The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

开始日期2025-06-01

申办/合作机构

Montefiore Medical Center

NCT06382012 / Recruiting临床2/3期IIT

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.

开始日期2024-11-13

申办/合作机构

Montefiore Medical Center

ChiCTR2400088071 / Suspended临床4期IIT

The Effect of Fosaprepitant on Postoperative Delirium and Sleep Quality in Elderly Gynecological Laparoscopic Surgery Patients: A Prospective Randomized Controlled Study

开始日期2024-08-10

申办/合作机构-

100 项与福沙匹坦双葡甲胺相关的临床结果

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100 项与福沙匹坦双葡甲胺相关的转化医学

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100 项与福沙匹坦双葡甲胺相关的专利（医药）

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246

项与福沙匹坦双葡甲胺相关的文献（医药）

2025-01-01·ANESTHESIA AND ANALGESIA

Anesthesia Providers’ Knowledge of Medication Interference with Hormonal Contraception: A Multisite Survey

Article

作者: Whitney, Madeline ; Buckner-Petty, Skye ; Kraus, Molly B. ; Harbell, Monica W. ; Sharpe, Emily E.

BACKGROUND::

Sugammadex, aprepitant, and fosaprepitant are increasingly used perioperatively. These medications may interfere with the effectiveness of hormonal contraception. This study assessed anesthesia providers’ use of sugammadex and aprepitant, their knowledge of interactions with hormonal birth control, and patient counseling practices to identify possible knowledge gaps or opportunities for practice improvement.

METHODS::

In January 2023, an electronic survey was distributed to all anesthesia providers at Mayo Clinic sites (Mayo Clinic Rochester, Mayo Clinic Arizona, Mayo Clinic Florida, and Mayo Clinic Health System hospitals). The survey included 32 questions assessing providers’ use of sugammadex and aprepitant, their knowledge of the medications’ interactions with hormonal contraceptives (HC), their perceptions regarding education of these interactions during training, and their perioperative patient counseling practices. The collected data were analyzed using descriptive statistics.

RESULTS::

A total of 337 of 1092 (31%) providers completed the survey. While almost all respondents (324; 96%) knew that sugammadex may interfere with oral contraceptive effectiveness, only 158 (47%) knew about aprepitant’s potential contraceptive interference. Only 176 providers (52%) knew the recommended duration for alternative contraceptive methods after use after sugammadex, and 119 providers (35%) knew the recommended duration after aprepitant exposure. Most respondents considered the interference of these perioperative drugs with HCs to be clinically relevant (sugammadex, 217, 64%; aprepitant, 191, 58%). Despite the common belief that the decision between these medications and alternatives should be shared between provider and patient, most providers reported rarely engaging in such shared decision-making (SDM) in practice. Most providers recognized the need for preoperative discussions on sugammadex (280, 83%) and aprepitant (257, 76%), yet 184 providers (73%) never or rarely discussed contraception use before surgery for aprepitant, and 135 (36%) never or rarely did so for sugammadex. Lastly, many providers believed that the interference between sugammadex, aprepitant, and HC was poorly taught during training.

CONCLUSIONS::

The results of this study highlight the need for increased education and awareness among anesthesia providers regarding drug interactions with HCs during the perioperative period. To facilitate SDM, it is imperative that providers discuss alternative medications and the potential need for additional contraception methods after drug administration and communicate the risks with patients preoperatively to enable informed and SDM. The patient’s preferences should be accounted for, especially if they are unwilling or unable to use an alternative contraceptive for 7 to 30 days, thereby avoiding the complexities and burdens of altering birth control methods.

2024-12-01·SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES

Incidence of post-operative nausea and vomiting after endoscopic bariatric and metabolic therapy procedures and the role of neurokinin-1 receptor antagonists: a retrospective cohort study

Article

作者: VanderWielen, Beth A ; Weingarten, Toby N ; VanderWielen, Beth A. ; Schroeder, Darrel R. ; Weingarten, Toby N. ; Schroeder, Darrel R ; Sprung, Juraj ; Storm, Andrew C. ; Storm, Andrew C

BACKGROUND:

Both the transoral gastric reduction (TORe) and endoscopic sleeve gastroplasty (ESG) procedures are novel endoscopic bariatric and metabolic therapies (EBMT). Our practice has an aggressive approach to prophylaxis of postoperative nausea and vomiting (PONV) for EBMT cases, but there is divergence of practice regarding use of prophylactic neurokinin-1 receptor (NK-1) antagonists (aprepitant, fosaprepitant). Herein, we determined the incidence of PONV and its potential association with NK-1 antagonist administration following EBMT.

