Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

开始日期2025-07-01

申办/合作机构-

NCT07034963

/ Recruiting临床1/2期IIT

Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care

Cervical dilation-induced somatic responses remain a critical challenge in ambulatory hysteroscopic surgery. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, exhibits unique analgesic and sedative properties that may enhance perioperative somatic response inhibition. However, the effective dose of esketamine under dexmedetomidine-remifentanil based monitored anesthesia care (MAC) during ambulatory hysteroscopic surgery remains to be determined. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for cervical response suppression. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.

开始日期2025-07-01

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

NCT07034950

/ Recruiting临床1/2期IIT

Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade

Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Esketamine, an N-methyl-D-aspartate receptor antagonist, exhibits unique dual analgesic-sedative properties that may address this therapeutic gap, thus obviating the necessity for opioids. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for opioid-free analgesia during ultrasound-guided thermal ablation of liver tumors under HHNB. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.

开始日期2025-07-01

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

100 项与盐酸艾司氯胺酮相关的临床结果

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100 项与盐酸艾司氯胺酮相关的转化医学

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100 项与盐酸艾司氯胺酮相关的专利（医药）

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2,495

项与盐酸艾司氯胺酮相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Respiratory depression in women receiving propofol/esketamine versus propofol/fentanyl for abortion surgery or curettage: a randomized clinical trial

Article

作者: Chen, Huihe ; Luo, Jiaxin ; Guan, Xuehai ; Wu, Xiaoshan ; Cao, Huiyu ; Lan, Hongmeng ; Lin, Yuliu ; Zhang, Cuiwen ; Liao, Yeqing ; Huang, Xiaofang

BACKGROUND:

A combination of opioids with propofol is a popular approach to non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression. We compared the incidence of esketamine- and fentanyl-induced respiratory depression in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

METHODS:

This study included 176 women (aged 18-60 years) scheduled for abortion surgery or curettage. Patients were randomized into the fentanyl or esketamine groups. Patients in the fentanyl group received fentanyl (1 µg/kg) combined with propofol intravenously. Patients in the esketamine group received subanaesthetic doses of esketamine (0.15 mg/kg) combined with propofol intravenously. The primary outcome was the incidence of respiratory depression during anaesthesia. Secondary outcomes included respiratory rate, pulse oximetry, blood pressure, heart rate, propofol dose, duration of surgery, duration of anaesthesia, and adverse events.

RESULTS:

The incidence of respiratory depression in the esketamine group was significantly lower than that in the fentanyl group (11% vs. 45%; p < .0001). Propofol administration was lower with esketamine than fentanyl. Respiratory rate, SpO₂ and blood pressure were more stable in the esketamine group than in the fentanyl group. The incidences of hypotension, propofol-induced injection pain and chin lifting in the esketamine group were lower than those in the fentanyl group. The incidence of nightmares was higher in the esketamine than in the fentanyl group.

CONCLUSIONS:

The incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.KEY MESSAGESOpioids combined with propofol is a popular method for non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression.At subanaesthetic doses, esketamine provides an analgesic effect by antagonizing the N-methyl-d-aspartate receptor.In this trial, the incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

2025-12-31·ANNALS OF MEDICINE

Opioid-free anaesthesia to reduce postoperative nausea and vomiting after lower extremity wound surgery: a randomised double-blind crossover trial

Article

作者: Liu, Hua-yue ; Qian, Long ; Ying, Yao-yu ; Zhu, Ya-juan ; Ji, Fu-hai ; Liu, Hong ; Peng, Ke

BACKGROUND:

Postoperative nausea and vomiting (PONV) are common complications after surgery. Opioid use is a significant risk factor. We utilised a crossover design to test this hypothesis in the same individuals that opioid-free anaesthesia (OFA) compared with opioid-inclusive anaesthesia reduces PONV.

METHODS:

This randomised double-blind crossover trial included adult patients undergoing two surgical procedures for lower extremity wounds under general anaesthesia. Each patient received both OFA (i.v. lidocaine, esketamine, dexmedetomidine and propofol) and opioid-inclusive anaesthesia (sufentanil and propofol); which came first was determined by randomisation. The primary outcome was the incidence of PONV during the first 48 h postoperatively. Secondary outcomes were the severity of PONV, use of rescue antiemetics, postoperative pain, need for rescue analgesia, adverse events, time to extubation, and length of recovery room stay.

