Drugs / Cipepofol
Cipepofol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CIPEPOFOL | — | 2026-05-29 | fda.gov ↗ |
Trials 79 · started per year
today
US approved 2026
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06293144 | Nov 2023 → May 2024 | osteoarthritis, knee | Second Hospital of Shanxi Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT06293131 | May → Sep 2023 | osteoarthritis, knee | Second Hospital of Shanxi Medical University | Completed | No outcome recorded |
| Phase 0 | NCT05266560 | Mar 2022 → Jul 2024 | depressive disorder | First Affiliated Hospital of Chongqing Medical University | Unknown | No outcome recorded |
| Phase 115 trials · 1 met primary | ||||||
| Phase 1 | NCT06795204 | Apr → May 2024 | cardiac rhythm disease | Haisco-USA Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 1 | NCT07404306 | Aug 2022 → Oct 2023 | — | Haisco-USA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05614544 | Aug 2022 → Oct 2023 | — | Haisco-USA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05181007 | Dec 2021 → Mar 2022 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04294056 | May → Jun 2020 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03751969 | Mar → Nov 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT04145583 | Dec 2019 → Jan 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03745625 | Jan → Jul 2019 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03751956 | Jan → Feb 2019 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03758469 | Dec 2018 → Jan 2019 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04054063 | Nov → Dec 2016 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03773835 | May → Aug 2016 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04029766 | Nov → Dec 2015 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04037657 | Apr → Jun 2015 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04033939 | Apr → Nov 2014 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04669821 | Mar → Aug 2021 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04048811 | Dec 2019 → May 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04147416 | Nov 2019 → May 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03709056 | Dec 2017 → Feb 2018 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03698617 | Dec 2016 → Jun 2018 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03773042 | Dec 2016 → Jun 2017 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 311 trials · 5 met primary | ||||||
| Phase 3 | NCT07510945 | May 2026 → May 2028 expected | — | Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06391931 | Apr → Nov 2024 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05486416 | Jan → Jul 2024 | — | Haisco-USA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05478174 | Jul 2022 → Nov 2023 | — | Haisco-USA Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT04958746 | Jul → Sep 2021 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04711837 | Feb 2021 → Apr 2022 | — | Haisco-USA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04620031 | Dec 2020 → Jun 2021 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04511728 | Nov → Dec 2020 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04111159 | Dec 2019 → Jun 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | Met primary |
| Phase 3 | NCT03808844 | Mar → Aug 2019 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03674008 | Oct 2018 → Jan 2019 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 422 trials · 2 met primary | ||||||
| Phase 4 | NCT07696208 | Jul 2026 → Jan 2028 expected | ischemic stroke | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07670923 | Jul 2026 → Feb 2027 expected | — | General Hospital of Ningxia Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07697404 | Jun 2026 → Jul 2028 expected | — | Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 4 | NCT07673978 | Jun → Dec 2026 expected | subjective cognitive decline | The Second Affiliated Hospital of Chongqing Medical University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07118579 | Sep 2025 → Aug 2026 overdue | — | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07028593 | Jul 2025 → Oct 2027 expected | myocardial infarction | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06934811 | May 2025 → Dec 2026 expected | acute respiratory distress syndrome, cardiogenic shock | First Affiliated Hospital of Wannan Medical College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06952608 | Apr 2025 → Feb 2026 overdue | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 4 | NCT06773351 | Feb → Dec 2025 overdue | — | Feng Gao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06740201 | Jan → Mar 2025 overdue | — | Haisco Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 4 | NCT06674226 | Dec 2024 → Apr 2026 | delirium | Wang Tianlong | Completed | No outcome recorded |
