Ferric Maltol Phase 3 Pediatric FORTIS Trial Results Published in Pediatric Drugs, Confirming Safety and Effectiveness in Children Aged 2 Months and Older – Shield Therapeutics

Written by Charlie King | 23 Aug 2026 | Haematology

Shield Therapeutics 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.

“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.” – Professor Richard Russell, corresponding author and Principal Investigator in the study.

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.