RESULTS:

Sixty-six patients completed this study (mean age 53 years, 36% female). The median washout period was 9 days. Compared with opioid-inclusive anaesthesia, OFA reduced the incidence of PONV 0-48 h postoperatively (5% vs. 23%, odds ratio [OR] = 0.13, 95% CI: 0.03-0.55, p = 0.006), which remained significant in the prespecified adjusted analysis (OR = 0.06, 95% CI: 0.01-0.32, p = 0.001). OFA also led to a reduced severity of PONV, a lower rate of hypotension, and a longer time to extubation. Postoperative pain and other outcomes were similar between the two anaesthetic techniques.

CONCLUSION:

This crossover trial demonstrates that OFA reduced PONV following lower extremity wound surgery, providing compelling evidence for the administration of OFA to enhance perioperative care.

REGISTRATION:

ChiCTR2200061511 (https://www.chictr.org.cn).

2025-12-31·ANNALS OF MEDICINE

Effects of esketamine infusion on tourniquet-induced hypertension in patients undergoing below-knee orthopedic surgery: protocol for a randomized controlled trial

Article

作者: Ying, Yao-yu ; Shi, Hai-jing ; Ji, Fu-hai ; Jiang, Kai ; Peng, Ke ; Zhuang, Min-yuan ; Zhao, Wen-qian

INTRODUCTION:

Application of a tourniquet reduces surgical bleeding while causing pain and tourniquet-induced hypertension (TIH). Deeper anesthesia and additional opioids are often insufficient to mitigate TIH but are associated with prolonged recovery and complications. Herein, we describe the protocol for a clinical trial investigating whether intraoperative esketamine infusion would reduce the rate of TIH during below-knee orthopedic surgery.

PATIENTS AND METHODS:

This prospective, randomized, double-blind, controlled trial will include a total of 80 adults scheduled for below-knee orthopedic surgery under general anesthesia. Patients will be randomly assigned in a 1:1 ratio to receive either esketamine infusion at 0.25 mg/kg/h or normal saline infusion after anesthesia induction and during tourniquet inflation. Both groups will receive ultrasound-guided unilateral popliteal sciatic nerve block and adductor canal block with 0.25% ropivacaine. The primary outcome is the occurrence of TIH, defined as an increase in systolic blood pressure >30% of baseline during tourniquet inflation. Secondary outcomes include the incidence of hypotension during surgery; intraoperative hemodynamic changes; intraoperative opioid dose and total amount of esmolol; postoperative nausea and vomiting, dizziness, and mental side effects; postoperative pain at 1, 6, 12, and 48 h after surgery; postoperative analgesic consumption within 48 h after surgery; and length of postoperative hospital stay. Additionally, we will assess patients' quality of recovery at 24 h after surgery.

DISCUSSION:

This trial will determine the effects of esketamine infusion on TIH in patients who undergo below-knee orthopedic surgery under general anesthesia. Our results will offer a new insight into optimizing anesthetic care for surgical patients receiving tourniquet.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (ChiCTR2400081237).