| Phase 4 | NCT06344949 | Nov 2024 → Oct 2025 | — | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06538883 | Aug 2024 → Apr 2026 | — | Zhongda Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06253078 | Apr 2024 → Feb 2025 | — | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06425757 | Apr 2024 → Apr 2025 | plasma protein metabolism disease | Xie Kangjie | Completed | No outcome recorded |
| Phase 4 | NCT05881291 | Jun 2023 → Jul 2024 | hypotensive disorder | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | Met primary |
| Phase 4 | NCT05664386 | Apr 2023 → Oct 2024 | — | Xiumei Song | Unknown | No outcome recorded |
| Phase 4 | NCT05706337 | Feb → Sep 2023 | — | Xiumei Song | Unknown | No outcome recorded |
| Phase 4 | NCT05522998 | Jan → Jun 2023 | — | The Third People's Hospital of Chengdu | Completed | Met primary |
| Phase 4 | NCT05518929 | Sep 2022 → Aug 2023 | gastric cancer, gastric ulcer, gastrointestinal polyp | RenJi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06095570 | Jul 2022 → Dec 2023 | — | The Second Affiliated Hospital of Hainan Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05035069 | Sep 2021 → Feb 2022 | — | Haisco Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase not applicable22 trials · 2 met primary | ||||||
| — | NCT07799623 | Sep 2026 → Jan 2027 expected | brain neoplasm, delirium | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| — | NCT07805876 | Sep 2026 → Sep 2028 expected | brain neoplasm | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07601256 | Aug 2026 → Dec 2030 expected | infectious disease with sepsis, lung disorder | Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| — | NCT07663695 | Jun → Dec 2026 expected | hypotensive disorder | General Hospital of Ningxia Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07462949 | Mar → Apr 2026 | — | Guangzhou General Hospital of Guangzhou Military Command | Completed | No outcome recorded |
| — | NCT07328958 | Jan → Dec 2026 expected | — | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| — | NCT07081477 | Aug 2025 → Jun 2027 expected | — | The First People's Hospital of Lianyungang | Not yet recruiting | No outcome recorded |
| — | NCT06976996 | Mar → Dec 2025 overdue | — | Northern Jiangsu People's Hospital | Active not recruiting | No outcome recorded |
| — | NCT06735430 | Mar → Aug 2025 | appendicitis | Tongji Hospital | Completed | No outcome recorded |
| — | NCT06531915 | Dec 2024 | — | Anhui Provincial Hospital | Unknown | No outcome recorded |
| — | NCT06413862 | Aug → Sep 2024 overdue | — | Baoding First Central Hospital | Not yet recruiting | Met primary |
| — | NCT06015074 | Jun → Dec 2024 | biliary tract disorder | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT06312345 | Mar → May 2024 | — | Le Yu | Unknown | No outcome recorded |
| — | NCT06258967 | Feb → Dec 2024 | — | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT06172140 | Jan → Apr 2024 | — | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Completed | Met primary |
| — | NCT06178926 | Aug 2023 → Dec 2024 | liver cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| — | NCT05843383 | May 2023 → Dec 2024 | — | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT06287138 | May 2023 → Dec 2024 | — | Capital Medical University | Unknown | Mixed |
| — | NCT05517408 | Sep → Nov 2022 | gastric cancer, gastric ulcer, intestinal cancer, intestinal polyp | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT05892471 | Aug 2022 → Aug 2023 | — | Le Yu | Unknown | No outcome recorded |
| — | NCT05294679 | Jun → Dec 2022 | — | Sichuan Provincial People's Hospital | Completed | No outcome recorded |
