In a Phase III study, Cypsedo induced anesthesia at a comparable rate to propofol, while fewer patients reported injection-site pain.
General anesthesia is often described as “putting a patient to sleep,” but it is more complex than that. The drugs must make patients unconscious, prevent pain and memory formation and wear off predictably, all while clinicians keep breathing, blood pressure and other vital signs stable.
The FDA has approved a new intravenous (IV) medication called Cypsedo (cipepofol) to help adults fall asleep at the start of surgery. Developed by Haisco Pharmaceutical Group, Cypsedo is described as the first China-originated intravenous anesthetic to receive FDA approval.
In the US, Cypsedo is approved for the induction of general anesthesia in adults undergoing surgery. In China, cipepofol is also approved for other anesthesia and sedation settings.
IV anesthetics are widely used in modern surgery. However, they can come with challenges, including respiratory depression when breathing becomes too slow or shallow, and injection-site pain during anesthesia induction.
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Byfavo (remimazolam), another IV anesthetic, received FDA approval in 2020 for procedural sedation in adults undergoing short procedures
Cypsedo belongs to the same family as propofol, a widely used IV anesthetic in operating rooms and procedural settings. Both drugs work by boosting a “calming signal” in the brain, acting on gamma-aminobutyric acid type A (GABA-A) receptors. This helps patients enter the unconscious state needed for surgery.
In a multicenter Phase III study, Cypsedo was compared with propofol in 255 adults undergoing elective surgery. Researchers wanted to see whether cipepofol could induce anesthesia as reliably as propofol, the standard comparator.
It did. Successful anesthesia induction occurred in 97.0% of participants who received cipepofol and 97.6% of those who received propofol, meeting the study’s goal of showing comparable performance.
The bigger difference was injection-site pain, a common issue with propofol. In the study, 18.0% of participants who received cipepofol reported injection-site pain compared with 77.1% of those who received propofol.
The study also looked at whether patients maintained the desired depth of anesthesia without major cardiac or respiratory events. Results were similar between the two groups, with 48.2% of participants in the cipepofol arm and 50.6% in the propofol arm meeting that measure.
Cipepofol was first approved in China in 2020 and is now used there across several anesthesia and sedation settings, including surgery, procedures and intensive care.
While new to the US, cipepofol has been used extensively in China. Since its 2020 approval, it has been adopted by more than 3,300 medical institutions, according to Haisco.
The US approval is currently focused on induction, the initial process of putting a patient to sleep. Cypsedo gives doctors another IV anesthesia option, supported by the Phase III data.
Haisco will be advancing US commercialization plans and may later consider a marketing authorization application in Europe,
Haisco is also building its early-stage drug discovery presence through a new collaboration with Eli Lilly. The companies plan to work on up to five drug programs across multiple therapeutic areas, with Haisco handling discovery work and Lilly taking over later development and commercialization.
FAQs
Will Cypsedo replace propofol?
Not right away. Propofol is still widely used, and hospitals will decide where Cypsedo fits based on clinical use, supply, cost and formulary review.
How is general anesthesia different from sedation?
General anesthesia puts a patient into a deeper unconscious state for surgery. Sedation is usually lighter and is often used for shorter or less invasive procedures.
What is the difference between IV and inhaled anesthesia?
IV anesthetics are given through a vein and are often used to start anesthesia. Inhaled anesthetics are delivered through the lungs and may be used to keep a patient under during surgery.
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