524

项与盐酸艾司氯胺酮相关的新闻（医药）

2025-06-23

·BioPharmaDive

Compass’ big psychedelic study doesn’t impress investors

One of the most closely watched clinical trials in the burgeoning field of psychedelics research has delivered results that, while positive, appear to have unnerved some investors.Sponsored by U.K.-based biotechnology company Compass Pathways, the trial enrolled 258 people with treatment-resistant depression. Participants were given either a placebo or the companys proprietary version of psilocybin a psychedelic compound found in many mushroom species and evaluated for an initial period of six weeks.According to Compass, a single dose of its drug significantly reduced scores on a 60-point scale healthcare providers use to gauge depressive symptoms.Specifically, the drug arm showed a 3.6-point larger decline on that scale compared to its placebo counterpart. Compass also said an independent group of experts reported that the drugs safety looks consistent, with no unexpected findings in this study or another ongoing, late-stage trial. That group has not observed any clinically meaningful imbalance in suicidality between the treatment arms in either experiment.In a statement, Guy Goodwin, Compass chief medical officer, said the company is very encouraged by the new data, which mark an important milestone for patients whose depression hasnt been adequately treated through multiple approved options. This achievement provides hope that they can finally receive appropriate care and live the life they deserve.Investors, though, didnt seem as enthused. Compass shares were down by nearly 50% Monday morning, to trade below $3 apiece.Leonid Timashev, an analyst at RBC Capital Markets, noted how in earlier testing, patients on Compass drug experienced a roughly 6-point reduction on that depression severity scale. The RBC team also spoke to important doctors in the depression field, who, while open to using any effective agents, said a 4-point-or-more decline would be the bar to aim for.Shareholders therefore wanted to see a separation at least somewhere in the middle, around 5 points, according to Timashev. They were likely disappointed, then, by the readout as well as Compass release, which contained no details on response rates, remission rates or the drugs lasting power. Those are important details investors may be looking for to gauge the drug's competitive profile, the analyst wrote in a note to clients.While some may be underwhelmed, Timashevs team still views the results as clinically meaningful and in a range that could make Compass drug competitive with Johnson & Johnsons Spravato. That latter medicine, a form of ketamine taken as a nasal spray, won U.S. approval for treatment-resistant depression in 2019. Its since become one of J&Js faster-growing products, fetching nearly $1.1 billion in sales last year.Timashev argued that, at a single dose, Compass drug could hold significant convenience advantages. It might also look better than Spravato at certain time points in their respective studies though cross-trial comparisons are tricky.Evercore ISI analyst Gavin Clark-Gartner took a much less bullish stance and downgraded his stock rating on Compass. With clinical and commercial question marks, the second [Phase 3 study] will remain a show me story for investors in an increasingly competitive landscape, he wrote.To that end, a small, Ireland-based developer recently reported results from a study testing an inhaled version of mebufotenin, a molecular cousin to psilocybin. The 81-person trial found GH Researchs drug to be a fast and effective therapy for treatment-resistant depression, delivering an almost 16-point drop on that scale compared to a placebo.Paul Matteis, an analyst at Stifel who covers both Compass and GH Research, highlighted in his own note the very significant differences between the two companies trials. The main measure in the latters, for example, was taken at the eight-day mark. That study also employed a titration regimen Matteis team believes played a part in attenuating any placebo response.Placebo responses are a major obstacle in psychiatric and psychedelic experiments, so anything that mitigates them could potentially benefit the results.Compass expects to share 26-week results from its other ongoing late-stage trial in the back half of next year. '

临床结果临床3期上市批准

2025-06-10

·GlobeNewswire-Health Care

Neuronetics Announces Clinical Presence at the 2025 Clinical TMS Society Annual Meeting and Progress in Greenbrook’s Personalized Care Trial Program

