ACCRUFeR® Phase 3 pediatric trial published

Results confirm safety and effectiveness of ferric maltol treatment in children 2 months and above

London, UK, 28 July 2026, Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, today announced the publication of the positive efficacy, tolerability and palatability results from the ferric maltol pediatric FORTIS clinical trial, comparing the safety and efficacy of ferric maltol and ferrous sulfate for iron deficiency anemia (IDA), in Pediatric Drugs:

Gass, D., Freiberg, A., Auth, M.K.H. and Russell R.K. Safety and Efficacy of Oral Ferric Maltol and Ferrous Sulfate for Iron Deficiency Anemia in Infants, Children and Adolescents: A Multicenter Randomized Trial.

Pediat Drugs (2026). https://doi.org/10.1007/s40272-026-00753-6

The article concluded: 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.

Key Results (as previously disclosed):

• Clinically and statistically significant Hb improvements vs. baseline were observed across all groups (ferric maltol arms and ferrous sulfate arm (P<0.0001)
• No patient discontinued ferric maltol treatment due to an adverse event compared to one patient who discontinued from the ferrous sulfate arm.
• Treatment related adverse events (AEs) were reported in 6.5% of patients treated with ferric maltol and 13% of patients treated with ferrous sulphate. No treatment related serious AEs (SAEs) were reported in either group.

Professor Richard Russell, corresponding author and Principal Investigator in the study commented: "This first full publication of results confirming the safety and effectiveness of ferric maltol treatment in children as young as 2 months is an important milestone in expanding therapeutic choices for pediatric patients, who can benefit from a much needed alternative safe and effective oral iron treatment."

The capsule formulation (30mg) of Ferric Maltol is approved for treatment of adolescents and adults aged 10 years and above (ACCRUFeR®) in the USA and 12 years and above (FeRACCRU®) in the EU. Registration of the liquid formulation used in the trial is planned to support the treatment of younger children aged 2 and above.

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients and is now the leading #1 branded prescription oral iron the market today (data source - IQVIA Xponent PlanTrak).

Details of the FORTIS/ST10-01-305 Phase 3 study

(N = 30). Children 1 months to under 2 years (N=4) were all assigned to receive ferric maltol treatment. The full data sets have been submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA.