Flupirtine

In response to the clinical pain points that long-term use of non-steroidal anti-inflammatory drugs in patients with chronic pain is prone to cause gastrointestinal irritation and opioids carry addiction risks, flupirtine, as a non-opioid, non-steroidal central analgesic, provides a safer option for pain management. It selectively opens neuronal potassium channels, stabilizes cell membrane potential, inhibits the conduction and amplification of pain signals, and also has certain muscle relaxation and neuroprotective effects. Clinically, it is mainly used for acute mild to moderate pain, such as postoperative pain, traumatic pain, musculoskeletal system pain, etc., and is especially suitable for pain populations who cannot tolerate non-steroidal anti-inflammatory drugs or opioids. Its characteristics of no addiction and no respiratory depression give it significant application advantages in the elderly pain patient group.

At present, the global flupirtine market size is about USD 120 million. Driven by the rising prevalence of chronic pain and the growing clinical demand for low-risk analgesics, the compound annual growth rate in the past 3 years has maintained at around 4.2%. In terms of the domestic market, flupirtine has not been included in the national centralized volume-based procurement, and the overall competitive landscape is relatively loose. At the current stage, preparation supply is dominated by imported original research products and a small number of domestic generic drug manufacturers, the supply gap of APIs is relatively obvious, and there is no public verifiable data on the segmented market size.

The original research enterprise of flupirtine is AWD.pharma GmbH, Germany, and the original trade name is "Katadolon". Its core compound patent expired in Europe in 2002, and the Chinese compound patent also expired in 2004. The main dosage form approved for the original drug is capsules with a specification of 100mg. This dosage form has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. In terms of domestic API registration, as of now, a total of 3 enterprises have obtained A-status registration numbers for flupirtine APIs after passing the CDE evaluation and publicity, and another 4 enterprises have registration applications under evaluation; at the preparation level, the original imported capsules, as well as capsules and suppositories of multiple domestic generic drugs have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of flupirtine impurity reference standards, covering a full range of research reference materials including synthetic process impurities, degradation impurities, etc. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA, and can directly support API registration and declaration and quality research work. Most of the impurity reference standards on the platform are kept in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, effectively shortening the quality control cycle in R&D and production links.