NeuroStar, a Silver Sponsor at CTMSS, will also present two posters as part of the Company’s ongoing commitment to clinical innovation and excellenceMALVERN. Pa., June 10, 2025 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a vertically integrated, commercial stage, medical technology and healthcare company with a strategic vision of transforming the lives of patients whenever and wherever they need help, is proud to share two significant updates underscoring its ongoing commitment to clinical excellence and innovation in mental health care. This week, NeuroStar will attend the 13th Annual Clinical TMS Society (CTMSS) Meeting, taking place June 11–14 in San Diego, CA as a Silver Sponsor. NeuroStar will present two poster presentations derived from the TrakStar® data set, the largest real-world outcomes database in TMS. Data highlights include a retrospective analysis of Greenbrook’s multi-site study, providing a direct comparison of clinical outcomes between NeuroStar’s proprietary Figure-8 coil and Brainsway’s H-coil in the treatment of depression, offering new insight into device-specific performance. As part of the meeting, the Company will participate in the PULSES Course, a foundational training session for new and experienced TMS providers. Additionally, NeuroStar will exhibit at booth #303. “The data and research initiatives reflect the scientific excellence NeuroStar is known for and are a continuation of our reputation as the leader in contributing to the scientific literature in the psychiatric community,” said Cory Anderson, Chief Technology Officer of Neuronetics. “We will continue to lead the field and put patient outcomes first by investing in valuable research to optimize TMS efficacy and expand its use into new populations and protocols.” The following data will be presented at the CTMSS Meeting: Age is Just a Number: Real-world effectiveness of TMS in late-life depression Presenter: Dr. Eleanor Cole, Senior Director of Clinical Innovation, Neuronetics Inc.Overview: Dr. Cole will present the largest-to-date analysis of elderly adults (age 70 and older) with Major Depressive Disorder (MDD) treated with TMS.Presentation Date: June 13th at 4:00 PM PDT Clinical Outcomes in Patients Treated with NeuroStar and Brainsway TMS Therapy Devices Presenter: Cory Anderson, Chief Technology Officer, Neuronetics Inc.Overview: Mr. Anderson will present data from a retrospective analysis of data from 200 Greenbrook centers evaluating the real-world efficacy of TMS therapy delivered using NeuroStar or Brainsway devices.Presentation Date: June 13th at 4:00 PM PDT Greenbrook Mental Wellness Centers, a wholly owned subsidiary of Neuronetics, has initiated a program to evaluate the feasibility of using personalized qEEG-informed protocols to deliver TMS therapy using the NeuroStar TMS System. To date, the program has demonstrated operational feasibility and the ability to successfully deliver the protocols using a commercially available NeuroStar TMS System. The Company looks forward to sharing their findings in the near future. For more information about NeuroStar TMS Therapy, please visit www.neurostar.com. About Neuronetics Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is delivering more treatment options to patients and physicians by offering exceptional in-office treatments that produce extraordinary results. NeuroStar Advanced Therapy is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, Neuronetics operates Greenbrook TMS Inc. (Greenbrook) treatment centers across the United States, offering NeuroStar Advanced Therapy for the treatment of MDD and other mental health disorders. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults, with more than 7.4 million treatments delivered, and is backed by the largest clinical data set of any TMS treatment system for depression, including the world’s largest depression outcomes registry. Greenbrook treatment centers also offer SPRAVATO® (esketamine) Nasal Spray, a prescription medicine indicated for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. It is also indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.1 Greenbrook has provided more than 1.8 million treatments to over 55,000 patients struggling with depression. The NeuroStar Advanced Therapy System is cleared by the U.S. Food and Drug Administration for adults with MDD, as an adjunct for adults with obsessive-compulsive disorder, to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression), and as a first line adjunct for the treatment of MDD in adolescent patients aged 15-21. For safety information and indications for use, visit NeuroStar.com. Neuronetics Contact:Investors:Mike Vallie or Mark KlausnerICR Healthcare443-213-0499ir@neuronetics.com Media:EvolveMKD646.517.4220NeuroStar@evolvemkd.com 1 The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. For more important safety information about SPRAVATO®, please visit spravatohcp.com.

