Crisaborole is Reshaping Atopic Dermatitis Treatment, Backed by SZEB Quality Control Support​

As autumn and winter approach, accelerated skin moisture loss often leads to a high incidence of atopic dermatitis (AD). Atopic dermatitis is a common chronic, inflammatory skin .

A key feature of crisaborole is that it is hormone-free, meaning it does not cause side effects related to hormonal treatments. This characteristic addresses safety concerns associated with the long-term use of hormonal drugs in traditional AD therapies.

The originator drug, Eucrisa (crisaborole ointment), was developed by Anacor Pharmaceuticals. Following the acquisition of Anacor by Pfizer in 2016, the rights to the originator patent were transferred to Pfizer . In July 2020, crisaborole ointment was approved in China through a clinical urgent approval pathway for the treatment of mild to moderate atopic dermatitis in patients aged 2 and above. It was included in the National Reimbursement Drug List (NRDL) in 2021 . In August 2023, the indication for crisaborole ointment was expanded, lowering the applicable age from 2 years and above to include patients as young as 3 months old . This expansion reflects the well-established safety profile of crisaborole in clinical applications.

According to the NMPA website, Wanrong Jiancheng‘s crisaborole ointment received a supplementary application approval on September 26, making it the first generic version in China On October 9, Jincheng Pharmaceutical‘s crisaborole active pharmaceutical ingredient (API) was officially approved for marketing, indicating that domestic crisaborole medications are expected to gradually enter the market .

During the research, development, and production of crisaborole, the generation of specific impurities is inevitable. The analysis and study of these impurities are crucial for efficient pharmaceutical development and regulatory submissions .

SZEB  specializes in supplying crisaborole impurity reference standards. For more information on a wide range of selected impurities, visit the official website: www.ex-biotech.com .Contact us by e-mail:sales@ex-biotech.com .