Effects of Alternating Ciprofol and Remimazolam on Intraoperative Motor and Somatosensory Evoked Potentials During Spine Surgery: A Randomized Crossover Trial

Intraoperative neurophysiological monitoring, including motor evoked potentials and somatosensory evoked potentials, is commonly used during spine surgery to help detect impending neurological injury. The quality of these signals can be affected by anesthetic agents. Ciprofol and remimazolam are newer intravenous hypnotic agents that may be suitable for total intravenous anesthesia during procedures requiring neurophysiological monitoring, but direct within-patient comparisons between the two agents are lacking. This single-center, prospective, randomized, two-sequence crossover trial will compare the effects of ciprofol and remimazolam, administered with remifentanil, on intraoperative MEP and SEP signal quality during spine surgery. Eligible participants will be randomized to receive either ciprofol followed by remimazolam or remimazolam followed by ciprofol during predefined stable intraoperative monitoring windows. The primary outcome is the within-participant difference in lower-extremity MEP peak-to-peak amplitude between the ciprofol and remimazolam periods. Secondary outcomes include SEP amplitude and latency, MEP latency, warning-threshold events, hemodynamic variables, rescue medication requirements, recovery characteristics, and postoperative neurological status.

Start Date01 Aug 2026

Sponsor / Collaborator-

ChiCTR2600127852

/ Not yet recruitingPhase 4IIT

Efficacy and safety of Esketamine for painless gastrointestinal endoscopy in elderly patients under continuous noninvasive hemodynamic monitoring: a randomized controlled trial

Start Date17 Jul 2026

Sponsor / Collaborator-

NCT07696208

/ Not yet recruitingPhase 4IIT

Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic Stroke: A Multicenter Randomized Open-label Parallel-group Trial (CONSTANCY)

Endovascular therapy (EVT) improves the prognosis of patients with acute ischemic stroke (AIS). EVT has been established as a standard of care for AIS caused with large vessel occlusion based on numerous randomized controlled trials. However, despite extensive attention to post-EVT blood pressure management as a potentially modifiable factor, the ability to achieve high reperfusion rates does not consistently translate into functional independence for a substantial number of patients. Thus, the focus has turned to the intra-procedural period, where blood pressure management may play a critical but underexamined role in determining functional outcomes independent of post-EVT care.
Guideline recommendation to maintain the blood pressure lowered to 185/110 mmHg before the EVT procedure in patients who have not received intravenous thrombolysis therapy. However, studies of blood pressure before reperfusion in this patient group have produced conflicting results. Thus, although randomized trials evaluating pre-thrombectomy blood pressure targets are yet unavailable, accumulating evidence suggests that active blood pressure lowering before reperfusion may be harmful, which underscores the importance of maintaining hemodynamic stability during the EVT procedure.
In this context, anesthetic management is a key determinant of intraprocedural blood pressure control. Propofol is the most commonly used general anesthetic during EVT surgery. However, propofol is a powerful venodilator and often provokes hypotension which may be especially detrimental in AIS patients. Ciprofol, a novel anesthetic/sedative, has been proven to possess excellent efficacy and safety which provides definitive general anesthesia/sedation while minimizing respiratory and hemodynamic depression. Before and during EVT, patients with hemodynamic stability may have better outcomes. Using ciprofol as the anesthesia agent may reduce the incidence and severity of hemodynamic instability during EVT. Therefore, it is of significant research value to investigate whether the use of ciprofol for general anesthesia is beneficial in AIS patients undergoing EVT.

Start Date01 Jul 2026

Sponsor / Collaborator

Haisco Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Ciprofol

100 Translational Medicine associated with Ciprofol

100 Patents (Medical) associated with Ciprofol

273

Literatures (Medical) associated with Ciprofol

31 Dec 2026·ANNALS OF MEDICINE

Effects of nine sedative-analgesic combinations on fatigue after gastrointestinal endoscopy: a randomized controlled 3 × 3 factorial trial protocol

Article

Author: Huang, Lei ; Kuai, Ling-yu ; Liu, Lin-lin ; Gui, Wen-hu ; Lv, Jun ; Peng, Ke ; Ji, Fu-hai ; Xu, Li-na

INTRODUCTION:

Post-procedural fatigue is common after sedated gastrointestinal endoscopy and prolongs recovery. We describe a protocol for a prospective, single-center, randomized, controlled, 3 × 3 factorial trial to evaluate the effects of different sedative-analgesic combinations on patient-reported fatigue after gastrointestinal endoscopy.

