Trilostane

There are long-standing unmet clinical needs for diseases related to abnormal adrenal cortex function, and in particular, the options of drug therapy for Cushing's syndrome have been limited for a long time. Trilostane is an adrenal corticosteroid synthesis inhibitor. It competitively inhibits 3β-hydroxysteroid dehydrogenase and blocks the conversion of pregnenolone to progesterone, thereby reducing the synthesis of steroid hormones such as cortisol and aldosterone. Clinically, it is mainly used for the treatment of Cushing's syndrome (hypercortisolism), and can also be used as an adjuvant therapy for preoperative control of primary aldosteronism. Its applicable population covers adults and some adolescent patients with Cushing's syndrome who meet the medication indications. It can help patients relieve a series of symptoms caused by excessive hormones, such as central obesity, hypertension and metabolic disorders, and reduce the risk of long-term complications of the disease.

The current global market size of trilostane is approximately USD 120 million, with a compound annual growth rate of 8.7% in the past three years. The growth momentum mainly comes from the improvement of the diagnosis rate of rare diseases and the elevation of the first-line recommendation level of this drug in clinical medication guidelines. The competitive landscape is relatively concentrated. The original research product accounts for more than 65% of the global market share, and the suppliers of generic drugs are mainly pharmaceutical enterprises in India and Europe. The domestic market is still in the introduction stage at present, and no domestic generic drug has been approved for marketing, so clinical medication is highly dependent on import channels.

The original research enterprise of trilostane is Biotique, a UK-based company, and the brand name of the original research product is Modrenal. The core compound patent expired globally in 2004. The currently approved dosage form of the original research product is oral capsule, with two specifications of 30mg and 60mg. It has been included in the FDA Reference Listed Drug Catalog, and this product is also included in the *Catalog of Reference Preparations for Chemical Drugs* issued by China's NMPA. Up to now, there is no valid registration number of trilostane API on China's CDE API registration platform, and no preparation of this product has been approved for marketing in China. Clinical medication is mainly supplied through the special import channel for rare diseases. (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 trilostane API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. They can provide stable reference standard support for the generic drug R&D and quality research of relevant pharmaceutical enterprises, help shorten the R&D cycle, and ensure the accuracy and compliance of research data.