METHODS:

We identified and reviewed medical records of patients who underwent EBMT between 2018 and 2023. Patients were divided into those administered or not administered an NK-1 antagonist. We analyzed rates of PONV, which was defined as rescue antiemetics during anesthesia recovery. A propensity score was calculated, and outcomes were assessed using generalized estimating equations with inverse probability of treatment weighting (IPTW).

RESULTS:

We identified 404 patients undergoing EBMT (256 [63%] TORe, 148 [37%] ESG), and of these 253 patients developed PONV, (62.6% [95% CI: 57.9% to 67.3%]). NK-1 antagonists were administered to 119 (29.5%) patients. PONV was experienced by 42 (35%) and 211 (74%) of patients who were or were not administered an NK-1 antagonist, respectively (IPTW OR = 0.18, [95%CI: 0.10 to 0.31], P < 0.001).

CONCLUSIONS:

EBMT has a high incidence of PONV during anesthesia recovery. Administration of a NK-1 antagonist as part of a multiagent PONV prophylaxis regimen dramatically reduces risk for this common adverse event.

2024-11-01·JOURNAL OF PHARMACOLOGICAL SCIENCES

Effect of antiemetics on zolbetuximab-induced gastric injury and emesis in ferrets

Article

作者: Nagata, Masanori ; Nakazawa, Taisuke ; Ugawa, Tohru ; Yamanaka, Yosuke ; Kinugasa, Fumitaka ; Kajikawa, Satoru ; Akuzawa, Shinobu ; Haggerty, Gillian ; Weng, Jane ; Fushiki, Hiroshi ; Sawamoto, Taiji ; Suzuki, Hiroshi

Claudin-18 splice variant 2 (CLDN18.2), a tight junction protein, is a highly cell type-specific antigen that is expressed by differentiated gastric mucosa cells. The expression of CLDN18.2 in gastric mucosa cells may be retained upon malignant transformation and is displayed on the surface of several tumors, including gastric/gastroesophageal junction adenocarcinoma. Zolbetuximab is a genetically engineered, highly purified chimeric (mouse/human IgG1) antibody directed against CLDN18.2. Nausea and vomiting were observed as adverse events of zolbetuximab. To investigate the mechanism of nausea and vomiting in humans, we evaluated emesis (retching and vomiting) and conducted histopathologic assessment in ferrets after the administration of zolbetuximab. Emesis was frequently observed in all ferrets treated with zolbetuximab in the first hour after administration. Histopathologic assessment revealed the surface of the gastric mucosa was the primary site of emesis-associated tissue damage. The effect of antiemetics (dexamethasone, ondansetron, fosaprepitant, and olanzapine) on emesis induced by zolbetuximab was investigated. Fosaprepitant showed suppressive effects on emesis, and use of dexamethasone or concomitant use of fosaprepitant with other antiemetics tended to alleviate gastric tissue damage. The onset of emesis in humans receiving zolbetuximab may be associated with damage in the gastric mucosa, and antiemetics may mitigate gastrointestinal adverse events.

