Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older

LONDON, Feb. 17, 2026 /PRNewswire/ -- Shield Therapeutics plc announced that ACCRUFeR^® (ferric maltol) is the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children age 10 and older. ACCRUFeR^® has been FDA-approved and prescribed for adults with iron deficiency since 2019.

Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to menstruation and increased iron needs during puberty. Other common risk factors include not eating enough iron-rich foods, high-intensity athletic training, obesity, and growth spurts.

Early treatment of iron deficiency in children is critical. Unnoticed or untreated iron deficiency can lead to developmental delays, difficulty with learning and concentration, decreased academic performance, behavioral issues, and a weakened immune system.

Common signs of low iron in children include unusual fatigue, paleness, irritability, or difficulty keeping up in school or activities. If parents have concerns surrounding iron deficiency they should speak with their child's doctor who may recommend performing blood tests to diagnose iron deficiency or iron deficiency anemia.

Many families have experienced challenges with traditional iron supplements, which can cause stomach upset, nausea, or constipation – side effects that make it difficult for children to stick with treatment. ACCRUFeR^® was designed with tolerability in mind. For children ages 10 and up, ACCRUFeR^® is a new option that can help restore iron levels while minimizing the risk of GI side effects. 

For Important Safety Information and full Prescribing Information for ACCRUFeR^®, visit https://www.accrufer.com/product-information 

About ACCRUFeR^®/FeRACCRU^®

ACCRUFeR^®/FeRACCRU^® (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults and children age 10 and older with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR^®/FeRACCRU^®, including the product label, can be found at: www.accrufer.com and www.feraccru.com.

SOURCE Shield Therapeutics