| — | NCT04958382 | Dec 2021 → Dec 2023 | insomnia | Sichuan Provincial People's Hospital | Unknown | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 0 | NCT06205719 Comparator | Jun 2024 → May 2025 | — | Sichuan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04142970 Comparator | Jan → Aug 2020 | chronic kidney disease | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04197661 Comparator | Dec 2019 → Jan 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04145596 Comparator | Nov 2019 → Apr 2020 | — | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| — | NCT07584902 Comparator | Apr → Oct 2026 expected | hepatobiliary disorder | Gang Chen | Not yet recruiting | No outcome recorded |
| — | NCT07376577 Background | Jan 2026 → Mar 2028 expected | — | The First Affiliated Hospital of Xinxiang Medical College | Recruiting | No outcome recorded |
| — | NCT07268872 Comparator | Nov 2025 → Aug 2026 overdue | immune system disorder | Henan Provincial People's Hospital | Enrolling by invitation | No outcome recorded |
| — | NCT06617039 Comparator | Oct 2024 → Jul 2025 overdue | — | Northern Jiangsu People's Hospital | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-06-26 | Haisco Pharmaceutical Group Co., Ltd. | Regulatory 新华网：海思科迈向创新第一梯队 haisco.com ↗
2026年5月30日，海思科医药集团自主研发的1类静脉麻醉创新药环泊酚注射液（英文商品名：CYPSEDO），正式获得美国食品药品监督管理局（FDA）上市批准。 |
| 2026-06-02 | Haisco Pharmaceutical Group Co., Ltd. | Regulatory 2026.6.1 中国1类静脉麻醉创新药环泊酚获美国FDA批准上市 haisco.com ↗
环泊酚注射液（英文通用名：Cipepofol Injection，中文商品名：思舒宁®，英文商品名：CYPSEDO）在美国的新药上市申请获得批准，用于成人全身麻醉诱导。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-26 | Haisco Pharmaceutical Group Co., Ltd. | 新华网：海思科迈向创新第一梯队 haisco.com ↗ |
| 2026-06-02 | Haisco Pharmaceutical Group Co., Ltd. | 2026.6.1 中国1类静脉麻醉创新药环泊酚获美国FDA批准上市 haisco.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 93 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cipepofol | “HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery” NCT07510945 ↗3“Ciprofol (also known as cipepofol and HSK3486), is a compound similar to propofol in chemical structure and hypnotic effect.” PMID 38716419 ↗ Apr 2024 |
| Known as | Ciprofol | “Effects of Voriconazole on the Safety, Pharmacokinetics and Pharmacodynamics of Ciprofol (HSK3486), a Novel Intravenous Anaesthetic, in Healthy Participants: A Prospective,...” PMID 41836529 ↗ Jan 202657“Ciprofol (HSK3486; Haisco Pharmaceutical Group Co., Ltd., Chengdu, China), developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy...” PMID 34924506 ↗ May 2022 “EC50 of Ciprofol Combined With Remifentanil for Inhibiting Tracheal Responses in Patients Undergoing Gynecological Surgery: a Two-phase Up-and-down Sequential Allocation Study” NCT07462949 ↗ “Ciprofol, as a new intravenous general anesthetic, can significantly reduce the occurrence of hypotension and decrease burst suppression compared with propofol.” NCT07805876 ↗ “HSK3486 (ciprofol) is a 2,6-disubstituted phenol derivative that acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABA A ) receptor.” PMID 36647565 ↗ Jan 2023 “The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.” NCT07601256 ↗ “Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation” PMID 39455495 ↗ Oct 2024 “Anesthesia induction and maintenance will be performed with ciprofol and remifentanil.” NCT07328958 ↗ “intravenous injection of ciprofol (0.4mg/kg)” NCT06172140 ↗ “Ciprofol on Day 1 and Day 5” NCT05181007 ↗ |
| Known as | Haisco HSK3486 | “Clinical studies of candidate compound 6 (Haisco HSK3486) as a general anesthetic are being performed in Australia and China.” PMID 28430430 ↗ Apr 2017 |
| Known as | HSK-3486, (R)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL4094894 ↗ |
| Known as | HSK3486 | “Ciprofol (HSK3486) is a novel intravenous anesthetic agent that has demonstrated efficacy non-inferior to propofol for induction and maintenance of general anesthesia, with an...” NCT06952608 ↗33“Ciprofol (HSK3486; Haisco Pharmaceutical Group Co., Ltd., Chengdu, China), developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy...” PMID 34924506 ↗ May 2022 “Ciprofol (also known as cipepofol and HSK3486), is a compound similar to propofol in chemical structure and hypnotic effect.” PMID 38716419 ↗ Apr 2024 “In contrast, Ciprofol (HSK3486), a novel anesthetic, reduces hypotension during induction.” NCT06258967 ↗ “the Phase II research project of ciprofol (HSK3486), the patent” PMID 40829819 ↗ Aug 2025 |
| Action | Activate | “acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABA A ) receptor” PMID 36647565 ↗ Jan 2023 |
| Modality | Small molecule | “developed as a novel 2,6-disubstituted phenol derivative” PMID 34924506 ↗ May 2022 |
| Route | Intravenous | “HSK3486 intravenous (iv)” NCT03674008 ↗ |