Mirogabalin

Central neuropathic pain, as a therapeutic area with long-term unmet clinical needs, has always been a key R&D direction for global pharmaceutical companies due to its complex pathogenesis and high adverse reaction rate of existing drugs. Mirogabalin is a γ-aminobutyric acid (GABA) analog. It exerts analgesic and anticonvulsant effects by highly selectively binding to the α2δ subunit of the presynaptic membrane voltage-dependent calcium channel and reducing the excessive release of excitatory neurotransmitters. Currently, it is mainly used for the treatment of adult patients with neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Compared with similar drugs, it has a lower risk of central side effects and a simpler dosing regimen.

According to publicly verifiable market data, the global market size of neuropathic pain therapeutic drugs has exceeded 15 billion US dollars, among which α2δ ligand drugs account for about 32%. As a new generation of products in this category, mirogabalin has maintained a global market compound annual growth rate of about 11% in the past 3 years. In terms of competitive landscape, the original research product still accounts for more than 70% of the global market share at present, and no domestic generic drug has been approved for marketing in China. As relevant patents expire successively, more than 10 domestic enterprises have laid out the generic drug R&D of this variety, and the market supply side will see significant expansion in the next 3-5 years.

The original research enterprise of mirogabalin is Pfizer, and the original research trade name is Lyrica CR (sustained-release dosage form). Its core compound patent expires in 2023 in the United States, and the compound patent in China expired in 2022. The main dosage form approved by the original research is sustained-release tablets, with common specifications including 82.5mg, 165mg and 330mg. This product has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the Chinese *Catalog of Reference Preparations for Chemical Drugs*. As of the retrieval time point, the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China does not show mirogabalin API that has obtained the A-status registration number, and no mirogabalin-related preparation has been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the needs of generic drug R&D and quality control of mirogabalin, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process from API synthesis process optimization to final product quality research.