Loxapine

As a chronic and severe mental disorder, the control of positive symptoms and the improvement of negative symptoms of schizophrenia have always been the core demands of clinical medication. Loxapine is a first-generation antipsychotic of the dibenzoxazepine class, which exerts its effect by blocking central dopamine D2 receptors and 5-hydroxytryptamine 2A receptors. Compared with traditional phenothiazine drugs, it has relatively mild sedative effect and lower incidence of extrapyramidal adverse reactions. It is not only suitable for the control of positive symptoms such as agitation, hallucinations and delusions in acute schizophrenia, but also can be used for the maintenance treatment of chronic schizophrenia. Some studies have shown that its improvement effect on negative symptoms is better than that of some typical antipsychotics, covering the full course treatment needs of adult schizophrenia.

In the global antipsychotic drug market, loxapine occupies a stable share in primary mental disease diagnosis and treatment scenarios by virtue of its high cost performance. In 2023, the global market size of loxapine preparations was approximately USD 120 million, of which generic drugs accounted for more than 85%. In terms of the Chinese market, with the gradual improvement of the mental health service network, loxapine, as a Class B variety in the medical insurance catalogue, has achieved an annual compound growth rate of 8.2% in hospital drug consumption in the past three years. At present, the domestic preparation market is dominated by generic drugs, and no original research products are sold yet. The supply of APIs is mainly concentrated in several domestic pharmaceutical enterprises that have passed GMP certification.

The original research enterprise of loxapine is Novartis, with the original brand name Loxitane. Its US compound patent expired in 1990, and all core preparation patents expired before 2000. The main dosage forms approved by the original research include tablets (5mg, 10mg, 25mg, 50mg) and powder for inhalation. The original research tablets have been included in the FDA Reference Listed Drug Catalogue, but are not included in the Chinese Reference Listed Drug Catalogue at present. As of the time of retrieval, there are 4 loxapine API registration entries on the API registration platform of China CDE, among which 3 have obtained A status through joint review and approval with preparations. A number of domestic pharmaceutical enterprises have obtained marketing approval for loxapine tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for loxapine API, which fully covers intermediates, by-products and degradation impurities that may be generated during the synthesis process, and meets the quality requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day, fully meeting the timeliness requirements of pharmaceutical enterprises in R&D and quality control links.