PATIENTS AND METHODS:

Three hundred and fifteen patients (aged ≥ 45 years, ASA physical status I or II) presenting for gastrointestinal endoscopy with planned intravenous sedation will be randomly allocated (1:1:1:1:1:1:1:1:1; block sizes 9 and 18) to one of nine equip-sized groups generated by the factorial combination of three sedatives (propofol, ciprofol, remimazolam) with three adjuvant analgesics (sufentanil, esketamine, lidocaine). Sedation will be titrated to Modified Observer's Assessment of Alertness/Sedation scores of 1-2. The primary outcome is the Christensen Fatigue Scale score (range 1-10; higher = worse) 30 min after the procedure. The secondary outcome is the composite incidence of intra-procedural hypotension (mean arterial pressure < 65 mmHg) and hypoxemia (SpO₂ < 90% for ≥ 10 s). Primary analysis will employ two-way factorial ANOVA to test the main effects of sedatives and analgesics on the 30-min fatigue score, with an exploratory interaction analysis.

DISCUSSION:

The results of this trial will provide high-resolution evidence on which sedative or analgesic agent most effectively mitigates early post-endoscopy fatigue, thereby informing patient-centered sedation choices and enhancing recovery.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (ChiCTR2500112657; registered on November 18, 2025).

01 Aug 2026·BIOCHEMICAL PHARMACOLOGY

Cipepofol attenuates endothelial barrier dysfunction in acute lung injury through DUSP1-dependent suppression of MAPK signaling

Article

Author: Xu, Xiaotao ; Ni, Xinzhe ; He, Xudong ; Zhou, Shuting ; Wang, Aizhong

Vascular endothelial cell dysfunction leads to the breakdown of endothelial barrier integrity, which contributes to sepsis-induced acute lung injury (ALI). The study investigates the role of Cipepofol in regulating endothelial permeability and inflammation during sepsis using a cecal ligation and puncture (CLP) mouse model and human umbilical vein endothelial cells (HUVECs). Our findings demonstrate that Cipepofol treatment inhibits cytoskeletal stress fiber formation and upregulates junction proteins VE-cadherin, thereby preserving endothelial barrier function. These effects were mediated through the γ-aminobutyric acid type A (GABA_A) receptor α1 subunit (GABA_A receptor α1). Cipepofol improved sepsis outcomes, including decreased lung injury, leukocyte infiltration, and vascular permeability. Mechanistically, cipepofol-dependent GABA_A receptor α1 modulated the expression of dual-specificity phosphatase 1 (DUSP1) in lung tissue and endothelial cells of septic mice. DUSP1 knockdown exacerbated p38 and extracellular signal-regulated kinase (ERK)-MAPK signaling and mitochondrial dysfunction, and abolished the protective effects of Cipepofol against lipopolysaccharide (LPS)-induced mitochondrial oxidative stress. Conversely, genetic or pharmacological inhibition of GABA_A receptor α1 reversed Cipepofol-mediated suppression of p38/ERK-MAPK signaling and reactive oxygen species (ROS) accumulation, confirming DUSP1 as a key downstream mediator. Together, our study unveils that Cipepofol preserves endothelial integrity by depending on GABA_A receptor α1 to modulate DUSP1 expression, thereby suppressing p38/ERK-MAPK signaling and mitochondrial dysfunction. These findings highlight a potential therapeutic strategy for sepsis-induced ALI.

01 May 2026·Digestive Endoscopy

Ciprofol May Represent a Useful Sedative Option for Gastrointestinal Endoscopy

Article

Author: Kawashima, Hiroki ; Yamamura, Takeshi ; Nakamura, Masanao

News (Medical) associated with Ciprofol

23 Jul 2026

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Haisco's Class 1 Innovative Drug Ciprocopan Succinate Tablets Approved in China, Offering a New Treatment Option for Patients With PNH

