**Summary**
Shield Therapeutics plc announced on February 9, 2026, that the U.S. Food and Drug Administration (FDA) has granted an additional 3 years of data exclusivity for its iron deficiency treatment, ACCRUFeR® (ferric maltol), extending its exclusivity until December 19, 2028. This extension is in addition to the existing patent coverage valid until the mid-2030s. The decision was based on new clinical investigations, specifically the positive results from the Phase 3 FORTIS trial, which supported the expansion of ACCRUFeR®s indication to include pediatric patients aged 10 years and older. The trial confirmed the efficacy, safety, and tolerability of a new oral liquid formulation in children with iron deficiency anemia (IDA).
ACCRUFeR® is the first and only FDA-approved oral iron treatment for iron deficiency (ID) and IDA, addressing a significant unmet need in both adult and pediatric populations. The drug has a novel absorption mechanism and is well-tolerated, positioning it as the leading branded prescription oral iron on the market. Shield Therapeutics has partnered with various companies for the commercialization of ACCRUFeR®/FeRACCRU® globally, including Viatris in the U.S., Norgine B.V. in Europe, and others in Asia and Canada. The company’s CEO, Anders Lundstrom, and regulatory VP, Dr. Jackie Mitchell, highlighted the milestone as a recognition of the drug’s value and the company’s commitment to expanding access to this innovative therapy.