114

项与福沙匹坦双葡甲胺相关的新闻（医药）

2024-12-16

·ioncology

2024中华医学会肿瘤学大会癌痛全程管理精彩内容回顾

2024年12月13日—15日，2024中华医学会肿瘤学大会支持与康复治疗分会场在沈阳皇朝万鑫酒店6号会议厅成功召开。中华医学会肿瘤分会委员兼支持与康复治疗学组组长沈赞教授、中国医科大学附属第一医院刘云鹏教授、中国医科大学附属第一医院曲秀娟教授担任分会场的大会主席，上海交通大学医学院附属仁济医院王理伟教授、中国医科大学附属盛京医院王玉梅教授、中国医科大学附属盛京医院张晓晔教授担任大会主持。会议内容吸引了大批有志于肿瘤支持与康复治疗的专家和医生参会，同时邀请多位肿瘤领域知名专家带来癌痛患者全程管理新进展、安宁疗护同情默应、肿瘤患者全程康复管理实践与研究、中医在肿瘤患者康复中的应用、睡眠与肿瘤患者的康复等肿瘤支持与康复治疗相关最前沿研究报告，多位学术大咖共聚一堂各抒己见，内容丰富，精彩纷呈。大会致辞刘云鹏教授中国医科大学附属第一医院专家授课《癌痛患者全程管理新进展》沈赞教授上海市第六人民医院会议现场癌痛药物治疗策略亟待提升，氢吗啡酮填补临床空白沈赞教授作了《癌痛患者全程管理新进展》的专题学术报告，就当前癌痛治疗现状和NCCN指南在癌痛治疗中新的修改内容做了详细介绍，同时针对癌痛全程管理领域中滴定、维持治疗、阿片类药物不良反应防治等领域中涌现出的新药品如盐酸氢吗啡酮缓释片（商品名称：锐宁®）、注射用福沙匹坦双葡甲胺（商品名称：安福希®）等从临床研究、临床营养和药物未来前景等方面做了细致阐述。阿片类药物为癌痛全程管理的基础用药，传统的治疗药物以吗啡、羟考酮口服即释、缓释制剂以及芬太尼透皮贴为主，近年来国内涌现新剂型及新品种较少，氢吗啡酮为其中突出代表。氢吗啡酮是一种半合成的阿片类镇痛药，主要作用于μ阿片受体，其口服效力约为吗啡的5倍，胃肠外途径给药时其镇痛药效约是吗啡的8-10倍，起效快，主要代谢产物无活性，不良反应少，是众多指南共识推荐的中重度癌痛治疗一线用药。目前，该活性成分国内有注射液、缓释片两种制剂获批上市，氢吗啡酮的上市正在填补国内空白，为临床使用带来更多便利性，为癌痛患者带来新曙光！盐酸氢吗啡酮缓释片作为宜昌人福药业独家上市的药品，是国内首个24小时长效口服阿片类缓释制剂，相较于临床常用的吗啡和羟考酮的口服缓释制剂更加贴合NCCN指南癌痛管理的5A目标。它采用独特的口服渗透泵缓释技术（Osmotic Release Oral System，OROS），可提供24小时持久镇痛，一天仅需口服一次，患者依从性更高，且释药呈零级动力学，不受介质环境影响，患者血药浓度更加平稳，因为释药口细小和悬液的黏度高，很难用针头或口吸的方法达到滥用的目的，具有防滥用的特性。且国谈医保定价比现有的同类药物价格更低，能进一步降低患者的经济负担，提升药物的临床可及性！本次大会为临床医生带来了肿瘤支持与康复治疗最前沿的学术资讯，同时也为癌痛全程管理提供了更多专业、规范的治疗建议，其宗旨是促进国内肿瘤支持与康复治疗领域的学术交流和技术进步，提升我国肿瘤支持与康复治疗的管理水平，为癌痛患者带来更多希望！（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

上市批准

2024-12-13

·米内网

【重磅】$15亿大品种，豪森、朱养心斩获首仿

精彩内容 12月12日，NMPA官网显示，豪森药业、杭州朱养心药业以仿制4类报产的司来帕格片同日获批上市，并列国内首仿+首家过评。司来帕格片为肺动脉高压药，原研药2023年全球销售额超15亿美元。司来帕格片是一种口服有效、高选择性和长效的非前列腺素类前列环素受体（IP受体）激动剂，可改善损伤的肺动脉内皮依赖性舒张，并可能抑制人肺平滑肌细胞的增殖、肺血管壁的增厚，用于治疗肺动脉高压（PAH，WHO第1组）以延缓疾病进展及降低因PAH而住院的风险。米内网数据显示，强生的司来帕格片自上市以来，销售额一路飙升，2023年全球销售额超过15亿元，同比增长19.7%；2023年中国三大终端六大市场（统计范围详见本文末）司来帕格片销售额超过2亿元，同比增长24.61%。强生司来帕格片全球销售情况（百万美元）来源：米内网跨国上市公司销售库目前，国内已有4家企业豪森药业、杭州朱养心药业、湖南方盛制药、重庆圣华曦药业提交司来帕格片的仿制4类上市申请。其中，豪森药业、杭州朱养心药业该产品均于12月10日获批上市，并列国内首仿+首家过评。截至目前，豪森药业已有14个首仿品种在国内获批上市，包括恩扎卢胺软胶囊、酒石酸伐尼克兰片、恩格列净片、帕利哌酮缓释片、马来酸阿法替尼片、卡格列净片、注射用福沙匹坦双葡甲胺、地拉罗司片、醋酸艾替班特注射液等。资料来源：米内网数据库、NMPA注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价