2025-06-07

·同写意

巨头药企，砸了上千亿

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！随着生物医药并购、BD持续高涨，跨国巨头作为“收割者”的形象似乎越发牢固。虽然Biotech贡献了更多原始创新已成为定论，但这不意味着MNC就在新药开发方面乏善可陈。Evaluate Pharma最新报告显示，2024年全球制药行业的研发支出增长1.5%，其中，来自MNC的资金占据大半。考虑到2023年整体研发预算飙升了11.5%，以行业自身的标准来看，2024年的1.5%属于一个相对温和的增幅。尽管如此，去年用于新药开发的资金规模仍然令人震惊：全球药企在研发方面投入了近2880亿美元。众所周知，从Lipitor、Humira再到今天的“药王”Keytruda，无论多么成功的“重磅炸弹”，都有其专利时限。如果药企不持续投入研发资金，产品组合得不到更新，那么“专利悬崖”带来的压力就将是实打实的“刀刀见血”——营收减少、股价下滑乃至需要裁员重组。直接买资产固然是条快捷通道，然而归根结底，这仍需要有人来完成“从0到1”的工作。因此，Evaluate Pharma预计，到2030年，该行业的研发开支将继续增加，达到3400亿美元左右。不确定之处在于，制药行业的研发支出模式可能面临越来越不稳定的外部环境。例如，美国特朗普政府正在推动的“最惠国定价”政策会导致药企在美国市场的收入骤减，进而影响可用的研发资金。分析师认为，制药公司可能更加注重对管线的排序，优先考虑盈利能力更强、竞争优势更大的研发项目。换言之，把握这些“金主”的动向，某种程度就是在捕捉未来的创新机会。下文将就2024年制药行业研发支出排名前五的MNC进行梳理。TONACEA01默沙东 2024年研发支出：179亿美元同比变化：-41%对于默沙东而言，2023年是一个耗资不菲的交易大年。这家巨头先是与Proxygen达成一项最高25.5亿美元的分子胶开发合作协议，随后宣布斥资108亿美元收购免疫药物开发商Prometheus Biosciences、以30亿美元收购新锐眼科公司EyeBio，下半年又以40亿美元的预付款、总计220亿美元的对价获得第一三共旗下三种ADC的授权许可。由于2023年的研发资金特别庞大，2024年默沙东的研发支出同比减少41%，更像是对预算的合理调整。事实上，它仍以179.4亿美元的巨额投资领先于其MNC，相当于其总收入的28%。不惜成本的砸钱，很直接的因素是“现金牛”Keytruda即将迎来专利到期，默沙东不得不大开发力度，以弥补这款“药王”留下的约300亿美元营收缺口。根据默沙东披露的信息，一些值得密切的研发管线，包括约20种潜在的“重磅炸弹”，未来有望给其带来超过500亿美元的回报。其中，包括ifinatamab deruxtecan，这款ADC靶向一种在多种癌症中过表达的跨膜蛋白B7-H3。默沙东正在进行一项III期临床（IDeate-Esophageal01研究），测试该药在晚期或转移性食管鳞状细胞癌中的疗效。Ifinatamab deruxtecan也有望用于治疗已接受过大量治疗的晚期小细胞肺癌，目前该适应症正处于后期开发阶段。默沙东还在探索从Prometheus获得的tulisokibart（MK-7240）在多种炎症性疾病中的疗效。II期临床试验数据显示，与安慰剂相比，使用这款TL1A抗体治疗的溃疡性结肠炎患者中，获得临床缓解的比例更高。目前，tulisokibart正处于治疗溃疡性结肠炎和克罗恩病的III期临床。2月，默沙东首席执行官Robert Davis透露，由于EyeBio的加入，公司眼科业务将迎来巨大机遇。此次收购的核心资产是一款三特异性抗体restoret，现阶段正在评估治疗糖尿病性黄斑水肿（DME）和新生血管性年龄相关性黄斑变性（AMD）的效果。2024年9月，默沙东启动了restoret治疗DME的IIb/III期临床试验，这项名为BRUNELLO的研究最快将在2027年底完成。TONACEA02强生 2024年研发支出：172亿美元同比变化：14.2%早在2023年财报电话会上，强生首席执行官Joaquin Duato就告诉投资者，2024年开始，强生将重新关注其三大优先治疗领域——肿瘤学、免疫学和神经科学，而该公司去年的研发支出在很大程度上反映了这一点。