Crisaborole

Atopic dermatitis is a chronic inflammatory skin disease, with more than 200 million patients worldwide, among which pediatric patients account for nearly 40%. For a long time, topical treatment options have been mostly limited to glucocorticoids and calcineurin inhibitors, and there is a clinical pain point that the safety of long-term use is limited. Crisaborole is a non-steroidal topical anti-inflammatory drug belonging to the phosphodiesterase 4 (PDE4) inhibitor class. It reduces the release of pro-inflammatory cytokines by inhibiting the activity of PDE4, and can directly exert anti-inflammatory effects without in vivo metabolism. It is mainly used for the local treatment of patients with mild to moderate atopic dermatitis aged 2 years and above, providing a brand-new non-hormonal option for long-term maintenance treatment in clinical practice.

Public data show that the global market size related to crisaborole exceeded 1.2 billion US dollars in 2023, with a compound annual growth rate of around 18% in the past three years. The growth rate of the Chinese market is significantly higher than the global average, with a year-on-year growth rate of 47% in 2023. At present, the original research product still occupies the main market share in the domestic market. Generic drug preparations from 3 domestic enterprises have been approved for marketing, and the APIs and generic drugs of more than 10 other enterprises are in the declaration stage. With the gradual expansion of the coverage of centralized procurement, the accessibility of the product is expected to be further improved.

The original research enterprise of crisaborole is Amgen Inc. in the United States, and the original research trade name is Eucrisa®. Its core compound patent in the United States expires in 2025, and the compound patent in China expires in 2026. The dosage form approved for the original research is ointment, with a specification of 2% (30g:0.6g/piece, 60g:1.2g/piece). It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has publicly announced more than 10 registration information of crisaborole APIs, among which the registration status of multiple enterprises is "A", which can be legally supplied for the production and use of marketed preparations. There are already 5 generic crisaborole ointments approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for crisaborole API, covering all categories such as process impurities and degradation impurities. Most of the products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the R&D and production needs of API and preparation enterprises in the whole process including quality research, consistency evaluation, registration and declaration, etc.