2024-12-12

·药智网

这条赛道，仅恒瑞拥有1款活跃新药

抗肿瘤药物治疗，包括细胞毒药物化疗（以下简称化疗）、靶向治疗和免疫治疗等，可引起多种不良反应，最为常见的就是恶心和呕吐。用于预防或减少抗肿瘤药物所致恶心呕吐的治疗方法，成为恶性肿瘤患者支持疗法中的必要组成部分。目前，全球处于在研阶段的放化疗止吐药物以改良型新药为主，处于活跃状态的创新药仅恒瑞医药的HR-20013。注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 01 放化疗止吐药研发动态目前，全球处于在研阶段的放化疗止吐药物以改良型新药为主，处于活跃状态的创新药仅HR-20013。 HR-20013：由恒瑞医药自主研发的HRS5580和帕洛诺司琼的复方制剂。其中HRS5580是创新分子，通过拮抗NK-1受体发挥止吐作用，半衰期长，具有高度的中枢神经系统渗透性，单药注射剂开发用于预防术后恶心和呕吐已获批临床。帕洛诺司琼是已上市使用的选择性5-HT3拮抗剂。HR-20013同时作用于5-HT3和NK-1受体，双途径抑制呕吐反射。其Ⅲ期临床试验结果显示，用于预防高致吐性化疗引起的恶心呕吐时，联合地塞米松具有可靠的疗效，且疗效在后续周期也有很好地保持。改良型新药聚焦于新复方制剂和新剂型的研发，例如BH006和LP-035。 BH006：贝海生物自主开发的全球首款福沙匹坦和帕洛诺司琼的固定复方制剂，同样作用于5-HT3和NK-1受体。相比传统的三药联用止吐方案，BH006每个疗程仅需注射给药1次，可减少给药次数，简化用药程序，从而提高患者依从性。 LP-035：力品药业（厦门）股份有限公司研发的盐酸帕洛诺司琼口颊膜，为中美首款进入临床阶段的口颊膜新型制剂。该制剂具有使用方便、依从性好等优点，有望为放化疗患者提供更便捷的治疗选择。 02 放化疗止吐药市场现状 2023年，中国放化疗止吐药市场销售额达47.76亿元，2019年-2023年5年复合增长率为-7.82%。目前总计有2个放化疗止吐药纳入国家集中采购，多个药物纳入省级集采，受价格大幅下降影响，市场销售额处于下降趋势，2023年销售额同比2022年下降8.37%。图1 中国放化疗止吐药总体市场规模及增速数据来源：药智数据，药智咨询整理目前，中国放化疗止吐药市场以5-羟色胺3受体拮抗剂（5-HT3 RA）为主导，该类药物产品多且临床疗效好，是多种放化疗止吐方案的首选药物。2023年，市场份额最大的是昂丹司琼，占比23.37%，其次是托烷司琼（占比20.48%）和帕洛诺司琼（占比8.13%）。尽管帕洛诺司琼因纳入国家集采而销售额大幅下降，但其作为新一代5-HT3 RA，在预防延迟性恶心呕吐方面显著优于第一代药物，因此预计市场需求依然会增长。 NK-1受体拮抗剂（NK-1 RA）的销售额和市场份额近年来呈增长趋势，以阿瑞匹坦和福沙匹坦为代表。这类药物通过竞争性抑制NK-1受体与P物质结合，有效预防延迟性恶心呕吐。随着临床应用的不断深入和新型复方制剂的研发上市，NK-1 RA的市场前景广阔。此外，糖皮质激素（如地塞米松）、非典型抗精神病药物（如奥氮平）和其他药物（如甲氧氯普胺）也在放化疗止吐药市场中占据一定份额。然而，这些药物通常作为辅助治疗或二线治疗使用，市场份额相对较小。 03 ANIV的分类及疾病特点抗肿瘤治疗所致恶心呕吐（AINV）根据抗肿瘤治疗方式，可分为化疗所致恶心呕吐（CINV）、靶向治疗及免疫治疗所致恶心呕吐（TIINV）和放疗所致恶心呕吐（RINV）。CINV和TIINV根据发生时间和治疗效果分为急性、延迟性、预期性、暴发性和难治性5类。化疗和靶向治疗及免疫治疗所致恶心呕吐的特点相似，急性恶心呕吐通常在化疗后24小时内发生，5-6小时达到高峰；延迟性恶心呕吐则发生在化疗24小时之后，48-72小时达到高峰，可持续6-7天。预期性恶心呕吐、暴发性恶心呕吐和难治性恶心呕吐则更多与患者的心理预期、治疗效果和既往病史相关。放疗所致恶心呕吐则可能在治疗后24小时内（急性期）或治疗结束后2-10天（延迟期）发生。 