a non–salt-based oral therapy designed to be well-tolerated and convenient. Prior to this extension, the drug was already approved for treating iron deficiency with or without anemia in adults across the US, the European Union, the UK, and Switzerland.¹

The decision to focus on the 10-plus age group aligns with the biological realities of puberty. During this stage, both boys and girls experience rapid growth spurts that deplete iron stores. Furthermore, adolescent girls are at a heightened risk; menstrual bleeding is cited as the most common cause of iron deficiency in this demographic.^1,2

Treating ID in this window is vital because the cognitive and neurophysiological effects of deficiency can sometimes last a lifetime. By providing a more tolerable oral option, health care providers hope to improve adherence rates, which often fail when patients cannot stomach the adverse effects of traditional salts.²

REFERENCES

1. US FDA approves extension of the indication for Accrufer to include children 10 years and older with iron deficiency (ID). News release. Shield Therapeutics. December 22, 2025. Accessed December 22, 2025. https://www.shieldtherapeutics.com/news/us-fda-approves-extension-indication-accruferr-include-children-10-years-and-older-iron-deficiency-id/

2. Aksu T, Unal S. Iron deficiency anemia in infancy, childhood, and adolescence. Turk Arch Pediatr. 2023;58(4):358-362.