盐酸帕洛诺司琼(Palonosetron hydrochloride) - 药物靶点：5-HT3 receptor_在研适应症：恶心，呕吐，术后恶心呕吐_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one、2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one、Aloxi Injection

+ [18]

靶点

5-HT3 receptor

作用机制

5-HT3 receptor拮抗剂(5-羟色胺受体3拮抗剂)

治疗领域

其他疾病

在研适应症

恶心呕吐术后恶心呕吐+ [1]

非在研适应症

急性髓性白血病胶质瘤淋巴瘤+ [4]

原研机构

Helsinn Healthcare SA

在研机构

Accord Healthcare SLU

齐鲁制药有限公司

Helsinn Birex Pharmaceuticals Ltd.

+ [4]

非在研机构

Helsinn Healthcare SA

兆科药业（合肥）有限公司

Eisai, Inc.

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2003-07-25),

化疗引起的恶心和呕吐

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C19H25ClN2O

InChIKeyOLDRWYVIKMSFFB-SSPJITILSA-N

CAS号135729-62-3

关联

236

项与盐酸帕洛诺司琼相关的临床试验

NCT06540885

/ Not yet recruiting临床4期IIT

A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA).
The main questions the study aims to answer are:
How effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

开始日期2025-01-01

申办/合作机构

University of Malaya

CTRI/2024/09/074272

/ Not yet recruitingN/AIIT

Comparative Study of the Efficacy of Intravenous Ondansetron Versus Intravenous Palonosetron in the Prevention of Postoperative Nausea and Vomiting in Elective Laparoscopic Surgeries - NIL

开始日期2024-12-30

申办/合作机构-

ChiCTR2400093323

/ Recruiting临床4期IIT

Study on gastrointestinal adverse reactions associated with myelopathic chemotherapy treated by Netopitam-palonosetron combined with fennel kosher salt acupoint hot compress

开始日期2024-12-02

申办/合作机构

四川大学华西医院（四川省国际医院）

100 项与盐酸帕洛诺司琼相关的临床结果

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100 项与盐酸帕洛诺司琼相关的转化医学

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100 项与盐酸帕洛诺司琼相关的专利（医药）

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902

项与盐酸帕洛诺司琼相关的文献（医药）

2025-01-01·JOURNAL OF CLINICAL PHARMACOLOGY

Efficacy of Low‐Dose Scopolamine and Palonosetron in Reducing Immediate Post‐Gastrointestinal Endoscopy Nausea and Vomiting: A Prospective, Randomized, Controlled Study

Article

作者: Lin, Yingzi ; Lin, Jianghuai ; Cai, Zhiming ; Wu, Huanghui ; Gu, Yu

Abstract:

This study aimed to assess the incidence of post‐discharge nausea and vomiting (PDNV) following sedation with nalbuphine and etomidate and to evaluate the prophylactic effects of scopolamine in reducing PDNV. A two‐stage prospective clinical trial was conducted. The first part involved an observational study of 77 subjects to assess the PDNV incidence post‐sedation with nalbuphine, etomidate, and propofol. The second part compared the effectiveness of palonosetron 0.075 mg (P group), scopolamine 0.1 mg (S group), and their combination (PS group) in reducing PDNV. The primary endpoint was the incidence of PDNV within 8 h post‐sedation. Secondary outcomes included PDNV frequency and severity at 8–24, 0–24, and 24–48 h and side effects of medications. The incidence of PDNV within 8 h post‐sedation was 37.66% (29/77). The PS group showed a significantly lower PDNV rate of 2.56% within 8 h, compared to the P group (35.71%, P < .001), S group (19.64%, P < .001), and control group (38.39%, P < .001), respectively. The S group (19.64%) also had a lower rate than the P group (35.71%, P = .007) and the control group (38.39%, P = .002). Subgroup analysis suggested a potential differential effect of palonosetron in reducing vomiting among male patients undergoing gastrointestinal procedures. The combination therapy was also associated with fewer cases of mild or no nausea and vomiting. In summary, the incidence of PDNV following sedation with nalbuphine and etomidate was notably high. The combination of scopolamine and palonosetron was more effective in preventing PDNV, with implications for improved post‐sedation care.

2024-12-15·Journal of minimally invasive surgery

Comparison of efficacy and safety between palonosetron and ondansetron to prevent postoperative nausea and vomiting in patients undergoing laparoscopic surgery: a systematic review and meta-analysis

Article

作者: Lal, Babu ; Rai, Anshul J ; Karna, Sunaina Tejpal ; Barathi, Arivarasan ; Verma, Dinesh Kumar ; Shakti, Prateek ; Yadav, Vineeta ; Kumar, Jitendra ; Goel, Pankaj ; Joshi, Rajnish ; Alagarsamy, Ragavi ; Yunus, Md.

Purpose:

Postoperative nausea and vomiting (PONV) is a prevalent and distressing complication, especially in laparoscopic surgeries. This review compares the efficacy and safety of palonosetron and ondansetron in preventing PONV after laparoscopic surgery.

Methods:

A systematic review was conducted in PubMed, Google Scholar, Semantic Scholar, and Cochrane Library to identify comparative studies that reported the efficacy (nausea and vomiting) at three postoperative time points T1 (0-2 hours), T2 (2-6 hours), T3 (6-24 hours) and safety (incidence of adverse effects). Meta-analysis of relative risk was performed using a random effect model and subgroup analysis based on factors such as antiemetic dose and timing of administration, type of surgery, and anesthetic agents.

