Anagrelide

Thrombocythemia is a type of myeloproliferative disorder characterized by abnormally elevated platelet levels. Patients with this condition have significantly increased risks of thrombosis and bleeding, and there has long been a lack of targeted platelet-lowering treatment regimens with low adverse reactions. Anagrelide is an imidazoquinazoline antiplatelet drug. It can reduce excessive platelet production by inhibiting the maturation and differentiation of megakaryocytes, while not significantly affecting white blood cell and red blood cell counts. It is currently the only approved selective platelet-lowering drug in the world, and is clinically mainly used to treat thrombocythemia caused by essential thrombocythemia and other myeloproliferative disorders, especially suitable for patients who cannot tolerate hydroxyurea treatment.

At present, the global market size of anagrelide is approximately USD 210 million, with a compound annual growth rate maintained at around 4.2%. The growth momentum mainly comes from the year-on-year increase in the prevalence of myeloproliferative disorders and the rising demand of patients for long-term low-toxicity treatment regimens. In terms of competitive landscape, the original research product still accounts for more than 60% of the global market share, and the Chinese market is still in its infancy. At present, 3 domestic enterprises have obtained approval for generic preparations of anagrelide. Coupled with the inclusion of anagrelide in the medical insurance catalogs in multiple provinces since 2022, the accessibility of the drug for patients has been greatly improved, driving the continuous rise in demand for the active pharmaceutical ingredient (API).

The original research enterprise of anagrelide is Roberts Pharmaceutical Corporation, and the original brand name is Agrylin. The core compound patent expired globally in 2008, and currently the preparation patents of the original research product in major global markets have all become invalid. The main dosage form of the original research product is oral capsule, with two specifications of 0.5 mg and 1 mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the China Listed Drug Catalog. In terms of domestic API registration, at present, 5 enterprises have obtained CDE registration numbers for anagrelide APIs with the status of A, and 4 domestic generic preparations have been approved for marketing, covering the above two specifications. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for anagrelide API. Most of the products are available from stock. For in-stock products, 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 fully meet the quality control needs of the whole process in drug research and development, quality research and production.