BEIJING, July 23, 2026 /PRNewswire/ -- Haisco Pharmaceutical Group claimed today their independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets (development code: HSK39297), has received marketing approval from the National Medical Products Administration of China (NMPA) for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are complement-inhibitor-naïve. This is Haisco's fifth innovative drug approved for marketing and represents an important advance in the treatment of complement-mediated diseases in China. As the world's first once-daily oral complement factor B (FB) inhibitor, Ciprocopan Succinate Tablets offers patients with PNH a new, safe and convenient treatment option. Continue Reading Focusing on Rare Diseases and Addressing Unmet Clinical Needs Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired clonal disorder of hematopoietic stem cells. The disease is primarily characterized by intravascular hemolysis, bone marrow failure, and venous thrombosis. Ongoing hemolysis may cause fatigue, renal impairment, pain, dyspnea, and other symptoms. Studies have shown that, before complement inhibitors became available, patients with PNH had a poor prognosis. Conventional management of PNH primarily includes supportive care, prevention and treatment of thrombosis, and allogeneic hematopoietic stem cell transplantation; immunosuppressive therapy may be used in patients with concomitant bone marrow failure. According to the Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition), treatment of PNH should be based on clinical subtype, and complement inhibitors are recommended as first-line therapy for classic PNH. Although advances in complement-targeted therapies have improved the treatment of PNH in recent years, patient needs remain largely unmet. C5 inhibitors can control intravascular hemolysis but do not block upstream complement activation. Some patients continue to experience residual anemia, fatigue, or a need for transfusions. Traditional twice-daily dosing regimens carry a risk of breakthrough hemolysis. Patients need new therapies that are effective, convenient, and suitable for long-term disease management. Ciprocopan Succinate Tablets is a highly potent and selective small-molecule complement factor B (FB) inhibitor developed independently by Haisco with full intellectual property rights. Using a structure-based approach, Haisco's R&D team identified opportunities for optimization and incorporated metabolically stabilizing groups to shield metabolic soft spots at the source. By targeting a key step in the alternative complement pathway, the compound inhibits both pathway initiation and the alternative-pathway-mediated amplification loop, thereby suppressing activation of the complement system and delivering therapeutic efficacy in complement-mediated diseases. As an innovative oral small-molecule therapy, Ciprocopan Succinate Tablets is administered once daily. No dosage adjustment is required in patients with mild or moderate renal impairment or in patients with mild, moderate, or severe hepatic impairment. No dosage adjustment is required when the product is coadministered with strong CYP2C8 inhibitors, and it may be taken without regard to food, improving treatment convenience and adherence. Advancing Innovation and Expanding the Innovative Medicine Portfolio Innovation is a core pillar of Haisco's strategy. From project initiation through clinical development, and from scientific exploration to successful commercialization, Ciprocopan Succinate Tablets represents a major milestone in Haisco's sustained investment in R&D and innovation. Guided by its innovation and globalization strategy and supported by the strong innovation ecosystem and biopharmaceutical industry environment in Sichuan Province and Chengdu, Haisco continues to increase investment in innovation. The company has built an R&D team of more than 1,000 professionals focused on key therapeutic areas, including anesthesia and pain management, chronic and metabolic diseases, gastrointestinal and liver diseases, respiratory diseases, autoimmune diseases, and oncology. Annual R&D investment has exceeded RMB 1 billion for several consecutive years, accelerating the translation of innovation into products. Haisco Pharmaceutical Group has established 5 modern manufacturing sites and more than 30 production lines across China to accelerate the industrialization of its innovative products. The Group has 27 Class 1 innovative drug programs and has established a tiered R&D pipeline spanning preclinical research and Phase I, Phase II, and Phase III clinical trials. Four Class 1 innovative drugs—Cipepofol Injection, Anrikefon, Cofrogliptin, and Crisugabalin—have received marketing approval, all of which are included in China's National Reimbursement Drug List (NRDL). Cipepofol Injection, an innovative intravenous anesthetic with independent intellectual property rights, received marketing approval from the U.S. Food and Drug Administration (FDA) in late May of this year. It is the first China-originated intravenous anesthetic new drug to enter the global market, marking a breakthrough from "new in China" to "new for the world". The successful approval and launch of Ciprocopan Succinate Tablets marks another breakthrough for Haisco in the frontier of global innovation in complement-mediated disease treatment and further enhances the company's innovative medicine portfolio. International Partnerships: Taking China-Originated Innovation Global Haisco is advancing its Innovation and Globalization Strategy 2.0, expanding its presence in global innovation markets, and continuously strengthening its international clinical development and global collaboration capabilities. Ciprocopan Succinate Tablets is also a key program in Haisco's globalization strategy. In June 2026, Haisco entered into an Exclusive License Agreement with U.S.