27 completed, 2 recruiting, 2 unknown, 1 not yet recruiting. 15 Phase 1, 9 Phase 3, 5 Phase 2, 2 Not applicable, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 14, Withdrawn 1 |
| Phase 3 | 9 | Completed 8, Not yet recruiting 1 |
| Phase 2 | 5 | Completed 5 |
| Not applicable | 2 | Unknown 2 |
| Phase 4 | 2 | Recruiting 2 |
Follow HSK3486: new trials by email Literature Review of HSK3486 trials Research Report on HSK3486
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery HSK3486, propofol - General Anesthetic | Phase 3 | Not yet recruiting | Haisco Pharmaceutical Group Co., Ltd. | 400 | 2026-05-01 | 2026-04-06 |
| Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery in Video-Assisted Thoracoscopic Surgery Propofol, ciprofol - Myocardial Injury, Thoracic Diseases | Phase 4 | Recruiting | Tongji Hospital | 1058 | 2025-07-31 | 2026-01-28 |
| A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery Cipepofol - Anesthesia | Phase 4 | Recruiting | Haisco Pharmaceutical Group Co., Ltd. | 40 | 2025-01-06 | 2025-01-27 |
| Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) HSK3486, Moxifloxacin Hydrochloride, Placebo - Anesthesia; Adverse Effect, Cardiac Arrhythmia | Phase 1 | Completed | Haisco-USA Pharmaceuticals, Inc. | 48 | 2024-04-09 | 2026-01-13 |
| Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery HSK3486, Propofol - General Anesthesia | Phase 3 | Completed | Haisco-USA Pharmaceuticals, Inc. | 465 | 2024-01-12 | 2025-10-10 |
| Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation Propofol, Ciprofol - Liver Cancer, Ciprofol | Not applicable | Unknown | Zhejiang Cancer Hospital | 80 | 2023-08-01 | 2023-12-21 |
| Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery Ciprofol, Propofol - Anesthetics, Intravenous, Postoperative Complications | Not applicable | Unknown | Xijing Hospital | 280 | 2023-05-16 | 2024-04-09 |
| Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users HSK3486, Propofol, Placebo - General Anesthesia | Phase 1 | Completed | Haisco-USA Pharmaceuticals, Inc. | 42 | 2022-08-16 | 2023-10-13 |
| Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users HSK3486, propofol, Placebo - General Anesthesia | Phase 1 | Completed | Haisco-USA Pharmaceuticals, Inc. | 43 | 2022-08-16 | 2026-02-23 |
| Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia HSK3486, Propofol - General Anesthesia | Phase 3 | Completed | Haisco-USA Pharmaceuticals, Inc. | 400 | 2022-07-26 | 2025-10-10 |
| A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation HSK3486, Propofol - Sedation in Intensive Care | Phase 2 | Completed | Haisco Pharmaceutical Group Co., Ltd. | 20 | 2021-03-09 | 2022-05-27 |
| Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery HSK3486, Propofol - Anesthesia | Phase 3 | Completed | Haisco-USA Pharmaceuticals, Inc. | 255 | 2021-02-11 | 2025-10-10 |
| A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation HSK3486, Propofol - Sedation in Intensive Care | Phase 3 | Completed | Haisco Pharmaceutical Group Co., Ltd. | 135 | 2020-12-08 | 2022-05-27 |
| A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia HSK3486, Propofol - Induction and Maintenance of General Anesthesia | Phase 3 | Completed | Haisco Pharmaceutical Group Co., Ltd. | 129 | 2020-11-24 | 2022-05-31 |
| A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults HSK3486 - Anesthesia, Sedation | Phase 1 | Withdrawn | Sichuan Haisco Pharmaceutical Group Co., Ltd | 2020-03-30 | 2022-06-02 | |
| Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions HSK3486 - Chronic Renal Impairment | Phase 1 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 24 | 2020-01-05 | 2020-12-19 |
| Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects HSK3486 - Healthy Elderly Subjects | Phase 1 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 32 | 2019-12-25 | 2020-12-17 |
| A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets HSK3486, voriconazole +HSK3486 - Anesthesia, Sedation | Phase 1 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 16 | 2019-12-14 | 2020-12-19 |
| A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients HSK3486, Propofol, Propofol HSK3486 - Induction and Maintenance of General Anesthesia | Phase 2 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 46 | 2019-12-09 | 2020-12-17 |
| A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy HSK3486, Propofol - Sedation or Anesthesia | Phase 3 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 267 | 2019-12-06 | 2020-12-17 |
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Arrhythmias, Cardiac (1) · Liver Neoplasms (1) · Lung Neoplasms (1) · Postoperative Complications (1) · Renal Insufficiency, Chronic (1) · Thoracic Diseases (1)
Sichuan Haisco Pharmaceutical Group Co., Ltd (19) · Haisco-USA Pharmaceuticals, Inc. (6) · Haisco Pharmaceutical Group Co., Ltd. (5) · Tongji Hospital (1) · Xijing Hospital (1) · Zhejiang Cancer Hospital (1)
China (22) · United States (5) · Poland (1) · Spain (1)
Gao Jingui, Doctor (1) · Haopeng Zhang (1) · Jiangling Wang, Dr. (1) · Liyan Miao, PhD (1) · William Daley, MD (1) · Yan-hua Ding, PhD (1) · Yanhua Ding, PhD (1)
PMID 28430430, PMID 29203498, PMID 32415708, PMID 34417990, PMID 34601955, PMID 35157236, PMID 36217101, PMID 36647565, PMID 36680620, PMID 37272947, PMID 38074142, PMID 39455495, PMID 41836529, PMID 41858914