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ciprofol (HSK 3486 / ciprofol / Cyclopofol)

✓ Approved

Haisco Pharmaceutical Group · Small Molecule · Small Molecule

What is ciprofol?

ciprofol is a small molecule developed by Haisco Pharmaceutical Group. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesHSK 3486, ciprofol, Cyclopofol
CompanyHaisco Pharmaceutical Group
Drug ClassSmall Molecule
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Haisco Pharmaceutical Group

Therapeutic Indications

ciprofol is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Nervous system disordersAnaesthesia✓ Approved
Nervous system disordersSensory loss✓ Approved

Related Research Articles

PubMedDrug design, development and therapy2026-10-18

Weight-Scaled Dose Optimization of Intravenous Anesthetics in Patients with Obesity: General Anesthesia and Procedural Sedation.

Gu Han H, Qian Haoran H, Chen Kefan K, Zhu Juan J et al.

Obesity alters the pharmacokinetics and pharmacodynamics of intravenous anesthetics, complicating weight-based dose selection. This narrative review examines weight-scaling strategies and effective-dose estimates (ED50/ED95) for propofol, ciprofol, and remimazolam in patients with obesity undergoing general anesthesia or procedural sedation. Targeted searches of PubMed/MEDLINE were supplemented by DOI and title searches in Europe PMC and publisher records. Evidence was selected purposively according to clinical relevance, study design, population, dosing phase, and outcome, prioritizing obesity-specific studies. General pharmacological evidence was considered separately to contextualize findings and evidence gaps. The evidence supporting dose optimization is broader for propofol than for ciprofol or remimazolam. Propofol studies support weight-informed initial dosing followed by individualized adjustment, although no single weight scalar is appropriate across all settings. Obesity-specific induction and dose-finding studies of ciprofol and remimazolam provide preliminary information, but limited study numbers and population diversity restrict generalizability. Their maintenance dosing in patients with obesity remains insufficiently characterized. ED50/ED95 values reflect responses under specific study conditions and should not be interpreted as routine clinical dosing recommendations. For procedural sedation, dose selection requires consideration of the intended sedation depth, concomitant medications, and respiratory risk. Weight-based calculations provide initial dose estimates, while titration guided by clinical response and appropriate pharmacodynamic monitoring remains essential. The proposed dosing framework distinguishes approaches supported by broader clinical evidence from preliminary findings and suggestions based on pharmacological reasoning. The latter require further validation before routine adoption. Adequately powered, multicenter comparative trials should address maintenance dosing, extreme obesity, and clinically meaningful safety and recovery outcomes.

PMID 42893269
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PubMedFrontiers in medicine2026-10-17

Ciprofol versus propofol for general anesthesia during thoracoscopic surgery: a randomized double-blind trial.

Wang Yu Y, Geng Yizhi Y, Yan Yaodong Y, Gao Xinying X et al.

Ciprofol is a novel intravenous anesthetic with potentially improved hemodynamic stability and fewer injection-related adverse effects than propofol. This study compared ciprofol and propofol for general anesthesia in patients undergoing video-assisted thoracoscopic surgery (VATS). In this prospective, randomized, double-blind trial, 120 adults undergoing elective thoracoscopic surgery were randomized to ciprofol (n = 60) or propofol (n = 60). MAP, HR, and BIS were assessed at eight predefined perioperative time points using linear mixed-effects models. The repeated binary outcome of BIS ≥60 was analyzed using a generalized linear mixed-effects model. Induction characteristics, injection pain, recovery profiles, and perioperative adverse events were also evaluated. MAP differed significantly between groups, with higher values in the ciprofol group at loss of consciousness and after tracheal intubation. HR was modestly higher at selected early time points, without a significant group-by-time interaction. BIS was higher with ciprofol during the early intraoperative period, and BIS ≥60 was more frequent at loss of consciousness (76.7% vs. 43.3%, p < 0.001), but not thereafter. Ciprofol was associated with shorter induction time (38.3 vs. 46.0 s, p < 0.001), less injection pain (5.0% vs. 20.0%, p = 0.025), and shorter PACU stay (48.0 vs. 55.7 min, p = 0.011). No significant differences were observed in supplemental anesthetic requirements, emergence time, or perioperative adverse events. Ciprofol showed a perioperative profile broadly comparable to propofol, with transient differences in hemodynamic parameters and higher BIS during the early intraoperative period. Ciprofol was associated with faster induction, less injection pain, and shorter PACU stay. Larger multicenter studies are warranted to confirm these findings. https://www.chictr.org.cn/showproj.html?proj=203394, Identifier: ChiCTR2400082924.