-based Nuvectis Pharma, Inc., granting Nuvectis exclusive rights to develop, manufacture, and commercialize HSK42360 (a BRAF inhibitor) globally outside Greater China, as well as exclusive rights to develop, manufacture, and commercialize HSK39297 (the ciprocopan succinate program) globally outside Greater China, Southeast Asia, and India. As part of the consideration for the out-license transaction, Haisco will receive license payments for the HSK42360 and HSK39297 programs, including a total of $40 million in upfront and near-term milestone payments and up to $1.421 billion in additional milestone payments. Haisco will also be eligible to receive tiered royalties of up to double-digit percentages on future net product sales. Together, the companies will work to make these products available to more patients worldwide. In recent years, Haisco has accelerated its globalization efforts and entered into innovative drug R&D collaborations and international licensing agreements with several global pharmaceutical companies, including AbbVie, Eli Lilly, and Nuvectis, across key areas such as oncology and autoimmune diseases. These collaborations are helping bring China-originated innovative medicines to international markets. China's innovative drug R&D capabilities are gaining increasing global recognition. Looking ahead, Haisco will continue to pursue its innovation and globalization strategy, focus on major disease areas and unmet clinical needs, accelerate the development and global expansion of original innovative medicines, and further strengthen its independent innovation capabilities. The company aims to build an internationally competitive portfolio of innovative medicines, bring more China-originated therapies to patients worldwide, and contribute to the Healthy China initiative and global biopharmaceutical innovation. Further Reading [About Paroxysmal Nocturnal Hemoglobinuria (PNH)] Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired clonal disorder of hematopoietic stem cells. Acquired PIGA mutations in hematopoietic stem cells cause deficiencies in complement-regulatory proteins, including CD55 and CD59, and constitute the principal molecular basis of complement-mediated intravascular hemolysis in PNH. PNH is primarily characterized by intravascular hemolysis, bone marrow failure, and venous thrombosis. Ongoing hemolysis may cause fatigue, renal impairment, pain, dyspnea, and other symptoms. Studies have shown that, before complement inhibitors became available, patients with PNH had a poor prognosis. Conventional management of PNH primarily includes supportive care, prevention and treatment of thrombosis, and allogeneic hematopoietic stem cell transplantation; immunosuppressive therapy may be used in patients with concomitant bone marrow failure. According to the Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition), treatment of PNH should be based on clinical subtype, and complement inhibitors are recommended as first-line therapy for classic PNH. [Three Advances in the Clinical Benefits of Ciprocopan Succinate Tablets] Enabled by deuterium substitution technology, Ciprocopan Succinate Tablets delivers three major advances in clinical benefit for PNH. A head-to-head Phase III study in China showed a hemoglobin target-attainment rate of 59.5%, a hemoglobin increase of 48.35 g/L, and reduced transfusion requirements; 94.6% of patients were transfusion-free, helping conserve healthcare resources. The incidence of treatment-emergent adverse events (TEAEs) was lower, and no adverse events led to treatment discontinuation or study withdrawal; the product also offers convenient once-daily oral dosing and a prolonged half-life of 21–38 hours. [Selected Scientific Conference Presentations on Ciprocopan Succinate Tablets] Results from two Phase III clinical studies of Ciprocopan Succinate Tablets were accepted for presentation at the 2026 Congress of the European Hematology Association (EHA). One was a randomized controlled study in patients with PNH who were complement-inhibitor-naïve, and the other was a single-arm study in patients with persistent anemia despite stable treatment with a C5 monoclonal antibody. These two studies included a broad population of patients with PNH and both yielded positive results, demonstrating robust efficacy and a favorable safety profile. Once-daily oral monotherapy with Ciprocopan Succinate Tablets may provide sustained and comprehensive disease control for patients with PNH, together with a favorable safety profile and the potential for long-term treatment, underscoring its innovative value and global competitiveness in PNH care. [References] Red Blood Cell Diseases (Anemia) Group, Chinese Society of Hematology, Chinese Medical Association. Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition). Chinese Journal of Hematology, 2024, 45(8): 727-737. Hillmen P, Lewis SM, Bessler M, et al. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med, 1995, 333(19): 1253-1258. Dingli D. Improved therapy for paroxysmal nocturnal hemoglobinuria. Ann Blood. 2026;11:8. doi:10.21037/aob-2025-1-62 Xu G, et al. Efficacy and safety of switching to oral HSK39297 monotherapy in paroxysmal nocturnal hemoglobinuria patients with persistent anemia despite anti-C5 therapy: a phase 3 study (HSK39297-302). Presented at EHA 2026; Abstract PS1786. Phase III Clinical Study Report of HSK39297 Tablets Prescribing Information for Ciprocopan Succinate Tablets; Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310. Risitano AM, et al. Br J Haematol. 2022;196:288-303. Hillmen P, et al. N Engl J Med. 2006;355:1233-1243. Peffault de Latour R, et al. Blood. 2015;125(5):775-783.4. Panse J, et al. Value Health. 2023;26(Suppl):S468.. Dingli D, et al. Ann Hematol. 2022;101:251-263. Disclaimer: This material is intended to provide current medical information and research updates for healthcare professionals only. It is not intended for product promotion or advertising. The content herein is not a substitute for professional medical judgment and should not be construed as diagnostic or treatment advice. Healthcare professionals should refer to and strictly follow the most current full prescribing information when prescribing any product discussed herein. For the complete disclaimer, visit: . SOURCE Haisco Pharmaceutical Group Co., Ltd. 21% more press release views with Request a Demo

