Loxoprofen

Chronic pain and inflammatory diseases are common problems affecting the health of more than 1.5 billion people worldwide. Non-steroidal anti-inflammatory drugs are the core category of clinically used drugs to relieve such symptoms, and loxoprofen is a representative variety of propionic acid drugs among them. As a prodrug, it is converted into active metabolites after absorption through the digestive tract, and reduces the biosynthesis of prostaglandins by inhibiting cyclooxygenase, with triple effects of analgesia, anti-inflammation and antipyresis. Moreover, its incidence of gastrointestinal adverse reactions is lower than that of traditional non-steroidal anti-inflammatory drugs. It is suitable for anti-inflammatory and analgesic treatment of rheumatoid arthritis, osteoarthritis, lumbago, scapulohumeral periarthritis and other diseases, and can also be used for pain relief after surgery, trauma and tooth extraction, as well as antipyretic and analgesic treatment of acute upper respiratory tract inflammation, meeting the medication needs of multiple departments such as adult rheumatology and immunology department, orthopedics department and stomatology department.

The global loxoprofen market size was approximately USD 870 million in 2023, and is expected to maintain a compound annual growth rate of 4.2% from 2024 to 2030. The growth momentum mainly comes from the rising prevalence of osteoarthritis, the expansion of postoperative analgesia demand, and the increasing demand for cost-effective anti-inflammatory and analgesic drugs in the primary market. China is one of the largest consumer markets of loxoprofen. In 2023, the domestic hospital sales exceeded RMB 1.8 billion, and the retail market size outside hospitals exceeded RMB 900 million. At present, the market is dominated by generic drugs, and more than 30 enterprises have obtained preparation approval documents. After the implementation of centralized procurement, the average winning bid price has dropped by more than 60%, further promoting the improvement of clinical penetration, and the upstream API supply has basically achieved domestic substitution.

The original research enterprise of loxoprofen is Sankyo Co., Ltd. of Japan (now Daiichi Sankyo), and the original research trade name is "Loxonin". Its core compound patents in major markets such as Japan and the United States expired around 2010, and the compound patent in China expired in 2009. The main dosage forms approved for the original research include tablets, patches and gel plasters. The conventional specification of oral tablets is 60mg, and the specifications of patches are 50mg/patch and 100mg/patch. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the reference preparation catalogue of the FDA. Up to now, more than 20 loxoprofen API registration numbers have been publicized on the API registration platform of China CDE, among which more than 15 have been approved in A status. Multiple preparation varieties such as tablets, patches and capsules have been approved for marketing in China, which can fully meet the clinical medication demand. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a complete set of impurity reference standards for loxoprofen API, covering all categories such as process impurities and degradation impurities. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities have sufficient stock, and orders placed before 16:00 can be shipped on the same day. It can provide stable and reliable reference substance support for API and preparation enterprises in the links of quality research, consistency evaluation, registration and declaration, etc.