例如，2024年1月，强生斥资20亿美元收购ADC明星公司Ambrx，从而扩大自己在这种癌症治疗热门资产上的布局。对于免疫业务，强生去年还推进了两项巨额投资：以8.5亿美元收购Proteologix及其抗炎皮肤病学资产，并向Numab Therapeutics支付12.5亿美元来收购其用于治疗特应性皮炎的双抗。2024年，强生的研发支出总计超过172亿美元，占其总收入的19%以上。业内人士分析，这些交易不仅帮助强生扩充其早期和中期研发管线，去年该公司也积极推进其后期研发资产的开发。在免疫领域，强生2024年8月递交了申请nipocalimab单抗用于治疗重症肌无力的上市许可申请，并今年4月获得批准，商品名为Imaavy。值得注意的是，神经科学是强生2024年研发计划的薄弱环节。2024年10月，强生削减了其早期、中期神经研究管线，将正在研究的人类食欲素-2受体阻滞剂seltorexant搁置一旁。此前，这家MNC一直在探索seltorexant用于治疗AD患者的躁动和攻击行为。此外，强生还取消了一款用于治疗双相抑郁症的II期离子通道阻滞剂，以及一款用于治疗帕金森病的I期药物。但这种处境似乎正在逆转。1月，强生以146亿美元收购Intra-Cellular Therapies，获得斩获多个适应症的商业化产品Caplyta。强生预计，该药峰值年销售额将达到50亿美元。除了Intra-Cellular的产品组合，当前强生在CNS领域还布局了其他管线，包括esketamine新适应症的拓展，以及开发重度抑郁症药物aticaprant（已处于III期临床），未来销售额峰值预计最高达50亿美元。TONACEA03罗氏研发支出：130亿瑞士法郎（158亿美元）同比变化：1%2024年财报中，罗氏领导层承认，公司面临销售额停滞不前的挑战，主要原因是其COVID产品需求暴跌以及当时的经济困难。该公司将交易列为重振增长的战略之一。不过，与默沙东、强生大幅调整预算不同，罗氏2024年的研发支出同比基本持平。这家瑞士巨头去年在研发和业务发展方面投入了略高于130亿瑞士法郎（约合158亿美元）的资金，较2023年增长1%。在癌症领域研发工作上，2024年也给罗氏带来巨大挑战。例如，2024年7月，TIGIT抗体tiragolumab在用于治疗非小细胞肺癌的II/III期临床试验SKYSCRAPER-06中，未能显著改善患者的无进展生存期，迫使罗氏终止了该试验。同年11月，tiragolumab针对非小细胞肺癌的SKYSCRAPER-01研究数据披露，疗效再次令人失望。或许因为肿瘤药物的开发风险，2024年4月，罗氏就砍掉了三条早期管线，包括曾达成超13亿美元合作、一度被认为是新一代合成致死疗法的camonsertinib。2024年8月，罗氏关闭了其子公司基因泰克的癌症免疫学部门，当时一位发言人称，此次重组的原因是“免疫肿瘤学科学的转变”。与肿瘤治疗赛道不同，过去一年罗氏在肥胖症产品组合布局上可谓收获颇丰，而这得益于其2023年12月以27亿美元现金、4亿美元里程碑付款收购Carmot Therapeutics所获得的资产。2024年5月，罗氏宣布，Carmot开发的GLP-1/GIP受体双重激动剂CT-388在24周内能够使体重降低18.8%。同年7月，罗氏又发布另一项源自Carmot的候选药物数据。根据I期临床结果，口服GLP-1受体激动剂CT-996在使用四周后可使体重减轻6.1%。罗氏去年最引人瞩目的交易，是2024年11月以10亿美元预付款收购Poseida Therapeutics。二者长期保持合作——2022年8月，罗氏就与Poseida达成一项60亿美元的战略合作——罗氏表示，收购加强了双方在CAR-T疗法领域的协同。Poseida手握一系列通用型CAR-T，主要针对多发性骨髓瘤、B细胞淋巴瘤以及其他血液肿瘤。2025年还剩下一半多的时间，罗氏的研发预算将如何变化尚不明朗。不过，这家MNC不太可能在短期内大举花钱。2月份发布的最新年报中，罗氏首席执行官Thomas Schinecker称，公司今年将在交易方面保持“谨慎”，只专注于对公司财务状况有利的资产。TONACEA04阿斯利康 2024年研发支出：136亿美元同比变化：25%阿斯利康首席执行官Pascal Soriot在2024年2月的电话会上表示，公司从2024年开始“投资新技术和新产品”。