Pridinol

For dyskinesia diseases caused by central muscle spasm, there has been a long-term lack of clinical treatment options that take both antispasmodic effect and peripheral safety into account, and the advent of pridinol has filled this clinical gap. As a central anticholinergic muscle relaxant, it reduces skeletal muscle tension by inhibiting the brainstem reticular structure and spinal reflex pathways, while also having mild analgesic and antihistamine effects. At present, it is mainly used to treat muscle tension-related diseases such as low back pain, neck-shoulder syndrome, and scapulohumeral periarthritis, and can also be used for spastic paralysis caused by central diseases such as cerebrovascular accident and spinal cord injury. The applicable population covers young and middle-aged patients with strain and elderly patients with neurodegenerative diseases accompanied by spastic symptoms.

The current global pridinol market size is approximately USD 230 million, with a compound annual growth rate maintained at around 4.2%. The growth momentum mainly comes from the rising prevalence of chronic musculoskeletal diseases and the expansion of rehabilitation demand after central nervous system injury. The Chinese market is still in the early stage of development, with an current annual sales volume of approximately RMB 120 million, and the growth rate is higher than the global average, reaching 7.8%; the competition landscape is dominated by generic drugs, with the original research product accounting for less than 15% of the market. The API supply of domestic enterprises has gradually realized independent substitution, and there is no record of winning the bid in centralized procurement, so there is still large room for market expansion.

The original research enterprise of pridinol is Sumitomo Pharma of Japan, with the original trade name "Mydocalm", and its core compound patent expired globally in 2008. The main dosage forms approved for the original research product include tablets and injections, with the tablet specification of 50mg and the injection specification of 2ml:20mg. They have been listed in the Japanese Orange Book and the FDA Reference Listed Drug Catalog, and are also included in the *Catalogue of Reference Preparations for Chemical Drugs (9th Batch)* of China. In terms of domestic API registration, there are currently 3 enterprises whose pridinol APIs have passed the CDE registration and publicity (A status), and another 5 enterprises are in the review and approval stage; at the preparation level, multiple domestic enterprises have obtained marketing approval for pridinol tablets, while no injection has been approved. (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 pridinol API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard support for API and preparation enterprises in the whole process of R&D, registration and production, fully meeting the relevant requirements of consistency evaluation and daily quality control.