The U.S. Food and Drug Administration has approved ACCRUFeR® (ferric maltol), developed by Shield Therapeutics, as the first and only prescription oral iron therapy for children aged 10 years and older. Previously, ACCRUFeR® has been prescribed to adults with iron deficiency since 2019. This approval expands its use and represents a major advance in addressing iron deficiency in young patients.
The U.S. Food and Drug Administration has approved ACCRUFeR® (ferric maltol), developed by Shield Therapeutics, as the first and only prescription oral iron therapy for children aged 10 years and older. Previously, ACCRUFeR® has been prescribed to adults with iron deficiency since 2019. This approval expands its use and represents a major advance in addressing iron deficiency in young patients.
Iron deficiency affects roughly 2.4 million children in the United States. It becomes especially common during adolescence, when rapid growth and, in females, menstrual blood loss increase iron needs. Experts estimate that up to 40 percent of females aged 12–21 may experience iron deficiency. If untreated, it can reduce oxygen delivery, lower energy, and affect overall well-being.
Healthcare professionals and families have welcomed this approval. Early intervention can prevent developmental challenges. If iron deficiency progresses to anemia, children may experience fatigue, learning difficulties, weakened immunity, and reduced academic performance. The increasing prevalence of iron deficiency and the massive amount of iron deficiency anemia are widespread globally, particularly in children, highlighting the importance of regular iron deficiency testing. Doctors emphasize timely diagnosis and treatment for children who show signs of low iron, including paleness, irritability, lethargy, and difficulty keeping up with daily activities.
Traditional iron supplements often cause gastrointestinal side effects such as nausea, constipation, and abdominal discomfort. These effects can make it hard for children to follow a treatment plan, leaving iron deficiency untreated despite medical advice. ACCRUFeR® (ferric maltol) is designed to be well-tolerated and effective for children 10 years and older.
The FDA’s decision followed clinical trials showing that ACCRUFeR® is safe and effective in pediatric patients. Its unique formulation allows iron absorption in the small intestine with fewer gastrointestinal side effects than many traditional iron salts. Improved tolerability may boost adherence to therapy, which is essential for replenishing iron stores and preventing progression of deficiency.
The FDA also granted Shield Therapeutics plc three additional years of data exclusivity for ACCRUFeR®, based on the clinical investigation that supported the pediatric indication. This exclusivity will last until December 19, 2028, reinforcing the company’s market position and ensuring patient access.
Iron is essential for producing hemoglobin, which carries oxygen in the blood. Iron deficiency is the most common cause of anemia worldwide. Outside the U.S., ACCRUFeR® has gained approval or marketing authorization in markets including Canada and South Korea, offering a prescription alternative to over-the-counter iron supplements.
Shield Therapeutics plans to pursue further regulatory approvals. They are developing a pediatric liquid formulation to reach younger children and patients who cannot swallow capsules. This will broaden ACCRUFeR®’s clinical utility.
Pediatricians and pediatric hematologists hope the approval will close a longstanding care gap. ACCRUFeR® provides a well-tolerated oral therapy as an alternative to more invasive options, such as intravenous iron or blood transfusions, which may be used when traditional supplements fail or are not tolerated.
Parents who notice signs of iron deficiency in their children should consult a healthcare provider for evaluation and testing. Early diagnosis allows targeted treatment before the deficiency affects growth, development, or school performance. With ACCRUFeR® now available for children in the United States, clinicians can manage iron deficiency across a broader age range and support young patients’ health and vitality.
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