Clinical ResultPhase 3License out/inDrug ApprovalPhase 2

22 Jul 2026

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Haisco's Ciprofol Receives U.S. FDA Approval with CDMO Support from Jiuzhou Pharma

Jiuzhou Pharma Assists Client with U.S. FDA Approval of IV Anesthesia Zhejiang JiuZhou Pharmaceutical Co Ltd (SSE:603456.SH) Jiuzhou Pharma is honored to have partnered with Haisco throughout its journey to U.S. FDA approval.” — Jiuzhou Pharma, CDMO TAIZHOU CITY, ZHEJIANG, CHINA, July 22, 2026 / EINPresswire.com / -- On June 1, Haisco Pharmaceutical Group announced that its proprietary innovative intravenous anesthetic, Cipepofol Injection (CYPSEDO), received approval from the U.S. Food and Drug Administration (U.S. FDA) for the induction of general anesthesia in adults. The approval marks a significant milestone for Haisco, making Cipepofol the first innovative intravenous anesthetic developed in China to receive U.S. FDA approval. It also highlights the company's continued progress in advancing innovative medicines for global markets. Jiuzhou Pharma ’s End-to-End CDMO Support for Global Registration Following the U.S. FDA approval, Haisco shared the following message with the Jiuzhou Pharma team: "We are pleased to announce that our NDA has been approved by U.S. FDA. We sincerely appreciate Jiuzhou Pharma's outstanding support and close collaboration throughout the program." This milestone reflects a long-term commitment to innovation and strong collaboration between the two companies throughout development, manufacturing, quality, and regulatory activities. Jiuzhou Pharma is honored to have partnered with Haisco throughout its journey to U.S. FDA approval. Since 2019, Jiuzhou Pharma has supported the global development of the Cipepofol program as Haisco’s CDMO partner, providing end-to-end services including GMP manufacturing of clinical and registration API batches, quality risk assessment, and regulatory support. To meet the project’s dedicated manufacturing requirements and stringent U.S. FDA expectations, Jiuzhou Pharma integrated cross-functional teams to ensure manufacturing readiness, consistent quality, and timely batch delivery, enabling the program to progress efficiently toward U.S. regulatory approval. Accelerating Innovation from Development to Commercial Supply As an end-to-end CDMO partner, Jiuzhou Pharma provides integrated services spanning process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches, and commercial supply, backed by a robust quality management system and proven project execution capabilities. Jiuzhou Pharma engages in continuous assessment and growth to strengthen its integrated CDMO capabilities and global delivery network to help pharmaceutical innovators accelerate drug development, global regulatory approvals, and commercial supply. About Jiuzhou Pharma Founded in 1973, Jiuzhou Pharma (SSE: 603456) is an innovation-driven global CDMO providing integrated drug development and manufacturing solutions for pharmaceutical companies, biotechnology companies, and research institutions worldwide. With ten manufacturing sites, seven R&D centers, and end-to-end capabilities spanning process development, GMP manufacturing, and commercial supply, Jiuzhou Pharma supports small molecules, peptides, antibody-drug conjugates (ADCs), and oligonucleotide therapeutics across the product lifecycle. Guided by its mission of "Caring for Life, Safeguarding Health," Jiuzhou Pharma is committed to helping customers accelerate drug development and commercialization, bringing innovative medicines to patients worldwide. JiuZhou Pharma is the parent company of Raybow USA, Inc. , located in Brevard, North Carolina, USA. About Haisco Pharmaceutical Group Haisco Pharmaceutical Group (SZSE: 002653) is an international pharmaceutical company engaged in the discovery, development, manufacturing and commercialization of pharmaceutical products. The company focuses on therapeutic areas including anesthesia and pain management, metabolic diseases, respiratory and autoimmune disorders, neuroscience and oncology. Haisco has built a diversified pipeline covering innovative small molecules, biologics and high-value generics, with multiple clinical-stage programs and several commercialized innovative products. Through continuous innovation and global expansion, the company is committed to delivering differentiated therapeutic solutions to patients worldwide. ### Nathaniel Kim, PhD Jiuzhou Pharma email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

01 Jun 2026

·www.prnewswire.com

China's Original Innovative Drug Cipepofol Approved for Marketing by the U.S. FDA

