← Back to The Docket JUN 1 2026
APPROVED · 120 DAYS AGO
— Cypsedo (cipepofol)
for Induction and maintenance of general anesthesia; procedural sedation
NDA
FDA approved Cypsedo (cipepofol) injection for induction and maintenance of general anesthesia. Cipepofol is a short-acting GABA-A positive allosteric modulator ~4-6× more potent than propofol, and Cypsedo is the first China-originated innovative intravenous anesthetic to receive FDA marketing authorization.
About
Procedural sedation uses sedating and pain-relieving medicines to make non-surgical procedures tolerable while keeping the person breathing on their own, and it is common in emergency rooms and operating rooms. Cypsedo (cipepofol) is an intravenous anesthetic that binds to GABA-A receptors in the brain, boosting the calming signal those receptors carry and switching consciousness off quickly. Because that same signal quiets brain activity, the drug may bring on and hold general anesthesia or sedation during procedures, potentially with a fast onset and recovery.
Pivotal trial
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery
Source: ClinicalTrials.gov