Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants…

Randomized trialPaediatric drugs· Jul 2026

Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants, Children and Adolescents: A Multicenter Randomized Trial.

David Gass, Andrew Freiberg, Marcus K H Auth, Richard K Russell

HematologyRandomized trialTreatment

Oral ferric maltol significantly raised hemoglobin in children with iron deficiency anemia by 12 weeks.

Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants, Children and Adolescents: A Multicenter Randomized Trial.

David Gass … Richard K Russell

Paediatric drugs · Jul 2026

Purpose

This phase 3, multicenter, randomized, open-label study (NCT05126901) compared oral ferric maltol with ferrous sulfate, across 23 sites in the US and the UK, evaluating the safety, efficacy, pharmacokinetics, tolerability, and palatability of age-specific doses in infants, children and, adolescents with iron deficiency anemia (iron deficiency anemia).

Methods

In a 12-week study, a total of 61 children/adolescents aged 2-17 years (median age 14 years; 45 female patients [73.8%] and 16 male patients [26.2%]) with iron deficiency anemia were randomized to ferric maltol or ferrous sulfate, plus 4 infants aged 1 month to < 2 years (median age 12 months; 3 female patients [75%] and 1 male patient [25%]) were assigned to ferric maltol (open label arm).

n = 61 children

Results

extra iron gain, hemoglobin rose more with ferric maltol

OR by subgroup · 95% CI

More results

As the change was statistically significant (p < 0.0001), recruitment was stopped.

Post hoc analyses confirmed that these changes from baseline were statistically significant (p < 0.0001).

Ferric maltol increased Hb by a mean of 1.77 g/dL in the assigned infant group over 12 weeks.

More results

By day 28, this difference persisted (75.0% versus 45.8%), favoring ferric maltol (OR 0.28, 95% CI 0.07-1.05; p = 0.046).

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Conclusion

Ferric maltol significantly improved Hb levels and iron storage within 12 weeks in children aged 1 month and above, offering potentially better tolerability and palatability compared with ferrous sulfate in children and adolescents.

Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants, Children and Adolescents: A Multicenter Randomized Trial.

Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants, Children and Adolescents: A Multicenter Randomized Trial.

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