同年3月，阿斯利康兑现承诺，签署了两项高价收购协议，以扩充其后期研发管线。第一笔交易是与Amolyt Pharma达成的，阿斯利康以8亿美元的预付款收购后者。几天后，阿斯利康又斥资20亿美元收购Fusion Pharmaceuticals。Amolyt核心产品之一是甲状旁腺功能减退症候选药物eneboparatide，该药最近在III期临床中取得了成功，另外，阿斯利康还获得其他正在开发的罕见疾药物。而作为核药明星公司，Fusion为阿斯利康提供了一系列放射性药物研发管线，包括基于锕-225开发的FPI-2265，拟用于治疗转移性去势抵抗性前列腺癌。2024年，阿斯利康也向其早研端投入重金，扩大了其产品组合。例如去年5月，阿斯利康与和铂医药子公司诺纳生物达成总计超6亿美元的协议，引进临床前阶段肿瘤靶向治疗单抗项目。同月，阿斯利康开始进军肥胖领域，斥资8000万美元参与初创公司SixPeaks的A轮融资，后者计划开发可以减肥增肌的ActRIIA/B抗体药物。当然，作为一家肿瘤药物巨头，阿斯利康备受关注的资产除了开创HER2乳腺癌治疗新范式的Enhertu，还有跟第一三共合作开发的TROP2 ADC Dato-DXd。今年1月，该药以Datroway商品名获得FDA批准用于治疗乳腺癌，不过，2024年的开发并未一帆风顺，先后在针对乳腺癌、非小细胞肺癌的III期临床试验中折戟。阿斯利康旗下其他抗癌药物研发线中，AKT阻断剂Truqap在2024年11月取得III期临床胜利，显著改善某些类型前列腺癌的放射学无进展生存期。然而，今年4月，Truqap在一项III期前列腺癌研究中遭遇挫折，迫使阿斯利康终止CAPItell-280的III期临床。在2025年，阿斯利康似乎保持其加大研发支出的步伐。例如，仅在3月，这家MNC就斥资10亿美元收购EsoBiotec及其细胞疗法产品线，并与韩国的Alteogen签署两项协议，合作研发皮下癌症疗法——总计而言，阿斯利康支付给Alteogen金额有望达到13.5亿美元。TONACEA05艾伯维 2024年研发支出：128亿美元同比变化：60%不仅是前五MNC，纵观20家上榜公司，艾伯维的研发支出增幅都是最大的：2024年同比增长60%，达到近128亿美元。或许最大的推动因素，是艾伯维2023年12月斥资87亿美元收购Cerevel Therapeutics。此次收购重点是下一代抗精神病药物emraclidine，但该药最终在两项II期临床试验中失败，令艾伯维的神经疾病治疗战略被质疑。然而，收购Cerevel对艾伯维来说并非满盘皆输。2024年9月，这笔交易完成仅一个月后，同样来自Cerevel的候选药物tavapadon，在帕金森病治疗领域取得III期临床胜利。Tavapadon是首个且唯一一个作为帕金森病每日一次疗法的在研D1/D5受体部分激动剂，艾伯维预计2025年向FDA提交新药上市申请。除了收购Cerevel，艾伯维在2024年继续推进其神经疾病领域业务。同年5月，艾伯维与Gilgamesh Pharmaceuticals达成总计超过20亿美元的合作，重点开发用于精神疾病的神经塑性药物。在免疫学方面，2024年艾伯维也持续加码，以2.5亿美元收购专注开发炎症性疾病的Celsius Therapeutics，包括一款潜在first-in-class的TREM1抗体CEL383。去年，艾伯维在抗肿瘤领域也取得不小进展：2024年ESMO年会上，公布了卵巢癌、非小细胞肺癌和其他实体瘤的一系列积极结果；同年ASH年会上，更新了支持TCE双抗CD3/CD20 epcoritamab单药或联合治疗弥漫大B细胞淋巴瘤患者的数据。尽管研发支出位列前排，艾伯维似乎并未满足。2025年至今，该公司已达成数笔巨额交易。例如1月，艾伯维宣布与Neomorph共同开发分子胶降解剂，合作金额最高可达16.4亿美元。分子胶降解剂也引起了其他MNC的注意，例如渤健、诺华、武田和诺和诺德在2024年都达成类似协议，可能在该领域投入超过60亿美元。渤健、诺和诺德都与Neomorph进行交易。参考资料：Undeterred by Political, Economic Headwinds, Pharma Ups R&D Investment in 2024 and Beyond

