Rasagiline

Parkinson's disease is a neurodegenerative disease with a high incidence among middle-aged and elderly populations. With the acceleration of global population aging, symptoms such as bradykinesia and myotonia have brought a heavy disease burden to patients and their families. As a second-generation monoamine oxidase B (MAO-B) inhibitor, rasagiline can highly selectively and irreversibly inhibit the activity of MAO-B, block the catabolism of dopamine, and increase the level of dopamine in the brain. It can be used as monotherapy for early Parkinson's disease, and also as an adjuvant medication to improve the motor fluctuation symptoms of patients with middle and late-stage Parkinson's disease. Its metabolites have no amphetamine-type neurotoxicity, and its safety is significantly better than that of the first-generation selegiline. At present, it has become one of the core medications for the long-term management of Parkinson's disease.

The global rasagiline market size was approximately USD 420 million in 2023, of which the Chinese market accounted for about 12%, with a compound growth rate of 17% in the past three years, which is higher than the global average growth rate. At present, the original research drug still dominates the market. 5 domestic enterprises have obtained the approval documents for generic drugs, and this variety has been included in the seventh batch of national centralized drug procurement. The price of the selected products has dropped by more than 90%, which has greatly improved the clinical accessibility and also driven the continuous expansion of the market demand for upstream API.

The original research enterprise of rasagiline is Teva Pharmaceutical Industries from Israel, and the original brand name is Azilect. The core compound patent of rasagiline expired in the United States in 2017, and the Chinese compound patent expired in 2019. The main dosage form of the original research product is tablet, with a specification of 1mg. It has been listed in the Reference Listed Drug Catalogue of China Marketed Drugs, and is also included in the FDA Reference Preparation Catalogue. At present, the rasagiline APIs of 9 domestic enterprises have completed registration with the status of "A" in CDE, and the rasagiline tablets of another 11 enterprises have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full range of impurity reference standards for rasagiline, covering all reference standards required for the whole set of research such as process impurities and degradation impurities. Most products are in sufficient stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeia regulations of multiple countries including the Chinese Pharmacopoeia and FDA, and can fully support the needs of various stages such as API R&D, quality research and consistency evaluation.