Haisco Pharmaceutical Group said the FDA has approved Cipepofol (CYPSEDO) Injection, a Class 1 innovative intravenous anesthetic, for marketing in the United States. Cipepofol, independently developed by Haisco, is described as the first China-originated innovative intravenous anesthetic to receive FDA approval and enter the global market.
Intravenous anesthetics are widely used in surgery and intensive care, but clinicians have long faced challenges such as injection pain and respiratory depression. Cipepofol (Chinese trade name: Sishuning) is China’s first independently developed Class 1 IV anesthetic with global independent intellectual property rights. In China, it is approved for sedation and anesthesia in non–tracheal intubation surgeries and procedures, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in the intensive care unit. In September 2025, its indication was expanded to include induction and maintenance of general anesthesia in children and adolescents.
Development of Cipepofol began in 2012. Haisco’s R&D team modified the molecular structure by introducing a chiral cyclopropyl group and conducted extensive screening and safety evaluations, ultimately identifying a new drug candidate with favorable efficacy and safety profiles. Clinical studies conducted in China and internationally showed that Cipepofol retained rapid onset and complete recovery characteristics while reducing intraoperative respiratory depression, cardiovascular adverse reactions, and injection pain compared with standard options.
According to Haisco, the clinical data indicate lower risk of respiratory depression, more stable hemodynamics, and milder injection pain with Cipepofol, including in elderly and pediatric patients. The company said these attributes improve patient comfort and safety during anesthesia and may support more accurate and successful diagnosis and treatment.
Cipepofol was first approved in China by the National Medical Products Administration in December 2020. Subsequent approvals have broadened its use to additional indications, including induction of general anesthesia, fiberoptic bronchoscopy, and sedation in intensive care. In September 2025, dosing and administration for pediatric and adolescent general anesthesia were added.
As of May 2026, Cipepofol has been incorporated into more than 20 clinical guidelines and consensus documents, included in higher-education textbooks under China’s 14th Five-Year Plan, and listed in the National Reimbursement Drug List. The product has been adopted by over 3,300 medical institutions in China, with cumulative use in more than 40 million patient visits.
Cipepofol’s international development began after FDA cleared it for clinical trials in 2021. It received a waiver for Phase II trials in the U.S. and proceeded directly to pivotal Phase III studies, which were completed in 2024 and included head-to-head comparisons against standard-of-care anesthetics. The New Drug Application was accepted by FDA in July 2025.
Following U.S. approval, Haisco said it is working to advance commercialization of Cipepofol in the U.S. and other regions through partnerships. The company is also considering a marketing authorization application in Europe at an appropriate time, with the goal of expanding access to the anesthetic in additional markets.
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