BEIJING, June 1, 2026 /PRNewswire/ -- Cipepofol (CYPSEDO) Injection (hereinafter "Cipepofol"), a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group, has officially received marketing approval from the U.S. Food and Drug Administration (FDA), becoming the first China-originated innovative intravenous anesthetic to enter the global market. This milestone marks the moment a China-originated innovative drug, backed by outstanding breakthroughs and robust clinical evidence, has officially opened the door to the global high-standard pharmaceutical market and secured its entry ticket. Intravenous anesthetics are the cornerstone of clinical surgeries and intensive care. For decades, clinical challenges associated with intravenous anesthesia—such as injection pain and respiratory depression—have remained persistent obstacles that the global pharmaceutical research community has strived to overcome. Cipepofol (Chinese trade name: Sishuning) is China's first independently developed Class 1 innovative intravenous anesthetic with global independent intellectual property rights. It has been approved in China for sedation and anesthesia in non-tracheal intubation surgeries/procedures, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in the intensive care unit. In September 2025, its approval was further expanded to include the induction and maintenance of general anesthesia in children and adolescents. The development of Cipepofol dates back to 2012. Haisco's R&D team tackled numerous challenges to refine the molecular structure. By introducing a chiral cyclopropyl group and conducting thousands of screenings and safety evaluations, they successfully developed a Class 1 new drug that demonstrated favorable efficacy and safety profiles. Results from clinical studies conducted both domestically and internationally showed that, while retaining the advantages of rapid onset and complete recovery, Cipepofol significantly reduced the incidence of intraoperative respiratory depression and cardiovascular adverse reactions, as well as injection pain. With a lower risk of respiratory depression, more stable hemodynamics, milder injection pain, and individualized care for elderly and pediatric patients, Cipepofol not only makes "comfortable treatment" more compassionate—directly addressing patients' desire for a pain-free anesthesia induction and reducing their fear of surgery—but also substantially enhances the comfort and safety of the diagnosis and treatment process on both physiological and psychological levels, while greatly improving the accuracy and success rate of physicians' diagnoses and treatments. In December 2020, Cipepofol was officially approved for marketing by the National Medical Products Administration (NMPA), ushering in a new chapter in clinical comfortable anesthesia. Subsequently, multiple indications were approved in succession, including induction of general anesthesia, fiberoptic bronchoscopy, and sedation during intensive care. In September 2025, the dosage and administration for the induction and maintenance of general anesthesia in children and adolescents were approved, further broadening its clinical application scenarios. As of May 2026, Cipepofol has been incorporated into the recommendations of over 20 guidelines and consensus documents, as well as into textbooks for higher education under China's 14th Five-Year Plan, and has been included in the National Reimbursement Drug List (NRDL). To date, it has been adopted by over 3,300 medical institutions, cumulatively benefiting more than 40 million patient visits. The internationalization journey of Cipepofol epitomizes the shift from "Made in China" to "Innovated in China". After receiving FDA clearance to conduct clinical trials in 2021, Cipepofol was granted a waiver for Phase II trials in the United States and advanced directly to pivotal Phase III trials. All clinical studies were completed in 2024, yielding superior results in a head-to-head comparison against the standard of care. In July 2025, driven by its exceptional innovative strength and solid clinical evidence, the New Drug Application (NDA) for Cipepofol was formally accepted by the U.S. FDA. The successful U.S. FDA marketing approval of Cipepofol (CYPSEDO) stands as a powerful testament to the overseas capabilities of Chinese pharmaceutical enterprises. Seizing the opportunity presented by the FDA approval of Cipepofol (CYPSEDO), Haisco is actively advancing its commercialization in the United States and other regions through collaborations. The company will also consider initiating a marketing authorization application in Europe at an appropriate time, delivering high-quality solutions originating from Chinese innovative drugs to the world and benefiting more global patients. About Haisco Haisco is an international pharmaceutical enterprise integrating research and development, manufacturing, and sales (Stock Code: 002653.SZ). Focusing on therapeutic areas such as anesthesia and analgesia, chronic metabolic diseases, respiratory and autoimmune diseases, neurological systems, and oncology, the company adheres to an innovation and globalization strategy. With the vision of "striving to become the most trusted international pharmaceutical enterprise", it aims to meet unmet clinical needs and care for patients worldwide. Currently, Haisco Pharmaceutical Group has established a series of diversified R&D pipelines with independent intellectual property rights, covering small-molecule innovative drugs, biologics, and high-end generics. Multiple projects are in the clinical development stage, and several innovative drugs have been commercialized, providing diversified innovative product solutions globally. Appendix: Background Information on CYPSEDO (cipepofol) I. Published SCI Papers Related to CYPSEDO (cipepofol) with Impact Factor >6 Ni T, Zhou X, Wu S, et al. Hemodynamic Impact of Cipepofol vs Propofol During Anesthesia Induction in Patients With Severe Aortic Stenosis: A Randomized Clinical Trial. JAMA Surg. 2025;14.9(IF). Yu Y, Deng J, Yin Y,et al. Ciprofol vs propofol for gastrointestinal endoscopy sedation: a systematic review and meta-analysis. Int J Surg. 2025;10.1(IF). He ZZ, Liang JY, Duan JX, et al. Ciprofol versus propofol sedation in ICU patients and norepinephrine requirements: a single-center prospective cohort study. Crit Care. 2025;9.3(IF). Gan TJ, Bertoch T, Habib AS, et al. Comparison of the efficacy of HSK3486 and propofol for induction of general anesthesia in adults: a multicenter, randomized, double-blind, controlled, phase 3 noninferiority trial. Anesthesiology. 