Ferric maltol

Patients with chronic kidney disease often suffer from the comorbidity of iron deficiency anemia. Traditional oral iron preparations have clinical pain points of frequent gastrointestinal adverse reactions and insufficient absorption efficiency, and the advent of ferric maltol provides a better treatment option for such patients. As a third-generation oral iron complex anti-anemia drug, it relies on the stable complex structure of maltol and ferric iron to efficiently release iron ions in the intestinal pH environment, and can be actively absorbed by intestinal epithelial cells without gastric acid mediation, greatly reducing the risk of gastrointestinal irritation. This drug is mainly used for the treatment of iron deficiency anemia in adults, especially suitable for non-dialysis patients who are intolerant to traditional oral iron preparations or have comorbid chronic kidney disease. It can rapidly increase hemoglobin levels and improve anemia-related symptoms such as fatigue and weakness in patients.

Currently, the global prevalence of iron deficiency anemia exceeds 25%, among which the population of patients with chronic kidney disease-related anemia alone exceeds 80 million, and the market demand for oral iron preparations continues to expand. Data show that the global market size of ferric maltol had exceeded USD 320 million in 2023, with a compound annual growth rate of 12.7% in the past three years, which is significantly higher than that of traditional oral iron product categories. The domestic market is still in the introduction period at present, only the original research product has been approved for marketing, and no generic drug has been approved yet. With the improvement of the diagnosis and treatment rate of patients with chronic kidney disease and the release of demand for high-adherence iron preparations, the market growth space is broad in the future.

The original research enterprise of ferric maltol is Pharmacosmos, a British company, and the original research trade name is Feraccru®. Its core compound patent will expire in China in 2028. The currently approved original research dosage form in China is capsule, with a specification of 30mg iron per capsule, which has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. Up to now, no domestic enterprise has obtained the registration number of ferric maltol API, only the imported original research preparation has been approved for marketing, and there is no locally produced preparation product. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for ferric maltol API. Most of the products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for relevant enterprises in drug research and development, quality research and generic drug consistency evaluation.