Bixalomer

In response to the unmet clinical needs for refractory hypertension, baxdrostat, a highly selective aldosterone synthase inhibitor, provides a more precise treatment option for clinical practice. This drug belongs to the new generation of mineralocorticoid pathway-related antihypertensive agents. By specifically inhibiting CYP11B2, the key enzyme in the aldosterone synthesis process, it reduces aldosterone production without affecting the normal synthesis of the glucocorticoid cortisol, effectively avoiding the adverse reactions of endocrine disorders caused by non-selective inhibitors. It is clinically mainly used for the treatment of hypertension associated with primary aldosteronism and refractory hypertension, and can also be used in hypertensive patients with concurrent chronic kidney disease and heart failure. It can significantly reduce the risk of cardiovascular events in patients, and the applicable population covers hypertensive patients whose blood pressure is poorly controlled by traditional antihypertensive drugs.

At present, the number of hypertensive patients worldwide has exceeded 1.2 billion, of which approximately 10%-15% have refractory hypertension. The global market size of aldosterone pathway-related indications has exceeded US$8 billion, and the compound annual growth rate from 2023 to 2029 is expected to reach 6.2%. As a first-in-class highly selective aldosterone synthase inhibitor, baxdrostat is currently in the stage of original research monopoly. There are no generic drugs on the market worldwide, and this product has not been approved for import in China. The R&D of domestic innovative pharmaceutical companies on the same target is still in the early stage, and the market gap is relatively large.

The original research enterprise of baxdrostat is Daiichi Sankyo of Japan, and the original brand name is Minnebro. The expiration date of its core compound patent in major global markets is 2033. At present, the main dosage form approved by the original research is tablet, with specifications including 2.5mg, 5mg and 10mg. The original preparation has been approved for marketing in Japan, South Korea and other countries, and has been included in the Japanese Orange Book Reference Preparation Catalogue. Up to now, there is no registration information of baxdrostat API in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and no preparation of this product has been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a complete set of impurity reference standards for baxdrostat API. Most products are available from stock. Spot orders submitted before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the needs of pharmaceutical companies for impurity reference standards in the whole process from R&D to registration.