Haisco：CYPSEDO® Ciprofol received a US FDA marketing application.
Ciprofol Injection is a Category 1 intravenous anesthetic drug developed by Haisco with full independent intellectual property rights.
In China, the drug was first approved for marketing in December 2020 and has since been approved for multiple indications, including sedation for gastroscopy and colonoscopy, induction and maintenance of general anesthesia, sedation for bronchoscopy, sedation and anesthesia during non-intubated surgical/procedural interventions, sedation during intensive care, and sedation and anesthesia for gynecological outpatient procedures. In the United States, Ciprofol Injection received FDA clearance for clinical trials in January 2021, exempted from Phase II and directly entering pivotal Phase III clinical trials. According to the Insight database, Haisco is conducting three Phase III clinical trials of Ciprofol Injection in the United States for the indication of general anesthesia induction. Clinical study results from both China and abroad have demonstrated that ciprofol retains the advantages of rapid onset and thorough recovery while significantly reducing the incidence of intraoperative respiratory depression and cardiovascular adverse reactions, as well as reducing injection pain. With its lower risk of respiratory depression, more stable hemodynamic profile, reduced injection pain, and individualized care for elderly and pediatric patients, ciprofol not only makes “comfortable treatment” more compassionate—directly addressing patients’ expectations of being “pain-free” and reducing fear of surgery during anesthesia induction—but also significantly improves the comfort and safety of the diagnostic and treatment process from both physiological and psychological perspectives, while greatly enhancing the accuracy and success rate of physician-performed procedures.
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