Ferric Maltol: Pediatric First Approval.

Ferric maltol (ACCRUFeR®), is an oral iron replacement product being developed by Shield Therapeutics plc for the treatment of iron deficiency (ID). Ferric maltol was originally approved for the treatment of iron deficiency anemia (IDA) in adult patients with inflammatory bowel disease in 2016 (with an indication extension for ID/IDA in adults in 2018) in the EU, and in ID in adults in 2019 in the USA. In December 2025 the indication in the USA was extended to include pediatric patients aged ≥ 10 years. A similar indication extension in pediatric patients aged ≥ 12 years is being evaluated in the EU. This article summarizes the milestones in the development of ferric maltol leading to this first pediatric approval for the treatment of ID.