Iron Replacement Therapy with Oral Ferric Maltol: Review of the Evidence and Expert Opinion

J Clin Med. 2021 Sep 28;10(19):4448. doi: 10.3390/jcm10194448.

Carsten Schmidt 1 2, Stephen Allen 3, Nelson Kopyt 4, Pablo Pergola 5


Author information

  • 1Medical Clinic II, Department of Gastroenterology, Hepatology, Endocrinology, Diabetology and Infectious Diseases, Klinikum Fulda, Pacelliallee 4, 36043 Fulda, Germany.
  • 2Medical Faculty, Friedrich Schiller University, 07747 Jena, Germany.
  • 3Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.
  • 4Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, 1230 S Cedar Crest Boulevard, Suite 301, Allentown, PA 18103, USA.
  • 5Renal Associates PA, 1123 N Main Av., Suite 120, San Antonio, TX 78212, USA.


Iron deficiency is the most common cause of anemia globally and is frequently reported in patients with underlying inflammatory conditions, such as inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Ferric maltol is a new oral iron replacement therapy designed to optimize iron absorption while reducing the gastrointestinal adverse events associated with unabsorbed free iron. Ferric maltol has been studied in clinical trials involving almost 750 adults and adolescents with iron-deficiency anemia associated with IBD, CKD, and other underlying conditions, and it has been widely used in clinical practice. It is approved for the treatment of adults with iron deficiency with or without anemia, independent of the underlying condition, and is commercially available in Europe and the United States. We review the published evidence for ferric maltol, which demonstrates consistent and clinically meaningful improvements in hemoglobin and measures of iron availability (ferritin and transferrin saturation) and shows that it is well-tolerated over long-term treatment for up to 64 weeks-an important consideration in patients with chronic underlying conditions such as IBD and CKD. We believe that ferric maltol is an effective, convenient, and well-tolerated treatment option for iron deficiency and iron-deficiency anemia, especially when long-term management of chronic iron deficiency is required. Writing support was provided by Shield Therapeutics (Gateshead, UK).

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