Tetracosactide

As a chronic endocrine disease, adrenocortical insufficiency requires patients to receive long-term hormone replacement therapy to maintain normal physiological functions. The advent of tetracosactide provides a more accurate treatment option for clinical practice. As a synthetic adrenocorticotropic hormone analogue, it can stimulate the synthesis and secretion of hormones such as cortisol and aldosterone by binding to ACTH receptors on the adrenal cortical cell membrane. Compared with natural adrenocorticotropic hormone, it has a longer half-life and lower immunogenicity. In clinical practice, it is mainly used for replacement therapy of adrenocortical insufficiency, diagnostic screening of adrenocortical function, and adjuvant treatment of some autoimmune diseases and inflammatory diseases, covering both adult and pediatric patient groups.

The global tetracosactide market scale maintains a steady growth trend. In 2023, the market scale was approximately USD 320 million, with a compound annual growth rate maintained at around 4.7%. The core drivers of market demand come from the year-on-year increase in the prevalence of adrenocortical insufficiency and the improvement of clinical safety requirements for hormone replacement therapy drugs. The current market is dominated by original research products, with Europe and North America being the major consumer markets, accounting for 72% of the total global demand. The domestic market is still in the stage of import dependence, with few enterprises developing generic drugs. With the advancement of domestic rare disease drug security policies, there is a large space for domestic substitution in the future market.

The original research enterprise of tetracosactide is Ferring Pharmaceuticals, and the original trade name is Synacthen®. Its core compound patents in major markets such as Europe and the United States expired around 2000, and the compound patent in China has also expired. The mainstream dosage forms of the original research product include injection and sustained-release injection, with specifications covering 0.25mg/1ml, 1mg/1ml, etc. The original preparation has been included in the FDA Reference Listed Drug Catalogue, but has not yet been included in the *Catalogue of Chemical Drugs* of China. There is no publicly available A-status tetracosactide API registration number on the domestic API registration platform for the time being. The only preparation approved for marketing in China is the original imported tetracosactide for injection, and no domestic preparation has been approved yet. (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 tetracosactide API, covering reference standards required for the whole research path including synthesis process impurities and degradation impurities. 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 compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support enterprises' full-process needs of API research and development, quality research and registration declaration.