FDA Expands Ferric Maltol Approval for Adolescents – Iron Deficiency Treatment

FDA Expands Approval of Ferric Maltol to include Children Aged 10 and Older with Iron Deficiency

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 customary iron supplements.^1,2

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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 Association, 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. Even though effective, these tre

FDA Expands Approval of Accrufer for Iron Deficiency in Children Aged 10 and Older

The U.S. Food and Drug management (FDA) has approved an expanded indication for Accrufer (ferric maltol), allowing its use in children 10 years and older with iron deficiency (ID).¹ Previously approved for adults with iron deficiency, this expansion offers a new oral treatment option for a condition that can have lasting cognitive and neurophysiological effects if left untreated.

Iron deficiency is a common issue in children and adolescents, potentially impacting advancement and overall health. Traditional iron supplements can be difficult for patients to tolerate due to gastrointestinal side effects, leading to poor adherence. Accrufer is designed to be a more tolerable oral option, potentially improving treatment success rates.²

“Treating ID in this window is vital because the cognitive and neurophysiological effects of deficiency can sometimes last a lifetime,” the source material states.By offering a better-tolerated oral formulation, healthcare providers aim to increase adherence, a common challenge with conventional iron salts.

The approval is based on data demonstrating the efficacy and safety of Accrufer in this expanded age group, as announced by Shield Therapeutics.¹ Iron deficiency anemia in children is a significant health concern, and effective treatment is crucial for optimal growth and development, as highlighted in research published in Turk Arch Pediatr.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.

2. Aksu T, Unal S. Iron deficiency anemia in infancy, childhood, and adolescence. Turk Arch Pediatr. 2023;58(4):358-362. https://pubmed.ncbi.nlm.nih.gov/37397491/

Note: I have added a direct link to the PubMed abstract for the Aksu & Unal study for increased authoritativeness and ease of access. I also ensured all links are functional and relevant.the date in the Shield Therapeutics press release was maintained as provided in the source material.