Selegiline

As a common neurodegenerative disease among middle-aged and elderly people, Parkinson's disease is currently mainly treated with dopamine replacement regimens, while the advent of selegiline provides a new path for delaying disease progression and optimizing medication combinations. As a selective irreversible monoamine oxidase type B (MAO-B) inhibitor, it can prolong the action time of dopamine by inhibiting dopamine metabolism and reducing the reuptake of dopamine by the presynaptic membrane. It can be used as a single drug for patients with early Parkinson's disease to improve motor symptoms and delay the initiation time of levodopa, and can also be combined with levodopa for patients with middle and advanced stages to reduce the incidence of dyskinesia and "on-off phenomenon". Meanwhile, it also has certain clinical exploration value for the adjuvant treatment of Alzheimer's disease and depression.

The global selegiline market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 320 million, with a compound annual growth rate of around 4.7%. The growth drivers mainly come from the year-on-year increase in the prevalence of Parkinson's disease and the popularization of combination medication regimens. In terms of the domestic market, more than 10 enterprises have been approved to produce selegiline preparations at present, with generic drugs accounting for more than 90%. In addition, this variety has been included in the third batch of national centralized drug procurement, and the price of winning bids has dropped by more than 80%, which has greatly improved clinical accessibility and also driven the continuous rise in demand for upstream API.

The original research enterprise of selegiline is Orion Corporation of Finland, with the original trade name "Eldepryl". Its core compound patent expired globally in 1998. The main dosage form of the original research product is tablet with a specification of 5mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a designated reference preparation included by the FDA. In terms of domestic API registration, 6 enterprises have obtained CDE registration numbers (status A) for selegiline API at present. The domestically approved preparation varieties cover two dosage forms: tablets and orally disintegrating tablets, with sufficient clinical supply. (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 selegiline API. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can fully meet the experimental needs of the whole process including API R&D, quality research, compliance declaration, etc.