FDA approves extension for ACCRUFeR®
Shield Therapeutics plc announced that the US FDA has approved an expanded indication for ACCRUFeR® to include adolescents aged 10 years and older with iron deficiency, following positive results from a Phase 3 pediatric trial. The company plans to seek further approval for a new pediatric formulation, a ferric maltol suspension, for children aged 1 month and above, which could also serve as an alternative for adults unable to swallow capsules. This expansion significantly broadens the market for ACCRUFeR®, which is already the number one branded prescription oral iron in the US market.
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London, UK, 22 December 2025: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA).
Shield plans to file for a further extension of the indication to include children 1 month and above in conjunction with the submission of an NDA for a new pediatric formulation (ferric maltol suspension) which was used in the successful FORTIS Phase 3 study in this population. If approved, this formulation may also offer an alternative approach for adults who can't swallow our current capsule formulation.
Anders Lundstrom, CEO of Shield, commented: "We are delighted with the FDA approval of ACCRUFeR®, making it available to the adolescent population, who now can benefit from a much needed safe and effective oral iron treatment."
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 #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, including secondary endpoints and pharmacokinetic (PK) sub-study parameters, will be submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive paediatric development program that Shield committed to implement with both the European EMA and the US FDA.
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