Pimavanserin

The clinical treatment of Parkinson's disease with psychiatric disorders has long been in a dilemma. Traditional antipsychotic drugs tend to aggravate extrapyramidal symptoms, and the choice of clinical medication is extremely limited. Pimavanserin, as the world's first selective 5-hydroxytryptamine 2A (5-HT2A) receptor inverse agonist, targets the 5-HT2A receptor with high selectivity and does not bind to dopaminergic, adrenergic, histaminergic and other receptors. Without affecting motor function, it can effectively relieve psychiatric symptoms such as hallucinations and delusions in patients with Parkinson's disease. At present, it has been recommended as the first-choice treatment for psychiatric symptoms of Parkinson's disease by a number of international clinical guidelines. It is suitable for the treatment of psychotic symptoms in adult patients with Parkinson's disease, providing a safer option for medication in special populations.

At present, the global pimavanserin market is in a stage of steady growth. According to public data, its global sales in 2022 were approximately US$830 million, with a compound annual growth rate maintained at around 12%. With the year-on-year increase in the global prevalence of Parkinson's disease and the improvement of clinical attention to psychiatric symptoms, its market size still has considerable room for expansion. In terms of the competitive landscape, the original research product still occupies a dominant position at present. Only a small number of pharmaceutical companies around the world have arranged generic drug research and development, and no generic drug has been approved for marketing in China so far, with a relatively high market access threshold.

The original research enterprise of pimavanserin is ACADIA Pharmaceuticals, and the original brand name is Nuplazid. Its core compound patent in the United States expires in 2030, and the compound patent in China expires in 2027. The main dosage form approved for the original research product is tablet with a specification of 17mg, which has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Catalog of Chemical Drugs* in China. As of the retrieval time point, there is no valid registration number of pimavanserin on the domestic CDE API registration platform, and no preparation of this variety has been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of pimavanserin impurity reference standards, which fully meet the reference standard needs of pharmaceutical enterprises in various stages of API research and development, quality research and registration declaration. Most products are available from stock, and spot inventory supports same-day delivery for orders placed before 16:00. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Complete technical documents such as structure confirmation and purity calibration can be provided simultaneously, helping customers efficiently promote the project research and development process.