Cipepofol, a new propofol-like anaesthetic, is Schedule IV — while propofol itself still is not

Cipepofol, a new intravenous anaesthetic, is now a Schedule IV controlled substance in the United States, placed there by a Drug Enforcement Administration interim final rule that took effect on the day it published, August 27, 2026.

The rule is the instrument that changes the law, not a proposal [1]. It became effective immediately on publication [1], so cipepofol has been a Schedule IV substance since that date [1]. This is done under the Improving Regulatory Transparency for New Medical Therapies Act, which requires an immediate interim final rule without prior notice and comment for certain newly approved drugs [1]. The Food and Drug Administration had approved cipepofol, for inducing general anaesthesia in adults undergoing surgery, on May 29, 2026 [1], after DEA received the Department of Health and Human Services' evaluation and Schedule IV recommendation on May 6, 2026 [1]. Comments on the rule and requests for a hearing are due by September 28, 2026 [1]; DEA must still issue a final rule after that process under the Controlled Substances Act's scheduling criteria [1].

What has not changed: propofol itself. The rule places only cipepofol in Schedule IV [1]; propofol remains uncontrolled under federal law [1]. The rule notes that cipepofol shares a mechanism of action with propofol, which it describes as having "proposed" Schedule IV status due to abuse and dependence liability, and with propofol's prodrug fospropofol, which is Schedule IV [1]. That propofol recommendation dates to 2010, and the rule does not state that propofol has been scheduled [1].

Cipepofol also is not something that has shown up as a street or diversion problem. DEA's own lab-encounter database records zero law-enforcement encounters of it in the US [1], and an estimated 14.5 million patients have been treated with it in China since 2021 with no postmarket reports of abuse or misuse [1]. The scheduling instead rests on a human abuse-potential study, where subtherapeutic doses scored significantly higher than placebo on Drug Liking, comparable to propofol but not exceeding it [1], plus rat self-administration data in propofol-trained animals showing the drug maintained lever-pressing [1]. The population the rule identifies as at risk is healthcare workers with occupational access, the same group that has historically misused propofol [1].

Cipepofol is given intravenously as a 2.5 mg/mL emulsion [1]; overdose may lead to potentially fatal cardiovascular and respiratory depression if not promptly and adequately managed [1].

References

1. Schedules of Controlled Substances: Placement of Cipepofol in Schedule IV — Federal Register