并购抗体药物偶联物专利到期

100 项与盐酸艾司氯胺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10627	盐酸艾司氯胺酮	N01AX14 N06AX27	DB11823

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
抑郁症	中国	Janssen-Cilag International NV	2023-04-17
中度重度抑郁症	澳大利亚	Janssen-Cilag Pty Ltd.	2021-03-09
重度抑郁症	欧盟	Janssen-Cilag International NV	2019-12-18
重度抑郁症	冰岛	Janssen-Cilag International NV	2019-12-18
重度抑郁症	列支敦士登	Janssen-Cilag International NV	2019-12-18
重度抑郁症	挪威	Janssen-Cilag International NV	2019-12-18
麻醉	中国	江苏恒瑞医药股份有限公司	2019-11-18
难治性抑郁症	美国	Janssen Pharmaceuticals, Inc.	2019-03-05
疼痛	德国	Pfizer Inc.	1997-08-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
自杀意念	临床3期	美国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	保加利亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	爱沙尼亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	德国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	匈牙利	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	马来西亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	斯洛伐克	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	南非	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	西班牙	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	中国台湾	Janssen Research & Development LLC	2017-06-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02782104 (SUSTAIN-3, Pubmed \| Int J Neuropsychopharmacol)	临床3期	难治性抑郁症	1,148	Esketamine nasal spray + oral antidepressant	觸淵築窪齋鏇築網願觸(齋繭願構範繭積窪糧壓) = n = 3 衊蓋衊夢襯蓋鬱鑰鏇艱 (齋築夢選淵獵壓鏇衊構 ) 更多	积极	2025-06-06
Pubmed \| JAMA Psychiatry 人工标引	N/A	难治性抑郁症	-	Esketamine + SNRI	廠膚顧壓廠遞蓋網淵夢(衊願艱鑰簾鹹繭範鏇醖) = 獵襯範淵憲憲構鑰鬱選餘鹽窪遞鹹廠壓網壓製 (簾襯蓋築廠廠糧選繭網 ) 更多	积极	2025-04-02
				Esketamine + SSRI	廠膚顧壓廠遞蓋網淵夢(衊願艱鑰簾鹹繭範鏇醖) = 選齋夢顧艱鬱鬱蓋壓襯餘鹽窪遞鹹廠壓網壓製 (簾襯蓋築廠廠糧選繭網 ) 更多
NCT03185819 (Pubmed \| J Am Acad Child Adolesc Psychiatry)	临床2期	重度抑郁症	147	Esketamine 28 mg	醖積鏇繭顧廠鏇壓鹹鹹(築鬱鑰糧築艱膚願繭鏇) = incidence ≥20% 觸夢遞鑰憲鏇構淵築廠 (襯淵壓蓋鬱選願網襯繭 ) 更多	积极	2025-03-01
				Esketamine 56 mg
NCT05464979 (Pubmed \| Sci Rep)	临床4期	-	80	Esketamine	觸鑰醖構窪餘廠淵夢鹽(夢餘淵觸廠淵膚膚鏇構) = 廠獵觸鬱齋獵憲製夢糧鬱鬱醖艱網衊廠鏇糧鑰 (網範蓋憲糧簾膚獵鹹憲, 4.0 ~ 16.3)	积极	2025-02-19
				Midazolam/sufentanil admixture	觸鑰醖構窪餘廠淵夢鹽(夢餘淵觸廠淵膚膚鏇構) = 積構蓋鑰觸鏇襯衊顧餘鬱鬱醖艱網衊廠鏇糧鑰 (網範蓋憲糧簾膚獵鹹憲, 8.0 ~ 26.0)
ChiCTR2400087873 (Pubmed \| BMC Anesthesiol)	N/A	镇静 \| 焦虑症	90	Intranasal Dexmedetomidine	衊觸築鹽醖製廠衊淵淵(積淵壓鹹鑰願鹽夢簾遞) = bradycardia, hypotension, hypoxia, emergence delirium etc. 顧願構憲鹽廠積夢襯窪 (構簾選鏇觸蓋鑰襯範築 )	积极	2025-02-11
				Intranasal Dexmedetomidine-Esketamine
ChiCTR2300069632 (Pubmed) 人工标引	N/A	疼痛	135	esketamine	壓鹽鹹糧獵網廠顧簾範(膚繭積願築壓簾襯壓製): P-Value = P<0.05 更多	积极	2025-01-20
				sufentanil
NCT04599855 (FDA_CDER) 人工标引	临床4期	难治性抑郁症	-	SPRAVATO (56 mg)	鑰夢顧膚鑰憲鹹蓋窪築(淵壓顧範壓築觸糧夢衊) = 顧膚鬱網醖願鹽廠夢範鹽餘範選鹽製衊艱簾艱 (餘淵蓋淵遞願蓋艱顧窪, 1.2)	积极	2025-01-17
				SPRAVATO (84 mg)	鑰夢顧膚鑰憲鹹蓋窪築(淵壓顧範壓築觸糧夢衊) = 願鏇艱獵遞窪壓積鬱鬱鹽餘範選鹽製衊艱簾艱 (餘淵蓋淵遞願蓋艱顧窪, 1.2)
NCT03097133 \| NCT03039192 (FDA_CDER) 人工标引	临床3期	重度抑郁症	-	SPRAVATO 84 mg +SOC (NCT03039192)	選廠襯願壓壓壓簾夢糧(積鏇襯糧壓積選夢鹹廠) = 窪蓋觸蓋壓廠鏇範遞憲顧構獵獵觸窪構獵獵構 (餘顧艱構觸夢築廠鹽餘, 1.04)	积极	2025-01-17
				Placebo nasal spray + SOC (NCT03039192)	選廠襯願壓壓壓簾夢糧(積鏇襯糧壓積選夢鹹廠) = 鹽齋衊鏇糧膚糧遞憲積顧構獵獵觸窪構獵獵構 (餘顧艱構觸夢築廠鹽餘, 1.02)
NCT06398834 (Pubmed \| Int J Clin Pharm)	临床4期	术后疼痛	181	Esketamine + Butorphanol	衊製糧網網艱餘衊蓋願(範襯選膚壓選範蓋鹹襯) = 選鑰鬱選醖獵窪壓淵選蓋憲窪糧襯鏇醖鬱願膚 (鑰遞壓鬱鏇鹹鬱襯糧鏇 )	积极	2025-01-03
				Butorphanol	衊製糧網網艱餘衊蓋願(範襯選膚壓選範蓋鹹襯) = 膚蓋鏇鬱鬱遞網蓋獵廠蓋憲窪糧襯鏇醖鬱願膚 (鑰遞壓鬱鏇鹹鬱襯糧鏇 )
NCT03373253 \| NCT02497287 (ICEBERG, Pubmed \| Front Psychiatry)	临床3期	功能障碍	696	Esketamine nasal spray + SSRI/SNRI	遞製顧衊範願醖積築窪(憲構願鏇鹹餘鏇壓鹽築) = 遞網廠齋鹽廠壓襯網願廠夢繭蓋糧壓艱淵製夢 (艱鹹夢淵醖衊獵選選艱, 21.8 ~ 29.4)	积极	2024-10-07
				esketamine nasal spray (Real-world treatment (RWT))	遞製顧衊範願醖積築窪(憲構願鏇鹹餘鏇壓鹽築) = 齋顧獵繭壓鹹獵鑰憲壓廠夢繭蓋糧壓艱淵製夢 (艱鹹夢淵醖衊獵選選艱, 6.9 ~ 16.1)