Salcaprozate

Pulmonary arterial hypertension, as a progressive and fatal cardiovascular disease, has long been plagued by the clinical pain points of limited treatment options and poor patient prognosis. The advent of sacupatril has provided a brand-new pathway for combination therapy in this field. As a prodrug of selective endothelin receptor antagonist, sacupatril can be metabolically activated after entering the body, competitively block the binding of endothelin to its receptors, and inhibit vasoconstriction, smooth muscle proliferation and fibrosis progression. It is mainly used clinically in fixed-dose combination with macitentan for the treatment of adult pulmonary arterial hypertension, which can delay disease progression and reduce the hospitalization risk of patients, especially suitable for the long-term management population with cardiac function grade II-III.

The global market size related to sacupatril is currently in a rapid expansion stage. In 2023, the global sales of related preparations have exceeded 1.2 billion US dollars, with a compound annual growth rate of more than 23%. Due to the clear clinical value of the drug and its relatively new patent protection period, the current market is still dominated by the original research product, with few generic drug layout enterprises. The domestic market is still in the introduction stage. With the improvement of the diagnosis rate of pulmonary arterial hypertension and the gradual expansion of medical insurance coverage, it is expected that the domestic market growth rate will be higher than the global average level in the next 5 years.

The original research enterprise of sacupatril is Janssen Pharmaceuticals under Johnson & Johnson, and the trade name of the original research preparation is "Opsynvi", which is a compound preparation of sacupatril and macitentan. Its core compound patent expires in 2038 in the United States and in 2039 in China. The main dosage form approved by the original research is oral tablet, with the specification of 40 mg sacupatril / 10 mg macitentan. This compound preparation has been included in the FDA Reference Listed Drug Catalog, and has not been included in the Chinese *List of Chemical Drugs* yet. There is no approved registration of sacupatril API in China, nor any related domestic preparation approved for marketing. Only the original research compound preparation submitted a marketing application to the NMPA in 2024, which is currently under the review stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of sacupatril, CATO can provide a full set of impurity reference standards for this API. Most 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 regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use needs of the whole process of drug R&D, quality research and registration declaration.