2024;9.1(IF). Liu YJ, Peng Z, Liu S, et al. Efficacy and safety of ciprofol sedation in ICU patients undergoing mechanical ventilation: A multicenter, single-blind, randomized, noninferiority trial. Crit Care Med. 2023;8.3(IF). Liu YJ, Zuo LY, Li XY, et al. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024;7.8(IF). Qin LL, Ren L, Wan SL, et al. Design, synthesis, and evaluation of novel 2,6-disubstituted phenol derivatives as general anesthetics. J Med Chem. 2017;7.3(IF). Liang P, Dai M, Wang X, et al. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023;6.8(IF). Ding YY, Long YQ, Yang HT, et al. Efficacy and safety of ciprofol for general anaesthesia induction in elderly patients undergoing major noncardiac surgery: A randomised controlled pilot trial. Eur J Anaesthesiol. 2022;6.8(IF). Liu YJ, Yu XY, Zhu DM, et al. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J. 2022;6.1(IF). II. International Academic Conferences Where CYPSEDO (cipepofol) Was Presented ISAP 31st Annual Meeting - 2022 - Poster WCA - 2024- Lecture & LBA ePoster & ePoster ESA Annual Meeting - 2024 - ePoster JSA Annual Meeting - 2024 - Poster ASA Annual Meeting - 2025 - Oral & ePoster ESICM LIVES - 2024 - Poster ESA Annual Meeting - 2025 - Lecture & ePoster SCCM Critical Care Congress - 2025 - Poster ESICM LIVES - 2025 - Oral & Poster AACA Annual Meeting - 2025 - Lecture ESA Annual Meeting - 2026 - ePoster III. Clinical Guidelines and Consensus Statements Incorporating CYPSEDO (cipepofol) Expert Consensus on Sedation/Anesthesia for Bronchoscopy (2020 Edition), 2020, Chinese Society of Anesthesiology Chinese Expert Consensus on Sedation/Anesthesia for Digestive Endoscopy (2020 Edition), 2020, Anesthesia Collaborative Group of the Chinese Society of Digestive Endoscopy Guidelines for Anesthesia in Ambulatory Surgery (2023 Edition), 2023, Chinese Society of Anesthesiology Expert Consensus on Out-of-Operating Room Anesthesia/Sedation in Elderly Patients (2023 Edition), 2023, Journal of Clinical Anesthesiology Guidance on Sedation and Anesthesia Protocols for Diagnostic and Therapeutic Procedures (2023 Edition), 2023, Chinese Society of Anesthesiology Expert Consensus on Analgesia and Sedation in Patients with Severe Neurological Diseases (2023 Edition), 2023, Expert Group on Analgesia and Sedation for Severe Neurological Diseases Diagnostic and Therapeutic Process for Analgesia and Sedation in Adult Critically Ill Patients, 2023, Chinese Journal of Critical Care Medicine (Electronic Edition) Expert Consensus on Data Elements and Definitions for Analgesia and Sedation in Adult Critically Ill Patients (2023 Edition), 2023, Expert Group on Data Elements and Definitions for Analgesia and Sedation in Adult Critically Ill Patients Expert Consensus on Post-Intensive Care Management (2023 Edition), 2023, Chinese Society of Critical Care Medicine Standards for Diagnosis and Treatment of Non-Neonatal Tetanus (2024 Edition), 2024, General Office of the National Health Commission Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition), 2024, Chinese Society of Anesthesiology Chinese clinical practice guidelines for total intravenous anaesthesia:a systematic review and expert consensus-based recommendations，2025，e Chinese Society of Anaesthesiology of the Chinese Medical Association. Expert Consensus on Medication Adjustment During ECMO Support (2025), 2025, Critical Care Medicine Committee of China International Exchange and Promotive Association for Medical and Health Care, Hospital Pharmacy Committee of Chinese Pharmaceutical Association Expert Recommendations for Out-of-Operating Room Anesthesia/Sedation in Patients with Obesity, 2025, Task Force on "Expert Recommendations for Out-of-Operating Room Anesthesia/Sedation in Patients with Obesity" Expert Consensus on Anesthesia Management for ERCP (2025), 2025, Chinese Society of Digestive Endoscopy, Anesthesiology Branch of Chinese Geriatrics Society Expert Consensus on the Use of Intravenous Anesthetics for Refractory Insomnia Disorder, 2025, Psychiatric Health Branch of Sichuan Preventive Medicine Association, Sleep Medicine Committee of Sichuan Geriatrics Society Emergency Expert Consensus on Diagnosis and Treatment of Sepsis-Associated Encephalopathy in the Elderly, 2025, Emergency Medicine Branch of Chinese Medical Association, Emergency Branch of Chinese Geriatrics Society, Emergency Medicine Branch of Beijing Medical Association Expert Consensus on Analgesia, Sedation, and Delirium Management in Adult Patients Receiving Extracorporeal Membrane Oxygenation (2025 Edition), 2025, Extracorporeal Life Support Committee of Chinese Medical Doctor Association, Chinese Society of Anesthesiology Expert Consensus on the Application of Drug-Induced Sleep Endoscopy in the Diagnosis and Treatment of Obstructive Sleep Apnea (2025 Edition), 2025, Sleep Breathing Disorders Working Committee of the Respiratory Physician Branch of Chinese Medical Doctor Association Clinical Practice Guideline for the Use of Intravenous Anesthetics (2025 Edition), 2025, Anesthesiologist Branch of Chinese Medical Doctor Association Chinese Guidelines for Sedation and Anesthesia Management During Digestive Endoscopy (2026 Edition), 2026, Chinese Society of Digestive Endoscopy / Chinese Society of Anesthesiology SOURCE Haisco 21% more press release views with Request a Demo

