Gonadorelin

The functional regulation of the hypothalamic-pituitary-gonadal axis is the core direction for the treatment of reproductive endocrine diseases. As a synthetic decapeptide gonadotropin-releasing hormone (GnRH) analog, gonadorelin can mimic the secretion rhythm of endogenous GnRH through pulsed administration, stimulate the pituitary gland to synthesize and release luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby regulating gonadal function. It is clinically mainly used for the diagnosis of hypothalamic-pituitary-gonadal dysfunction, and the treatment of primary amenorrhea, hypothalamic infertility, cryptorchidism, prostate cancer and other diseases, covering patient groups in multiple departments such as reproductive department, pediatrics and oncology, and is a classic reference drug in the field of precise endocrine regulation.

The global market size of gonadorelin-related preparations is approximately USD 230 million, and the annual growth rate of the Chinese market remains at around 8%, with demand mainly coming from the fields of infertility diagnosis and treatment, and the treatment of children with abnormal sexual development. At present, the domestic market has a coexistence of original research and generic preparations. After the coverage of centralized procurement, the terminal price has dropped by more than 60%, and the demand of downstream preparation enterprises for cost-effective and compliant APIs continues to rise. The API supply side presents a pattern of joint competition between leading European enterprises and domestic characteristic generic pharmaceutical enterprises.

The original research enterprise of gonadorelin is Ferring Pharmaceuticals, with the original research trade name Factrel. The core compound patent expired globally in 1990, and there is no core patent restriction under research at present. The main dosage form of the original research product is injection, with conventional specifications including 100μg/vial and 500μg/vial. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the China Listed Drug Catalog. As of now, the domestic CDE API Registration Platform has publicized 6 gonadorelin API registration information, of which 3 are in Status A and can be associated with the declaration and marketing of preparations. A number of domestic enterprises have obtained marketing approval for gonadorelin injection. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for gonadorelin, most of which 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, providing stable reference standard support for API R&D, quality research and consistency evaluation.