Mianserin

In the whole-course management of depression, drugs with both anti-anxiety effects and high cardiovascular safety have always been an important clinical demand. Mianserin belongs to the tetracyclic antidepressants, and its mechanism of action is different from that of traditional tricyclic drugs. It enhances the release of norepinephrine by blocking the α2 adrenoceptors on the presynaptic membrane of central synapses, and meanwhile has a certain antagonistic effect on 5-hydroxytryptamine receptors, with both sedative and anti-anxiety effects. It is mainly used clinically to treat various types of depression, especially depressive patients with insomnia and anxiety symptoms, and can also be used for patients with primary anxiety disorder and physical diseases accompanied by depression. Due to its extremely low affinity for cholinergic receptors, the incidence of anticholinergic adverse reactions is low, so it is more suitable for elderly patients and depressed people with underlying cardiovascular diseases.

At present, the global market size of antidepressants has exceeded 15 billion US dollars, among which non-tricyclic antidepressants account for more than 90%. As a mature product with more than 40 years of clinical application, mianserin has a global market size of approximately 120 million US dollars, with a compound annual growth rate of about 2.8% in the past 3 years, and the growth mainly comes from the release of demand in the primary mental health diagnosis and treatment market. In China, the market size of mianserin preparations is approximately 180 million RMB, among which imported preparations account for about 62%, and the proportion of domestic generic preparations is increasing year by year. At present, 3 domestic enterprises have obtained preparation approvals, the supply of API has basically realized domestic substitution, and there is no record of national centralized procurement yet.

The original research enterprise of mianserin is Organon, and the original research trade name is "Bolvidon". Its core compound patent expired globally in 1996, and there is no core patent restriction at present. The main dosage form of the original research product is tablet, with core specifications of 10mg and 30mg. The 30mg specification has been included in the China Listed Medicines Catalog as the reference preparation, and is also included in the FDA Reference Preparation Catalog. In terms of domestic API registration, 6 enterprises have completed CDE registration of mianserin API with the status of A (already used in marketed preparations); multiple specifications of domestic mianserin tablets have been approved for marketing, and the original imported tablets have ceased to be sold in China at present. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for mianserin API. All impurities have undergone complete structure confirmation, meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and most products are available from stock. Spot orders paid before 16:00 can be dispatched on the same day, which can fully meet the various needs of drug R&D, quality research and routine release testing.