Safinamide

As a common neurodegenerative disease among middle-aged and elderly people, Parkinson's disease often presents motor complications such as "on-off" phenomenon and dyskinesia when the patient's disease progresses to the middle and late stages. Traditional monoamine oxidase B (MAO-B) inhibitors have limitations of short action duration and high risk of interaction with other drugs. As the third-generation highly selective and reversible MAO-B inhibitor, safinamide has dual dopaminergic and non-dopaminergic mechanisms of action. It can not only reduce dopamine degradation by inhibiting MAO-B and prolong the action time of levodopa, but also block sodium channels, inhibit glutamate release, and have neuroprotective potential. Clinically, it is mainly used as an adjuvant therapy in combination with levodopa for the treatment of adult Parkinson's disease patients with "on-off" fluctuations. It can significantly shorten the duration of "off" period, reduce the severity of dyskinesia during "on" period, and greatly improve the quality of life of patients.

The global market size of safinamide exceeded USD 720 million in 2023, with a compound annual growth rate of 12.8% in the past three years. The core growth drivers are the rising prevalence of Parkinson's disease and the increasing clinical demand for the management of motor complications in patients with advanced Parkinson's disease. At present, the original research product still accounts for nearly 65% of the global market share, and Europe and North America are the core consumer markets. The domestic market is still in the introduction period. With the relevant preparations included in the National Medical Insurance Catalog, the R&D enthusiasm for generic drugs has risen rapidly. Since 2022, 3 domestic enterprises have submitted marketing applications for generic drugs, and the market penetration rate is expected to increase from the current 4.2% to more than 15% in the next 3-5 years.

The original research enterprise of safinamide is Newron Pharmaceuticals, an Italian company, with the original brand name Xadago. Its European compound patent expired in 2022, and the core compound patent in the United States expired in 2023. The approved dosage form of the original research product is tablet, with specifications of 50mg and 100mg. It has been included in the reference preparation catalogs of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and is also included in the *Catalog of Reference Preparations for Chemical Drugs (32nd Batch)* in China. At present, the safinamide APIs of 6 domestic enterprises have obtained A-status registration numbers through the CDE registration platform, which can meet the requirements of associated review for generic drug marketing applications. In addition, 8 domestic safinamide tablets have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for safinamide API. Most of the products are available directly from stock. Stock orders placed before 16:00 can be shipped on the same day. All reference standards comply with multiple regulatory requirements such as Chinese Pharmacopoeia and FDA. The structures of impurities have been strictly confirmed, which can cover the full-process research requirements from API R&D, quality research to generic drug registration and declaration, and provide reliable material basis support for R&D enterprises to shorten the declaration cycle.