Voclosporin

Lupus nephritis is the most common severe complication of systemic lupus erythematosus, and approximately 40% to 60% of patients will progress to chronic kidney disease or even end-stage renal disease. Traditional calcineurin inhibitors have clinical limitations such as nephrotoxicity and narrow therapeutic window. Voclosporin is a new generation of calcineurin inhibitor. Through chemical modification of cyclosporine A, its lipophilicity and tissue distribution characteristics are optimized. While inhibiting calcineurin activity and blocking T cell activation, it can reduce glomerular podocyte injury and proteinuria. It has been approved for the treatment of adult patients with active lupus nephritis, providing a better treatment option for patients who cannot tolerate traditional immunosuppressants.

The global voclosporin market size exceeded USD 900 million in 2023, and the compound annual growth rate is expected to remain at around 18% from 2024 to 2030. The core growth driver comes from the continuous release of treatment demand for lupus nephritis. The current market is still dominated by the original research product. In the Chinese market, only the original research preparation has been approved for marketing, and there is no generic drug application yet. With the further expansion of the population covered by the indication, the domestic demand for the development of related API and generic drugs is gradually increasing.

The original research enterprise of voclosporin is Aurinia Pharmaceuticals, and the original trade name is Lupkynis. Its compound patent in the United States will expire in 2038. The approved dosage form of the original product is oral capsule, with specifications of 7.9 mg and 23.7 mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no voclosporin API has been approved for registration (Status A) in China. Only the original imported preparation was approved for marketing by the National Medical Products Administration in 2022, and no domestic preparation has been approved. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for voclosporin, covering all key impurities in the synthesis pathway and degradation process. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process research needs of pharmaceutical companies from API R&D to marketing application.