Eltrombopag

In response to the treatment needs of hemorrhagic or hematopoietic failure diseases such as chronic immune thrombocytopenia (ITP) and severe aplastic anemia, eltrombopag, as a non-peptide thrombopoietin receptor agonist (TPO-RA), can bind to the TPO receptor on the surface of megakaryocytes across the membrane, activate the JAK-STAT and MAPK signaling pathways, and promote the proliferation and differentiation of megakaryocytes, thereby endogenously increasing the platelet count. Compared with traditional treatment regimens of glucocorticoids and immunosuppressants, eltrombopag has higher convenience of oral administration and lower incidence of adverse reactions. It is suitable for adult/child patients with chronic ITP who have poor response to glucocorticoid or immunoglobulin therapy, or who have undergone splenectomy, as well as patients with severe aplastic anemia in whom immunosuppressive therapy is ineffective. Some of its indications have been extended to the adjuvant treatment of hepatitis C-related thrombocytopenia.

The global market size of eltrombopag has maintained steady growth in recent years, exceeding USD 2.5 billion in 2023. The sales in China's sample hospital market in the first half of 2024 increased by more than 18% year-on-year. At present, the market competition pattern is characterized by the dominance of the original research drug and the gradual penetration of generics. In China, 5 enterprises including Qilu Pharmaceutical and Chia Tai Tianqing have obtained approvals for generic drug preparations. In the provincial centralized procurement in 2023, the average price reduction of eltrombopag oral regular-release dosage forms exceeded 65%. With the increase in the penetration rate of the primary market, the overall domestic market size is expected to maintain a compound annual growth rate of about 12% in the next 3 years.

The original research enterprise of eltrombopag is GlaxoSmithKline, and the original research trade name is Revolade®. Its core compound patent in China expired in 2021, and the preparation patent will expire in 2027. The dosage form approved for the original research drug is tablet, with specifications of 25mg and 50mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also a reference preparation listed by the FDA. In terms of domestic API registration, there are currently 11 registration numbers for eltrombopag olamine API, 8 of which are in A status and can be used for associated review. The domestic approved preparation products include the original research drug and 5 generic drugs, all of which are oral regular-release dosage forms. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for eltrombopag, covering a total of 17 process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can meet the full-process needs of API process research and development, quality research and registration declaration.