Drug Update · Anesthesiology

FDA Approves Cipepofol (CYPSEDO) for Induction of General Anesthesia

September 07, 2026

Drug

cipepofol (CYPSEDO) injectable emulsion

FDA approval date

05/29/2026

Indication

Induction of general anesthesia in adults undergoing surgery

Randomized trial primary result (MAP AUC)

Median AUC -8505.0 mm Hg·s (cipepofol) vs -13 189.0 mm Hg·s (propofol); P < .001 [1]

Postinduction hypotension incidence

70.5% (cipepofol) vs 88.5% (propofol); P = .01 [1]

Clinical Perspective

Anesthesiologists and perioperative clinicians caring for adults undergoing surgery are the immediate audience for this approval. The FDA approval and clinical-trial data support cipepofol as an intravenous induction agent for general anesthesia in adults, with randomized-trial evidence of smaller MAP AUC and a lower reported incidence of postinduction hypotension versus propofol in a high-cardiovascular-risk surgical cohort. Can cipepofol be used beyond induction for maintenance of general anesthesia, or is its role limited to induction per the label and trial data?

Dr. Neha Bansal, MBBS, MD (Anaesthesiology) · Anesthesiology

The FDA approved CYPSEDO (cipepofol injectable emulsion) for induction of general anesthesia in adults undergoing surgery, effective 05/29/2026, according to the agency approval letter to the sponsor ^[3]. Clinical trial data in adults include randomized and double-blind controlled studies; a randomized clinical trial reported that cipepofol produced a median area under the curve (AUC) of the mean arterial pressure (MAP) difference from baseline of -8505.0 mm Hg·s versus -13 189.0 mm Hg·s with propofol during the initial 15 minutes postinduction (P < .001) ^[1]^[2]^[3].

Clinical Context

CYPSEDO is an intravenous injectable emulsion formulation of cipepofol indicated for induction of general anesthesia in adults undergoing surgery ^[2]^[3]. The product is supplied as 50 mg/20 mL (2.5 mg/mL) single-dose vials and is to be prepared and administered by health care providers trained in induction of general anesthesia, per prescribing information ^[2]. Clinicians should consult current prescribing information for full dosing guidance. Approval and labeling were issued to Haisco-USA Pharmaceuticals, Inc. (NDA 220482); controlled-substance scheduling was noted as pending in the approval correspondence ^[3]. The FDA prescribing information summarizes clinical trial experience from three double-blind, controlled clinical trials supporting the safety database ^[2].

Key Findings

A randomized clinical trial in patients with severe aortic stenosis scheduled for TAVR found that cipepofol had a median AUC of the MAP difference from baseline during the initial 15 minutes postinduction of -8505.0 mm Hg·s compared with -13 189.0 mm Hg·s with propofol (P < .001) ^[1].
In that randomized trial, the incidence of postinduction hypotension was 70.5% in the cipepofol group versus 88.5% in the propofol group (P = .01) ^[1].
The randomized trial reported a smaller median dose of norepinephrine during the first 15 minutes postinduction with cipepofol (6.0 μg [0.0-10.0]) versus propofol (10.0 μg [5.0-20.0]; P = .006) ^[1].
The FDA prescribing information describes three double-blind, controlled clinical trials in adults undergoing general anesthesia (Trials 1, 2, and 3) that together included 1,080 patients aged 18 to 86, with 723 patients treated with CYPSEDO and 357 treated with propofol injectable emulsion; these trials support the safety database for induction of general anesthesia ^[2].
Injection site pain was reported at lower proportions in CYPSEDO-treated patients across Trials 1–3 (17%–19% in CYPSEDO-treated patients) compared with propofol-treated patients (77%, 45%, and 59% across Trials 1–3); risk differences and p-values are reported in the labeling ^[2].

Safety & Tolerability

The prescribing information lists the most common adverse reactions (incidence ≥2%) in adults undergoing induction of general anesthesia: hypotension, nausea, injection site pain, procedural pain, hypertension, procedural hypotension, asthenia, vomiting, dizziness, hypoxia, bradycardia, tachycardia, constipation, headache, and anemia ^[2].
Perioperative myoclonia (e.g., myoclonus, involuntary muscle contractions, muscle twitching) occurred in CYPSEDO-treated patients in trials ^[2].
Postmarketing adverse reactions identified include anaphylactic shock and phlebitis ^[2].

Study Design

The NDA for CYPSEDO (NDA 220482) was approved by FDA and reflected labeling and clinical-trial data submitted by Haisco-USA Pharmaceuticals, Inc. ^[3]. The prescribing information cites three double-blind, controlled clinical trials (Trials 1, 2, and 3) that included 1,080 adults (723 CYPSEDO; 357 propofol) supporting safety for induction of general anesthesia ^[2]. Separately, a single-center randomized clinical trial of patients with severe aortic stenosis scheduled for TAVR randomized 124 patients 1:1 to cipepofol versus propofol (122 patients analyzed) and used the AUC of the MAP difference from baseline during the initial 15 minutes postinduction as the primary outcome ^[1].

FAQ

Q1 What is CYPSEDO (cipepofol) approved for?

CYPSEDO (cipepofol injectable emulsion) is approved by the FDA for induction of general anesthesia in adults undergoing surgery. The approval and labeling were issued to Haisco-USA Pharmaceuticals, Inc. as NDA 220482; controlled-substance scheduling was noted as pending in the approval correspondence.

Q2 How does cipepofol work?

Information on the mechanism of action of cipepofol was not available in the provided source excerpts. The prescribing information lists Clinical Pharmacology and Mechanism of Action sections in its table of contents, but the specific mechanistic description was not present in the provided excerpts.

Q3 What is the recommended dose of CYPSEDO for induction of general anesthesia?

The prescribing information specifies weight-based recommended initial intravenous induction doses by age group, BMI group, and ASA-PS classification. Examples from Table 1 include: ASA-PS I or II adults under 65 years with BMI ≤40 kg/m², initial induction dose 0.4 mg/kg over 30 seconds with an additional 0.2 mg/kg if needed; adults 65 years and older with BMI ≤40 kg/m², 0.3 mg/kg over 30 to 60 seconds with an additional 0.15 mg/kg if needed; for adults of any age with BMI >40 kg/m², initial dose 0.2 mg/kg to 0.25 mg/kg over 30 seconds with repeat dosing at 50% of the initial dose if needed. The recommended dosage for ASA-PS IV or higher has not been established. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of cipepofol?

The prescribing information lists the most common adverse reactions (incidence ≥2%) observed in adult induction trials: hypotension, nausea, injection site pain, procedural pain, hypertension, procedural hypotension, asthenia, vomiting, dizziness, hypoxia, bradycardia, tachycardia, constipation, headache, and anemia. Perioperative myoclonia occurred in CYPSEDO-treated patients in trials, and postmarketing reports have included anaphylactic shock and phlebitis.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Cipepofol (CYPSEDO) for Induction of General Anesthesia

Direct Clinical Takeaway & Evidence Summary

FDA Approves Cipepofol (CYPSEDO) for Induction of General Anesthesia

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

Cite & Reference This Monograph

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