Iron Deficiency in Pediatric Patients
ACCRUFeR® (ferric maltol) is the only FDA-approved branded oral iron treatment for children 10 years of age and older.2,60
2.4 million children in the U.S. have ID/IDA58
Left untreated, ID can lead to long-term issues that may not be reversable including:59
- Neurocognitive deficits: Impaired attention, memory, and information processing.
- Developmental motor delays: Impaired motor skills and coordination.
- Behavioral dysfunction: Compromised emotional regulation and reduced inhibitory function.
Up to 60% of patients will discontinue treatment with traditional ferrous salts because of adverse reactions.32
An effective, tolerable iron treatment option is critical to raise iron levels and reduce the risk of long-term health impacts for children with iron deficiency.
The ACCRUFeR impact
ACCRUFeR achieved FDA approval based on three randomized, placebo-controlled trials in adults and one open-label study in children.2 For pediatric patients, ACCRUFeR’s MALTOL SHIELD™ makes the difference, demonstrating the following benefits:
ACCRUFeR’s safety profile in children with IDA is consistent with the safety profile reported in adult patients with IDA.2
In adult studies, ACCRUFeR demonstrated a 2.25 g/dL mean Hb change (vs 0.06 g/dL with placebo) from baseline to week 12. Statistical significance achieved by week 4.1,2
Patients take a 30 mg gluten-free capsule twice a day. With this dosing in adult studies, treatment did not lead to iron overload.2
In adult studies, 4.6% of patients taking ACCRUFeR (n=175) discontinued treatment due to adverse GI reactions, compared with 2.5% of patients taking a placebo (n=120).2,7
Proven efficacy in pediatric patients
ACCRUFeR demonstrated safety and efficacy in pediatric patients (ages 10 to <18) with IDA.2
*Not actual patient.
Pediatric Patients with IDA2
| Endpoint | ACCRUFeR |
|---|---|
|
Primary: Hb g/dL |
+1.10 (1.06) |
|
Secondary: Ferritin, mcg/L |
+8.6 (10.29) |
Study Description:2
- 12-week open-label study
- 24 patients ages 10 to <18 years with IDA
References:
1. Schmidt C, Ahmad T, Tulassay Z, et al. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a phase 3 study. Aliment Pharmacol Ther. 2016;44(3):259-270. doi:10.1111/apt.13665
2. ACCRUFeR® full prescribing information. Shield Therapeutics, 2025.
3. Stallmach A, Büning C. Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-2867. doi:10.1517/14656566.2015.1096929
4. European Medicines Agency. https://www.ema.europa.eu/en/documents/variation-report/feraccru-h-c-2733-ii-0010-epar-assessment-report-variation_en.pdf.
5. Gasche C, Ahmad T, Zsolt T, et al. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015;21:579-588.
6. Pergola PE, Kopyt NP. Oral ferric maltol for the treatment of iron-deficiency anemia in patients with CKD: a randomized trial and open-label extension. Am J Kidney Dis. 2021;78(6):846-856.el. doi:10.1053/j.ajkd.2021.03.020
7. Data on file. Shield Therapeutics Inc. 2019.
32. Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, et al. Tolerability of different oral iron supplements: A systematic review. Curr Med Res Opin. 2013;29(4):291-303. doi:10.1185/03007995.2012.761599.
58. Brotanek JM, et al (2007)
59. Theola J, Andriastuti M. Neurodevelopmental impairments as long-term effects of iron deficiency in early childhood: A systematic review. Balkan Med J. 2025;Mar 3;42(2):108-120. doi: 10.4274/balkanmedj. galenos.2025.2024-11-24. Epub 2025 Jan 31
60. Data on File. Shield Therapeutics Inc. 2025