Drug ApprovalPhase 2Phase 3NDA

100 Deals associated with Ciprofol

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N05C	DB16295

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Haisco Pharmaceutical Group Co., Ltd.	29 May 2026
Anesthesia	United States	-	29 May 2026
Sedation	China	Shenyang Haisike Pharmaceutical Co., Ltd.	11 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Arrhythmias, Cardiac	Phase 1	China	Haisco Usa Pharmaceuticals, Inc.	09 Apr 2024
Chronic Kidney Diseases	Phase 1	China	Haisco Pharmaceutical Group Co., Ltd.	12 Nov 2019
Chronic liver disease	Phase 1	China	Haisco Pharmaceutical Group Co., Ltd.	07 Nov 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05518929 (Pubmed \| Dig Endosc)	Phase 4	Hypoxia	1,018	Ciprofol	hwxzhasmxc(ebvzkuwafk) = pdkgytgzhw ssfeeggpkt (swpxpbcqun ) View more	Positive	01 Feb 2026
				Propofol	hwxzhasmxc(ebvzkuwafk) = srwfhqxbox ssfeeggpkt (swpxpbcqun ) View more
NCT06795204 (CTgov)	Phase 1	Arrhythmias, Cardiac	48	HSK3486 (HSK3486( Study Drug))	fihmzlinow(akxzdrftkp) = aijsajxihn sewymzhavm (pkjirrkeby, xnkvwqtskm - ignflxtyjf) View more	-	13 Jan 2026
				Placebo (Placebo)	fihmzlinow(akxzdrftkp) = oaxnxdcvyo sewymzhavm (pkjirrkeby, xvobzzwcuw - xactxlghiy) View more
NCT06172140 (Pubmed \| Ann Med)	Not Applicable	-	124	Ciprofol	nghhwljgvk(kzqquwhrqm) = sfjmpfnknx acispbwciy (uxxcpxngsv ) View more	Positive	31 Dec 2025
				Propofol	nghhwljgvk(kzqquwhrqm) = thqgjswkvz acispbwciy (uxxcpxngsv ) View more
NCT05486416 (CTgov)	Phase 3	Anesthesia	465	HSK3486 (HSK3486 for General Anesthesia Induction)	grnoesuzjj = byapdztwrm yamapsjzos (xtyooclclz, vhsrcirxuz - vkfmwrprxg) View more	-	11 Aug 2025
				Propofol (Propofol for General Anesthesia Induction)	grnoesuzjj = trvhcfaxqm yamapsjzos (xtyooclclz, ukywehjcym - oipchusctb) View more
NCT05522998 (Pubmed \| PLoS One)	Phase 4	Obesity	212	Ciprofol 0.5 mg/kg	wspyovytmz(eibhngnnxt) = qdwrkzpqnb iwulcmywjc (crbhpkymuk ) View more	Positive	24 Jul 2025
				Propofol 2.5 mg/kg	wspyovytmz(eibhngnnxt) = xqmgnqiflk iwulcmywjc (crbhpkymuk ) View more
NCT06287138 (Pubmed \| Front Med (Lausanne))	Not Applicable	-	20	Cipepofol	fkfxaqkfrr(igfhbxhmkg) = reductions in P0.1 (p = 0.020) were significant bmqepyzkao (urlmcokdaq ) View more	Positive	25 Feb 2025
ChiCTR2100047580 (Pubmed \| BMC Anesthesiol)	Phase 1	Gastrointestinal Neoplasms	30	Ciprofol	dctxksudqm(mjyoeuuodo) = xfkhphgfys ivfjmocydh (ciebbmahwu, 900.0) View more	Positive	27 Jan 2025
				Propofol	lapclwpria(cnkoauwflu) = xtxqiaibqd eguvuygkgw (xzppaekfis ) View more
NCT06413862 (Pubmed \| BMC Anesthesiol)	Not Applicable	-	217	Ciprofol combined with alfentanil	zirhkbresc(xqtuxcthjq) = crdagotxrb uuwretjutx (sdshfpwxhd ) View more	Positive	12 Nov 2024
				Propofol combined with alfentanil	zirhkbresc(xqtuxcthjq) = khvelevgbi uuwretjutx (sdshfpwxhd ) View more
NCT05478174 (CTgov)	Phase 3	Anesthesia	400	HSK3486 (HSK3486)	zektnbwumd = sggnqvqwup egjpdzadls (xxmlebqppw, kexycwwmap - ugnyckehff) View more	-	29 Oct 2024
				Propofol (Propofol)	zektnbwumd = osewbwghgl egjpdzadls (xxmlebqppw, bdhebhogew - zwrqcttllm) View more
ChiCTR2300070088 (Pubmed \| J Cardiothorac Vasc Anesth)	Phase 4	-	112	Ciprofol	rxioyrfyfc(qscylwasit) = jtvndnbcpa olicdoblns (zbgwheczzb, -18.0 to -16.6)	Positive	01 Oct 2024
				Propofol	rxioyrfyfc(qscylwasit) = dejkjxzecp olicdoblns (zbgwheczzb, -18.7 to -17.0)

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