Difamilast

In the field of chronic inflammatory disease treatment, PDE4 inhibitors have become a research and development hotspot in recent years due to their combined anti-inflammatory activity and low risk of systemic side effects. As a new generation of oral selective PDE4 inhibitor, difamilast blocks the release of pro-inflammatory mediators by inhibiting the activity of phosphodiesterase 4, and reduces the expression of inflammation-related cytokines at the same time. It is currently mainly used for the treatment of mild to moderate atopic dermatitis, covering adolescent and adult patient groups aged 12 years and above. Compared with traditional hormone therapy, its safety advantage in long-term use can better meet the needs of patients for chronic disease management.

At present, the global difamilast market is still in the early stage of development. The global market size in 2023 was approximately USD 120 million, and the compound annual growth rate from 2024 to 2030 is expected to remain above 28%. The growth momentum mainly comes from the continuous rise in the prevalence of atopic dermatitis, as well as its future potential to expand indications such as psoriasis and allergic rhinitis. The current competitive landscape is dominated by the original research enterprise, and there are few enterprises laying out generic drugs on a global scale. In China, only a small number of pharmaceutical companies have launched generic drug R&D pipelines, and no generic products have been approved for marketing yet, leaving a relatively high market gap.

The original research enterprise of difamilast is Astellas Pharma Inc. of Japan, and the original brand name is Molgard. Its core compound patent expires in 2033 in Japan, and the compound patents in the US and Chinese markets both expire in 2034. The main currently approved dosage form is oral tablet, with specifications of 10mg and 20mg, which has been included in the reference preparation catalogs of Japan and the US FDA. Up to now, no valid registration number of difamilast active pharmaceutical ingredient has been found in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and no preparation product of this variety has been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of this variety, CATO provides a full set of difamilast impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA at the same time, providing stable and reliable reference standard support for pharmaceutical enterprises in impurity research, quality standard establishment and generic drug declaration.