Moxonidine

Centrally acting antihypertensive drugs are an important category in the clinical treatment of hypertension. With the in-depth research on the mechanism of sympathetic excitation, new-generation drugs with higher selectivity and milder adverse reactions have gradually become the optimal clinical choice. Moxonidine is a second-generation centrally acting antihypertensive drug, which can highly selectively activate the I1-imidazoline receptor in the rostral ventrolateral medulla, reduce peripheral sympathetic tone, and thus achieve stable blood pressure reduction. Meanwhile, it has extremely low affinity for α2 adrenergic receptors, which greatly reduces the common adverse reactions of first-generation centrally acting antihypertensive drugs such as dry mouth and drowsiness. It is mainly suitable for patients with mild to moderate essential hypertension, especially for people with combined metabolic disorders who cannot tolerate the adverse reactions of other antihypertensive drugs.

The continuous rise in the global prevalence of hypertension drives the expansion of the antihypertensive drug market. Moxonidine occupies a market share in the market segment with its unique mechanism of action. According to public data, in recent years, the global market size related to moxonidine has maintained a steady growth rate of about 3%, and the domestic market size is approximately RMB 120 million. The overall competitive landscape is dominated by generic drugs, with the original research product accounting for less than 10% of the market. More than 10 domestic enterprises have obtained the approval documents for moxonidine preparations, the supply of active pharmaceutical ingredients (APIs) has basically been localized, and there is no record of centralized procurement implementation so far.

The original research enterprise of moxonidine is Boehringer Ingelheim from Germany, with the original brand name Physiotens®. Its core compound patent expired in the European market in 2001, and the core patent in the US market expired in 2003. The main dosage form approved for the original research product is tablet, with specifications including 0.2mg, 0.3mg and 0.4mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations of Chemical Drugs* of China. According to the domestic API registration platform, 6 enterprises have obtained A-status registration numbers for moxonidine APIs so far, and more than 8 other enterprises have obtained marketing approval for moxonidine tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of moxonidine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the needs of various stages including API R&D, quality research and compliance declaration.