Vorinostat

Cutaneous T-cell lymphoma is a rare subtype of non-Hodgkin's lymphoma. The response rate of traditional chemotherapy regimens in patients with relapsed and refractory disease is less than 30%, and there has been a long-term unmet clinical need for treatment. Vorinostat is the world's first approved histone deacetylase inhibitor. By regulating the level of histone acetylation, it induces differentiation and apoptosis of tumor cells and inhibits their proliferation. It is mainly used for the treatment of progressive, persistent or recurrent cutaneous T-cell lymphoma, and is indicated for adult patients who have failed two systemic drug therapies, opening up a new path of epigenetic targeted therapy in the field of this rare disease.

The global vorinostat market size was approximately USD 120 million in 2023. Driven by the increased diagnosis rate of rare diseases and the improved accessibility of drugs in emerging markets, the compound annual growth rate from 2024 to 2030 is expected to remain at around 4.7%. At present, the market is still dominated by the original research product. No local enterprise in China has obtained the production approval for the API and preparation of vorinostat, and only a small number of enterprises have submitted clinical trial applications. The market is in a stage of insufficient development, and the gap between potential clinical demand and supply is relatively prominent.

The original research enterprise of vorinostat is Merck Sharp & Dohme, with the original brand name Zolinza. Its core compound patent in the United States expired in 2022, and its compound patent in China was terminated in 2020 due to unpaid annual fees. The main dosage form approved for the original product is capsule, with a specification of 100 mg. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* of China. As of now, the Center for Drug Evaluation of the National Medical Products Administration of China has no approved API registration number for vorinostat, nor has any preparation of this variety been approved for marketing. (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 vorinostat. Most products are in sufficient stock. Spot orders submitted 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 can provide stable compliance support for relevant pharmaceutical enterprises in API R&D, quality research and registration declaration.