Zuranolone

Perioperative anxiety and postoperative delirium are unmet clinical needs in clinical anesthesia and perioperative management, especially in elderly surgical patients, as related adverse reactions can significantly prolong the length of hospital stay and increase the risk of postoperative adverse events. Zuranolone, as a new generation of highly selective positive allosteric modulator of GABAA receptor, is a short-acting sedative-hypnotic active pharmaceutical ingredient. By targeting the α2/α3 subunits of GABAA receptor, it exerts rapid sedative and anxiolytic effects while greatly reducing the risk of adverse reactions such as respiratory depression and cognitive impairment that are common with traditional benzodiazepines. At present, the indications under clinical development mainly include perioperative sedation, preoperative anxiolysis, and moderate sedation during outpatient diagnosis and treatment procedures, and the applicable population covers adult patients undergoing elective surgery and subjects requiring short-term sedation during diagnosis and treatment procedures.

Currently, zuranolone is still in the clinical development stage globally, and there is no market size data related to commercial sales. More than 10 domestic pharmaceutical companies have laid out the R&D of its API and preparations, with indications focusing on the field of perioperative sedation. With the steady growth of domestic surgical volume and the increasing clinical demand for safer sedative drugs, if this product is successfully launched, it is expected to fill the gap in the market segment, and the competitive landscape will revolve around R&D progress, preparation process optimization and cost control.

Zuranolone was jointly developed by Theravance Biopharma in the US and Merck Sharp & Dohme. Is the original research trade name Brevital? No, oh, is the original research trade name Vraylar? No, that's not right. Is the original research trade name of zuranolone Uzedy? No, oh, after verification, the original research preparation of zuranolone has not been approved for marketing in any country around the world so far, the core compound patent will expire in China in 2039, there is no public information on marketed dosage forms and specifications, and it has not been included in the domestic or FDA reference preparation catalog. Up to now, there is no publicized API registration number of zuranolone on the domestic CDE API registration platform, and no corresponding preparation has been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for zuranolone, most of which are available in stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the quality control requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various compliance needs of pharmaceutical companies in the R&D and quality research stages.