Demiditraz

For the clinical treatment of relapsed or refractory peripheral T-cell lymphoma, the advent of highly selective targeted drugs has significantly improved the survival prognosis of patients. Demitrostat is an oral antitumor drug belonging to the XPO1 (exportin 1) inhibitor class. By specifically blocking the XPO1-mediated nuclear export process of tumor suppressor proteins and growth regulatory proteins, it promotes the retention of relevant proteins in the nucleus and restores their tumor suppressor functions, while inducing apoptosis of tumor cells. Currently, it is clinically mainly used for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma, providing a new later-line treatment option for populations who have experienced disease progression after receiving at least one prior line of systemic therapy.

At present, the global market size of XPO1 inhibitors has exceeded 1.2 billion US dollars, with a compound annual growth rate remaining above 21%, among which drugs for the indication of peripheral T-cell lymphoma account for approximately 18%. As the first XPO1 inhibitor approved globally for T-cell lymphoma, the original research product of demitrostat currently occupies the major global market share. There are no generic drugs approved for marketing in China, and the overall market is in the initial stage of just entering the commercialization phase. With the further expansion of clinical evidence for indications, there is considerable market growth space.

The original research enterprise of demitrostat is Karyopharm Therapeutics, with the original brand name Xpovio. The expiration date of its core compound patent in the United States is 2038, and the expiration date of the compound patent in China is 2037. The dosage form of the original research product already on the market is tablets, with two specifications including 20 mg and 80 mg. The original research tablets have been included in the FDA Reference Listed Drug Catalog, and have not yet been included in the China List of Chemical Drugs. As of the retrieval time point, there is no approved registration number for demitrostat active pharmaceutical ingredient, nor any relevant preparation product approved for marketing in China. (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 demitrostat. Most products support spot supply. For spot orders paid before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in the stages of active pharmaceutical ingredient research and development, quality research and declaration.