PMID 42889180
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PubMedFrontiers in pharmacology2026-10-11

Ciprofol versus propofol for painless gastrointestinal endoscopy: a dose-stratified systematic review and meta-analysis.

Liu Jing J, Yu Jun J, Chen Zhiyong Z, Bai Yuchao Y et al.

We compared ciprofol with propofol for painless gastrointestinal endoscopy, focusing on dose, recovery, induction, satisfaction, and adverse events. PubMed and Embase were searched through May 2026 for randomized controlled trials in adults undergoing painless gastrointestinal endoscopy. We pooled weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes using random-effects models. Risk of bias was assessed with the Cochrane tool. The protocol was prospectively registered in PROSPERO (CRD420251088249). Eleven trials (2,084 participants) met the criteria. Recovery was statistically longer with ciprofol (WMD 0.83 min, 95% CI 0.16 to 1.49; P = 0.01), but the absolute difference was under 1 min; the difference was observed at 0.4 and 0.5 mg/kg. Induction time and physician and patient satisfaction did not differ significantly. Ciprofol was associated with fewer reported episodes of hypotension (RR 0.81, 95% CI 0.72-0.90), injection pain (RR 0.13, 95% CI 0.08-0.22), respiratory depression (RR 0.47, 95% CI 0.27-0.83), and hypoxemia (RR 0.64, 95% CI 0.42-0.96). Ciprofol and propofol produced broadly comparable procedural outcomes. The apparent advantages for selected adverse events and the dose-related recovery pattern are uncertain because all trials were conducted in China, several pooled outcomes were highly heterogeneous, outcome definitions varied, and publication bias was possible. The dose-stratified findings are exploratory, and the results are hypothesis-generating and require confirmation in larger international trials. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251088249, identifier PROSPERO CRD420251088249.

PMID 42856863
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PubMedDrug design, development and therapy2026-10-04

Effects of Ciprofol- versus Remimazolam-Based Total Intravenous Anesthesia on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Controlled Trial.

Zeng Jinfang J, Ye Ying Y, Li Zijian Z, Yang Shu S et al.

Postoperative nausea and vomiting (PONV) remains common after laparoscopic cholecystectomy. Whether ciprofol-based anesthesia reduces PONV compared with remimazolam-based anesthesia remains unclear. In this single-center, randomized, assessor-blinded, parallel-group trial, adults undergoing laparoscopic cholecystectomy were assigned to receive ciprofol- or remimazolam-based total intravenous anesthesia. All participants received standardized antiemetic prophylaxis with dexamethasone and ondansetron, together with a standardized analgesic protocol. The primary outcome was the cumulative incidence of PONV within 24 h after surgery. Secondary outcomes included nausea, vomiting, rescue antiemetic use, postoperative pain, QoR-15 score, adverse events, and intraoperative hemodynamic variables. A total of 146 patients were randomized, with 73 patients in each group. The incidence of PONV within 24 h was lower in the ciprofol group than in the remimazolam group [23/73 (31.5%) vs 43/73 (58.9%); RR 0.53, 95% CI 0.36-0.79; P = 0.001]. This association remained significant after adjustment for clinically relevant PONV risk factors(adjusted OR 0.289, 95% CI 0.135-0.623; P = 0.002). Ciprofol was also associated with lower incidences of nausea, vomiting, and rescue antiemetic use. Postoperative pain, QoR-15 score, overall adverse events, and vasopressor use were similar between groups. Under a standardized prophylactic antiemetic protocol, ciprofol-based total intravenous anesthesia was associated with a lower 24-h incidence of PONV than remimazolam-based anesthesia in adults undergoing laparoscopic cholecystectomy. No statistically significant between-group differences were observed in postoperative recovery measures, adverse events, or vasopressor use; however, the trial was not powered to establish equivalence for these secondary or safety outcomes. Further multicenter studies are needed to confirm the robustness and generalizability of this finding across different multimodal antiemetic strategies.

PMID 42828344
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PubMedDrug design, development and therapy2026-09-25

Equipotent Doses and ED95 Extrapolation: Methodological Concerns in Trials of Ciprofol-Esketamine/Sufentanil for Elderly ESD [Response to Letter].

Qin Xiaoxue X, Jiang Hui H, Xie Yan Y, Liu Qian Q et al.

PMID 42787070
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PubMedDrug design, development and therapy2026-09-24

Re: "Ciprofol versus Propofol for Emergence Agitation and Recovery Quality in Pediatric Dental Anesthesia: A Randomized Controlled Trial" [Response to Letter].

Zhang Yaqiu Y, Wu Long L, Gao Zhenzhen Z, Zhang Minjuan M et al.

PMID 42780677
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