Levomepromazine

In the clinical treatment of mental disorders, drugs with high efficacy and combined sedative and analgesic adjuvant effects have always been an important clinical demand. Levomepromazine is a phenothiazine antipsychotic drug that exerts multiple pharmacological effects by blocking central dopamine D2 receptors, 5-hydroxytryptamine receptors and α-adrenergic receptors. It can be used for the control of positive symptoms of schizophrenia, and also has a good sedative effect on the agitation state of manic episodes. Meanwhile, it can be used as an adjuvant analgesic for moderate to severe pain in patients with advanced cancer, especially suitable for adult patients with anxiety and delirium symptoms. When used in elderly patients, the dosage should be adjusted according to tolerance.

At present, the global phenothiazine antipsychotic drug market maintains steady growth as a whole, and the annual compound growth rate of the subdivided varieties with multiple adjuvant effects is about 4.2%. The market share of levomepromazine is concentrated in Europe and North America, and the domestic market is currently in the layout stage of generic drugs, with no large-scale local production and supply. Clinical medication mainly relies on imports, and the market gap is relatively significant. Due to the unique clinical positioning of this drug, its application scenarios in the field of palliative pain treatment continue to expand, and it is expected to rapidly realize import substitution after the generic drugs are approved for marketing in the future.

The original research enterprise of levomepromazine is Sanofi, and the original research trade name is Levomepromazine. Its core compound patent expired globally in the 1980s. At present, the main dosage forms of the original research product that have been launched include tablets, injections and oral solutions, and the common specifications are 25mg tablets and 25mg/1ml injections. The original research preparation has been included in the reference preparation catalogues of the EU and FDA, and it has not been included in the *Catalogue of Reference Preparations for Chemical Drugs* in China for the time being. As of the retrieval time point, there is no valid registration number of levomepromazine on the CDE API registration platform, and no preparation of this variety has been approved for marketing in China. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for levomepromazine API. Most of the products are in stock. Spot 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 impurity research support for relevant R&D and production enterprises.