Meptazinol

The clinical selection of opioid analgesics has long faced the challenge of balancing the risk of addiction and analgesic efficacy. Meptazinol, as a new generation of mixed opioid receptor agonist-antagonist, exerts analgesic effect by activating κ receptors and partially antagonizing μ receptors. Its analgesic potency is 1/3 to 1/2 that of morphine, and its adverse reactions such as respiratory depression and addiction are significantly lower than those of pure opioid receptor agonists. It is mainly used clinically to relieve moderate to severe postoperative pain, obstetric labor pain and chronic cancer pain. It is suitable for adult patients who have poor tolerance to pure opioids or are at risk of drug abuse, and can also be used as a component of multimodal analgesia regimens to reduce the total dosage of opioids.

The global postoperative analgesia market size has exceeded 13 billion US dollars, and the annual growth rate of mixed opioids remains at around 8%, which is much higher than the average growth rate of 3% for traditional opioids. At present, the meptazinol market is dominated by the original research product, with Europe and Japan as the major consumer markets. In China, it is still in the early stage of clinical promotion, and there is no publicly available accurate market size data.

The original research enterprise of meptazinol is Kyowa Kirin in the United Kingdom, and its original brand name is **Meptid**. The core compound patents of the drug in major markets such as Europe and the United States expired around 2000, and the compound patent in China was not authorized. The main dosage forms of the original marketed product include 100mg oral tablets and 100mg/2ml injection. The injection has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* in China. Up to now, no meptazinol API has obtained the A-status registration number in China, no domestic meptazinol preparation has been approved for marketing, and no imported preparation has entered the Chinese market. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of meptazinol impurity reference standards, which fully cover impurities generated during synthesis, degradation impurities and isomer impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of enterprises in the whole process of API R&D, quality research and registration declaration.