AINV的发生机制目前虽尚未完全明确，但已发现一些关键因素。化疗和靶向治疗及免疫治疗所致恶心呕吐的发生机制主要涉及外周途径和中枢途径，而放疗所致恶心呕吐则是多因素共同作用的结果。 04 疾病诊疗方案及治疗药物《中国肿瘤药物治疗相关恶心呕吐防治专家共识（2022年版）》提出，由于化疗所致恶心呕吐（CINV）最为严重、研究最为深入、疗效最为确切，其他抗肿瘤药物所致的恶心呕吐均参照CINV的原则处理。预防性止吐治疗是控制AINV的主要手段。预防性止吐方案基于抗肿瘤药物的致吐风险等级。根据未进行任何预防性处理时，单独使用某一抗肿瘤药物发生急性恶心呕吐的概率，致吐风险分为高度、中度、低度和轻微4个等级：表1 常用化疗药物致吐风险等级资料来源：《化疗所致恶心呕吐中西医诊治专家共识》，药智咨询整理注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。医师应根据既往使用止吐药物的经验和化疗方案的致吐风险分级选择不同类型的止吐药物，同时应对患者是否合并其他危险因素进行评估。联合应用抗肿瘤药物时，应基于致吐风险最高的药物来选择止吐药物。每个治疗周期前均应进行恶心呕吐风险的评估，根据风险评分情况及时调整治疗方案。专家共识推荐使用Dranitsaris评分系统个体化预测患者恶心呕吐的发生风险。抗肿瘤治疗所致恶心呕吐的治疗药物主要包括5-HT3受体拮抗剂、NK-1受体拮抗剂、糖皮质激素、非典型抗精神病药物等。根据患者恶心呕吐风险的评估结果，轻微和低风险患者使用单一止吐药物或不用，中风险患者使用二联止吐方案，高危患者使用三联甚至四联止吐方案。表2 AINV治疗药物分类及指南推荐情况资料来源：《中国肿瘤药物治疗相关恶心呕吐防治专家共识》，药智咨询整理注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 05 结语尽管AINV的治疗药物众多，但临床未满足需求依然显著。尤其是TIINV和RINV等CINV以外的AINV种类，目前研究尚不充分，缺乏针对性的临床指南和专家共识。此外，国内外AINV临床实践对现有指南和准则的遵循情况也不尽如人意。化疗药持续时间与止吐药持续时间的不对等，更是给患者带来了诸多不便和副作用的风险。未来，随着新型药物的研发上市和临床应用的不断深入，我们有理由相信，AINV的治疗将更加精准、有效和便捷。同时，我们也期待更多的临床指南和专家共识能够出台，为AINV的规范化治疗提供有力支持。参考来源： [1]肖彩芝,王维,夏冬琴,等.化疗所致恶心呕吐中西医诊治专家共识[J].中国医院用药评价与分析,2023,23(12):1409-1415,1421. [2]张玉.化疗所致恶心呕吐的药物防治指南[J].中国医院药学杂志,2022,42(05):457-473. [3]Patel P,Robinson PD,Cohen M,et al.Prevention of acute and delayed chemotherapy-induced nausea and vomiting in pediatric cancer patients:A clinical practice guideline.Pediatr Blood Cancer.2022 Dec;69(12):e30001. [4]肿瘤药物治疗相关恶心呕吐防治中国专家共识（2019年版）[J].中国医学前沿杂志（电子版）,2019,11(11):16-26. [5]肿瘤治疗相关呕吐防治指南（2014版）[J].临床肿瘤学杂志,2014(3):263-273. [6]基于真实世界处方数据的化疗引起的恶心呕吐预防实践模式和止吐指南依从性-Aapro-2021-肿瘤学家-Wiley Online Library 声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）如需定制医药咨询服务，请扫描下方二维码咨询！阅读原文，是受欢迎的文章哦

