FDA
FDA expands Accrufer approval to include patients 10 years and older
Brand name: Accrufer
Generic name: ferric maltol
Manufacturer: Shield Therapeutics
Approval date: December 22, 2025
FDA approved Accrufer (ferric maltol), an iron replacement product, for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
Efficacy
Efficacy was evaluated in pediatric patients ages 10 to 17 in the FORTIS trial (NCT05126901). The trial treated 24 patients with age-based dosing of Accrufer twice daily and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at week 12 (the average expected increase in hemoglobin with one blood transfusion).
Safety
The safety profile observed in pediatric patients was similar to that seen in adults with iron deficiency anemia. Common adverse reactions occurring in >1% of patients treated with Accrufer were flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension.
Recommended dose
The recommended dosage of Accrufer is 30 mg orally twice daily on an empty stomach 1 hour before or 2 hours after meals. Treatment duration will depend on the severity of iron deficiency and should be continued as long as necessary until ferritin levels are within the normal range.
Sources:
FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older [News release]. 2025, December 22. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-prescription-oral-medicine-iron-deficiency-pediatric-patients-ages-10-and-older
Accrufer (ferric maltol) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212320s019lbl.pdf. Revised December 2025. Accessed December 29, 2025.