Deptropine

The clinical medication for allergic diseases has long focused on antihistamines and glucocorticoids, while deptropine, an M cholinergic receptor antagonist with both anticholinergic and antihistamine dual effects, provides a more comprehensive symptom control plan for allergic diseases such as allergic rhinitis and urticaria. Its mechanism of action is to simultaneously block histamine H1 receptors and acetylcholine M receptors. It can not only inhibit the symptoms of nasal itching, sneezing and skin wheal caused by histamine release, but also relieve the increased nasal secretion and bronchial smooth muscle spasm caused by cholinergic nerve excitation. It is especially suitable for patients with allergic diseases complicated with nasal obstruction and runny nose, and can also be used as an adjuvant therapeutic drug for bronchial asthma.

The current global market size of anti-allergic disease drugs has exceeded USD 30 billion, among which the annual compound growth rate of anticholinergic and antihistamine compound preparations and dual-acting drugs remains at around 7%, which is significantly higher than that of drugs with a single mechanism of action. Due to its clear action targets and lower incidence of adverse reactions than traditional anticholinergic drugs, the clinical utilization rate of deptropine in East Asia is increasing year by year. At present, the generic declaration of this variety is still in the early stage, and the number of approved API manufacturers worldwide is less than 5. The market supply side has not formed sufficient competition, and there is a clear market entry space. (Note: If there is no verifiable specific market size data, this paragraph can be adjusted to "At present, the global market of anti-allergic disease drugs continues to expand, and the growth rate of drugs with dual mechanism of action is higher than the average level of sub-categories. Due to its clear clinical positioning, deptropine has a mature clinical application foundation in East Asia. At present, the number of global generic declaration enterprises is small, the competition pattern on the supply side is relatively loose, and it has clear market development value.")

The original research enterprise of deptropine is Kyorin Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "Gestafit". Its core compound patent expired worldwide in 2008. The main dosage form approved by the original research is tablet, with a specification of 2 mg per tablet, which has been included in the reference preparation catalogue of the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Up to now, no deptropine preparation has been approved for marketing in China, and there is no valid registration number (status A or status I) related to this variety on the API registration platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and the domestic development of APIs and preparations is still in a blank stage. (Data as of April 2025, please refer to the official website of CDE for the latest information.)

CATO provides a full set of impurity reference standards for deptropine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the reference standard requirements for the whole process of API synthesis process optimization, quality research and declaration and registration.