临床3期免疫疗法上市批准申请上市

100 项与福沙匹坦双葡甲胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06597	福沙匹坦双葡甲胺	A04AD12	DB06717

研发状态

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适应症	国家/地区	公司	日期
恶心	中国	江苏豪森药业集团有限公司	2019-09-29
呕吐	中国	江苏豪森药业集团有限公司	2019-09-29
化疗引起的恶心和呕吐	欧盟	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	冰岛	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	列支敦士登	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	挪威	Merck Sharp & Dohme BV	2008-01-11

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适应症	最高研发状态	国家/地区	公司	日期
脑积水，心内膜纤维弹性增生和白内障	临床3期	中国	江苏豪森药业集团有限公司	2015-02-06
恶心和呕吐	临床3期	中国	江苏豪森药业集团有限公司	2015-02-06
术后恶心呕吐	临床3期	-	Merck Sharp & Dohme Corp.	2005-07-01
晚期非小细胞肺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2015-04-01
非小细胞肺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2015-04-01
转移性黑色素瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2013-09-01
转移性肾细胞癌	临床2期	美国	Merck Sharp & Dohme Corp.	2013-09-01
生殖细胞和胚胎肿瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2013-01-01

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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


ASCO2024	N/A	-	-	Fosaprepitant	選網襯糧獵範觸憲獵鹽(鏇憲願簾積積繭衊鹽網) = 廠窪築觸淵糧獵範壓積遞憲窪製鏇範廠衊鬱選 (糧築壓繭艱鹹糧鹽範膚 )	不佳	2024-05-24
NCT03237611 (CTgov)	临床2期	化疗引起的恶心和呕吐	15	Ondansetron 16 MG+Aprepitant 125 mg+Dexamethasone+Fosaprepitant 115 MG	網糧顧夢膚鏇艱鹹膚壓(構糧積襯憲鏇糧衊鑰襯) = 糧齋蓋廠鹹壓築鹽艱餘選鏇蓋範鹹製鹹蓋膚鹽 (齋壓鹹範糧獵夢淵鑰觸, 願蓋夢選艱鏇鑰衊艱鏇 ~ 鑰膚憲繭製鹽獵鏇膚範) 更多	-	2023-11-13
NCT05564286 (Pubmed \| Support Care Cancer)	临床3期	化疗引起的恶心和呕吐	116	Fosaprepitant, tropisetron, and dexamethasone	鬱醖鏇醖顧蓋構艱鏇構(遞鹹鑰憲膚糧窪鬱憲顧) = Fosaprepitant was well tolerated as the incidences of adverse events in the two groups were comparable 淵遞膚製衊壓餘壓鑰醖 (網壓簾蓋夢鏇膚繭餘膚 ) 更多	积极	2023-11-01
