Mecamylamine

As a non-selective nicotinic acetylcholine receptor antagonist, mecamylamine is the first ganglion-blocking drug approved in history for the treatment of hypertension. It can block synaptic transmission in autonomic ganglia and simultaneously act on related receptors in the central nervous system to regulate sympathetic tone. Initially, it was mainly clinically used for antihypertensive treatment of moderate to severe hypertension. With the in-depth research in the neuropsychiatric field, its effects on improving nicotine dependence withdrawal and cognitive impairment-related symptoms have been gradually explored. At present, it is also applied in relevant clinical research and rare disease treatment scenarios, providing medication options for patients with special needs.

At present, the global market size of mecamylamine is relatively small, mainly concentrated in the fields of rare disease medication and scientific research medication. The compound annual growth rate of the market in the past five years is about 3.2%, and the overall competitive landscape is highly concentrated. Due to the niche clinical medication demand, only a small number of enterprises around the world have arranged the commercial production of this API. The overseas API supply is mainly concentrated in two pharmaceutical enterprises in North America, and there are less than 3 manufacturers with compliant production capacity in China. It has not been included in the national centralized volume-based procurement scope, and the market supply and demand relationship has remained stable for a long time.

The original research enterprise of mecamylamine is Merck & Co., Inc. in the United States, with the original research trade name Inversine, and the core compound patent expired around 1970. The main dosage form approved by the original research is tablet, with specifications of 2.5mg and 10mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China yet. In the domestic API registration database, there is currently no mecamylamine API with a Class A registration number, and only one enterprise's API registration is under the review and approval stage. No mecamylamine-related preparations have been approved for marketing in China for the time being. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for mecamylamine API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in drug research and development, quality research and registration declaration.