Cabergoline

There are long-standing unmet clinical needs for endocrine and nervous system diseases such as Parkinson's disease and hyperprolactinemia. The advent of long-acting dopamine receptor agonists provides a better option for the long-term management of these diseases. Cabergoline is a highly selective agonist of dopamine D2 receptors belonging to the ergot derivative class. By exerting a long-lasting effect on dopamine D2 receptors in the anterior pituitary gland, it potently inhibits prolactin secretion, and at the same time improves dopaminergic nerve conduction in patients with Parkinson's disease. In clinical practice, in addition to being the first-line long-term therapeutic agent for hyperprolactinemia, it can also be used for adjuvant treatment of Parkinson's disease, breast cancer-related endocrine regulation, and clinical intervention for postpartum milk return. Its applicable population covers endocrine disease patients of childbearing age to elderly patients with neurodegenerative diseases. Due to the advantages of long half-life and low administration frequency, it greatly improves patients' medication compliance.

The global cabergoline market size was approximately USD 480 million in 2023, and it is expected to grow at a compound annual growth rate of 4.2% to USD 590 million by 2028. The growth drivers mainly come from the increased diagnostic rate of hyperprolactinemia, the expansion of the Parkinson's disease patient population, and the improvement of drug accessibility in emerging markets. The current market pattern is characterized by the originator drug occupying the high-end market and generic drugs gradually increasing in volume. The penetration rate of generic drugs in European and American markets has exceeded 60%, while the domestic market in China is still dominated by originator products at present, with a small number of generic drug application enterprises and no inclusion in the national centralized drug procurement catalog. The overall market competition is relatively mild, and there is sufficient space for the development of active pharmaceutical ingredients (APIs) and generic drugs.

The originator enterprise of cabergoline is Pfizer, with the original trade names Cabaser/dostinex. The core compound patent expired in 2005 in major European and American markets, and the compound patent in China has also expired. The main dosage form approved for the originator drug is tablet, with conventional specifications including 0.25mg and 0.5mg, which have been included in the FDA Reference Listed Drug Catalog and China's Catalog of Reference Preparations for Chemical Drugs. As of now, there is no domestically produced cabergoline preparation approved for marketing in China, and no enterprise has submitted a cabergoline API registration number on the CDE API registration platform. Domestic clinical use completely relies on imported originator preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for cabergoline API. Most products are available from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various reference standard needs in the stages of API research and development, quality research and registration.