← Back to The Docket JUN 1 2026
APPROVED · 60 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
Cypsedo (cipepofol) is a short-acting sedative used to induce and maintain general anesthesia for surgeries and procedures. It works by calming brain activity through a specific receptor system, with a potency several times greater than a common anesthetic called propofol. This profile may offer clinicians a controlled option for maintaining the reduced consciousness needed for safe and effective procedures.
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