Triptorelin

In the clinical treatment of hormone-dependent diseases such as prostate cancer, precocious puberty and endometriosis, gonadotropin-releasing hormone (GnRH) agonists are the core category of medications. As a representative variety of this class of drugs, triptorelin continuously stimulates the GnRH receptors in the pituitary gland to periodically inhibit the secretion of luteinizing hormone and follicle-stimulating hormone, and ultimately down-regulates the level of sex hormones to a castration state. Its clinical indications cover metastatic prostate cancer, central precocious puberty, endometriosis, preoperative pretreatment of uterine fibroids, and down-regulation in assisted reproductive technology. The applicable population includes adult tumor patients, gynecological disease patients of childbearing age and children with precocious puberty. The development of long-acting sustained-release dosage forms has greatly improved the medication compliance of patients.

At present, the global market size of triptorelin exceeds 1.8 billion US dollars, with a compound annual growth rate of approximately 4.2% in the past three years. The growth momentum mainly comes from the rising incidence of prostate cancer, the expansion of assisted reproduction demand and the increase in the consultation rate of pediatric precocious puberty. The market size in China exceeds 2.5 billion RMB, with an annual growth rate remaining above 8%. The competitive landscape is characterized by the dominance of the originator drug and the gradual substitution of generic drugs. As of 2024, 3 domestic enterprises have obtained marketing approval for triptorelin microsphere preparations. After the implementation of volume-based procurement, the price of relevant preparations has dropped by more than 70%, which directly drives the continuous rise in the demand for upstream API.

The originator enterprise of triptorelin is Ipsen from France, with the original brand name "Diphereline". Its core compound patent expired around 2015 in major markets such as Europe and the United States, and the compound patent in China also expired in 2015. The main dosage forms approved for the originator drug include triptorelin acetate for injection (common powder for injection, 0.1mg) and triptorelin pamoate microspheres for injection (1-month sustained-release dosage form 3.75mg, 3-month sustained-release dosage form 11.25mg). Relevant preparations have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also listed in the FDA Reference Preparations Catalogue. As of June 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has publicly announced 8 marketing application registration numbers of triptorelin API, among which 6 are in status A (can be used in marketed preparations). 11 triptorelin preparations have been approved for marketing in China, covering common powder for injection and 1-month, 3-month sustained-release microsphere dosage forms. (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 triptorelin API, CATO provides 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. The products comply with multiple regulations including the Chinese Pharmacopoeia and FDA regulations, which can fully meet the full-process needs of API registration and declaration, impurity research, and daily quality testing.