Terlipressin

Hepatorenal syndrome, as a severe complication of decompensated cirrhosis, has an insidious onset and extremely poor prognosis, and there has been a long-term lack of highly specific treatment options in clinical practice. Terlipressin, a synthetic analogue of lysine vasopressin, is a highly selective agonist of the vasopressin V1 receptor. After entering the body, it slowly releases active products through enzymatic cleavage, which can continuously splanchnic blood vessels, reduce portal venous pressure, while reducing renin secretion and improving renal perfusion. At present, this drug is a first-line treatment for type 1 hepatorenal syndrome recommended by global guidelines, and can also be used for emergency hemostasis of esophagogastric variceal bleeding, covering the core treatment needs of patients with critical and severe diseases related to cirrhosis.

At present, the global market size of terlipressin has exceeded 700 million US dollars, with a compound annual growth rate maintained at around 8%. The Chinese market accounts for about 18% and its growth rate is higher than the global average. The domestic market currently presents a pattern of coexistence of original research drugs and generic drugs. Generic preparations from nearly 10 enterprises have passed the consistency evaluation. After being included in the national centralized procurement in 2022, the terminal price has dropped by more than 70%, and the clinical accessibility has been greatly improved, driving the overall drug consumption to increase by more than 200% compared with that before the centralized procurement, and the market demand for active pharmaceutical ingredients has simultaneously entered a stage of rapid release.

The original research enterprise of terlipressin is Ferring Pharmaceuticals, and the original brand name is Glypressin®. The core compound patent expired in Europe and the United States in 2021, and the compound patent in China expired in 2019. The mainstream dosage form approved for the original research drug is injection, with a specification of 1mg lyophilized powder for injection. It has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. Up to now, there are more than 15 registration numbers of terlipressin active pharmaceutical ingredients in China, most of which are in status A (activated and available for associated use), and 8 domestic enterprises have obtained marketing approval for terlipressin injection. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of terlipressin impurity reference standards. Most of the products are available in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises in the whole process of drug R&D, quality research and declaration.