				Tropisetron plus dexamethasone
FDA 人工标引	N/A	化疗引起的恶心和呕吐	1,000	FOCINVEZ+ondansetron+dexamethasone (Intravenous)	觸齋蓋網鏇糧蓋鹽憲蓋(鏇齋餘窪壓壓艱構積繭) = 壓鬱簾鏇憲齋簾簾鏇鬱醖鬱膚衊鑰襯鹹糧鑰壓 (襯網齋淵蓋願夢鹽遞觸 ) 更多	积极	2023-08-22
				ondansetron+dexamethasone	觸齋蓋網鏇糧蓋鹽憲蓋(鏇齋餘窪壓壓艱構積繭) = 築夢範鏇簾選選網夢構醖鬱膚衊鑰襯鹹糧鑰壓 (襯網齋淵蓋願夢鹽遞觸 ) 更多
FDA 人工标引	N/A	化疗引起的恶心和呕吐	2,322	FOCINVEZ+ondansetron+dexamethasone (Intravenous)	願糧鏇願醖願鹽蓋構憲(糧鬱繭顧衊廠憲淵醖齋) = 顧築構繭製獵鏇憲範願構繭艱糧願醖遞獵積築 (鬱選鬱衊糧廠壓簾選鹽 ) 更多	积极	2023-08-22
				Aprepitant+ondansetron+dexamethasone (Oral)	願糧鏇願醖願鹽蓋構憲(糧鬱繭顧衊廠憲淵醖齋) = 淵製壓簾壓構願艱糧獵構繭艱糧願醖遞獵積築 (鬱選鬱衊糧廠壓簾選鹽 ) 更多
NCT03578081 (CTgov)	临床3期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 ... 更多	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	餘醖繭鏇鹽蓋顧膚憲鹹(淵製醖淵鑰遞憲衊簾膚) = 壓顧齋繭壓網膚觸膚淵顧襯膚鹹窪構齋艱選遞 (簾艱艱糧構廠獵網範範, 製襯獵餘蓋繭築簾蓋網 ~ 鹹鑰淵襯觸廠蓋襯觸襯) 更多	-	2023-05-08
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	餘醖繭鏇鹽蓋顧膚憲鹹(淵製醖淵鑰遞憲衊簾膚) = 觸淵鬱築廠窪鏇選願蓋顧襯膚鹹窪構齋艱選遞 (簾艱艱糧構廠獵網範範, 窪憲廠網鹹鬱醖壓鹹鹽 ~ 窪觸鹹願顧築膚淵顧鑰) 更多
ACAAI2022	N/A	过敏	-	Fosaprepitant 150mg	鬱網糧廠構膚醖選壓憲(鹹繭廠製夢簾襯衊衊遞) = A tryptase level was drawn 3 hours after symptom onset and was elevated to 13.2 mcg/L (baseline 6.7 mcg/L) 選築艱衊築構壓積壓遞 (鑰顧獵衊構夢簾願壓襯 ) 更多	-	2022-11-10
NCT03197064 (CTgov)	临床4期	术后恶心呕吐	11	Fosaprepitant 150 mg	築遞蓋獵壓構鏇膚製淵(醖遞鑰夢鹹鏇糧網製願) = 範簾膚壓廠顧簾繭鹽衊顧鬱艱憲憲鑰觸觸製醖 (鬱積壓鹽醖構範壓齋憲, 願襯鏇壓願餘憲膚衊壓 ~ 築襯窪鹽壓顧醖鑰觸憲) 更多	-	2022-07-18
NCT04054193 (0517-045 \| MK-0517-045, CTgov)	临床4期	恶心 \| 化疗引起的恶心和呕吐 \| 呕吐	103	5-HT3 antagonist+Dexamethasone+Fosaprepitant Dimeglumine	選簾築餘繭鑰顧顧鹹遞(構鏇顧鏇鏇淵範衊鬱淵) = 淵憲範齋顧夢糧壓選壓選淵廠廠築鹽襯糧積鏇 (製齋憲衊蓋鏇鹹壓齋鑰, 糧窪餘餘選觸遞夢衊醖 ~ 鹹觸網觸構廠鏇構襯簾) 更多	-	2021-09-23
CTRI/2017/02/007925 (ASCO2018)	临床3期	化疗引起的恶心和呕吐	135	Fosaprepitant	鏇構顧遞襯艱鏇鬱襯憲(廠餘壓顧範獵繭衊簾鑰) = 鬱積積齋醖遞壓齋鹽選膚選壓獵壓鹹獵艱顧廠 (餘選繭選觸鹽衊蓋餘衊 ) 更多	积极	2018-06-01
				Placebo	鏇構顧遞襯艱鏇鬱襯憲(廠餘壓顧範獵繭衊簾鑰) = 鹽淵簾範齋艱鏇鹹餘顧膚選壓獵壓鹹獵艱顧廠 (餘選繭選觸鹽衊蓋餘衊 ) 更多