Results:

Twenty-one randomized controlled trials were published between 2011 and 2022, involving 2,043 participants. Nineteen trials were included in the meta-analysis (efficacy, 17; safety, 11). The pooled risk ratio revealed that patients receiving palonosetron demonstrated significantly less likelihood of developing nausea and vomiting at various postoperative time points. Subgroup analysis indicated significantly less PONV when palonosetron was administered before intubation and in combination with isoflurane anesthesia. Headache, dizziness, constipation, and drowsiness were the most commonly reported. The safety profiles of palonosetron and ondansetron were comparable.

Conclusion:

Palonosetron exhibits superior efficacy within the first 24 hours postoperatively and requires less rescue antiemetic intervention compared to ondansetron in laparoscopic surgery patients. Both demonstrate nearly comparable safety profiles. Future trials focusing on cardiac safety (QT interval) and cost consideration are needed.

2024-12-01·International Journal of Clinical Oncology

Efficacy and safety of dexamethasone sparing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy: a systematic review and meta-analysis of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology

Review

作者: Wada, Makoto ; Nakamura, Naoki ; Okita, Kenji ; Tanaka, Ryuhei ; Takeda, Masayuki ; Okuyama, Ayako ; Nakashima, Kazuhisa ; Nishimura, Junichi ; Imamura, Chiyo K ; Noda, Mayumi ; Higashi, Takahiro ; Iino, Keiko ; Hayashi, Kazumi ; Satomi, Eriko ; Nakajima, Takako Eguchi ; Matsumoto, Yoko ; Sasaki, Hidenori ; Matsumoto, Koji ; Abe, Masakazu ; Kim, Yong-Il ; Yamamoto, Nobuyuki ; Aogi, Kenjiro ; Imamura, Chiyo K. ; Murakami, Michiyasu ; Yokomizo, Ayako ; Iihara, Hirotoshi ; Ozawa, Keiko ; Boku, Narikazu ; Akechi, Tatsuo ; Kim, Yong-il

BACKGROUND:

Palonosetron, a second-generation 5-HT₃ receptor antagonist (5-HT₃RA), is more effective than first-generation 5-HT₃RA. Several studies have investigated whether dexamethasone (DEX), when combined with palonosetron as a 5-HT₃RA, can be spared in the delayed phase after moderately emetogenic chemotherapy (MEC). In this systematic review, we aimed to determine which between 1- and 3-day DEX administration, when combined with palonosetron, is more useful in patients receiving MEC.

METHODS:

The PubMed, Cochrane Library, and Ichushi-Web databases were searched for relevant studies published between 1990 and 2020. We included studies that compared the efficacy of 1- and 3-day DEX administration in preventing nausea and vomiting associated with MEC. Outcomes were "prevention of vomiting (complete response rate and no vomiting rate)," "prevention of nausea" (complete control rate, total control rate, no nausea rate, and no clinically significant nausea rate)" in the delayed phase, "prevention of blood glucose level elevation," and "prevention of osteoporosis."

RESULTS:

Eight studies were included in this systematic review. The no vomiting rate was significantly higher in the 3-day DEX group than in the 1-day DEX group. However, the other efficacy items did not significantly differ between the two groups. Meanwhile, insufficient evidence was obtained for "prevention of blood glucose level elevation" and "prevention of osteoporosis."

CONCLUSIONS:

No significant differences in most antiemetic effects were found between 1- and 3-day DEX administration. Thus, DEX administration could be shortened from 3 days to 1 day when used in combination with palonosetron.

114

项与盐酸帕洛诺司琼相关的新闻（医药）

2025-01-09

·GlobeNewswire-Health Care

Helsinn Group and ESTEVE sign a partnership agreement renewal to commercialize AKYNZEO® and ALOXI® in Germany

January 8, 2025 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, and ESTEVE, an international specialty pharma company with a focus on highly specialized treatments that address significant unmet medical needs, today announced the signing of the Distribution and Licence Agreement renewal in Germany for AKYNZEO® (combination of netupitant-palonosetron) and ALOXI® (palonosetron) for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. Klaus Schwarz, Managing Director of ESTEVE Germany, commented: “We are delighted to have signed this long-term agreement with Helsinn and are proud to continue our well-established collaboration. Together, we will ensure continued support for patients in Germany throughout their cancer journey by providing access to AKYNZEO® and ALOXI®, essential supportive care products. Looking ahead, we are excited about the future possibilities of this partnership as we strive to innovate and expand our efforts to improve patient care and outcomes.” Dr. Melanie Rolli, Helsinn Group CEO, commented: “We are pleased to announce our renewed partnership with ESTEVE, which marks a significant milestone. Our shared vision and values, coupled with our unwavering commitment to supportive care, will continue to drive our mission to improve the quality of life for cancer patients. We are excited about the new opportunities that lie ahead and look forward to building on our already strong and enduring foundation with ESTEVE.” AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics. ALOXI® is approved in Europe in adults for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. ALOXI® is also indicated in pediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. For additional information please see the EU Summary of Product Characteristics. ESTEVE (www.esteve.com) is a global pharmaceutical company with a clear purpose: to improve people’s lives. Founded in 1929 and headquartered in Barcelona, Spain, ESTEVE has a strong international presence with pharmaceutical affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA. As a leading international specialty pharma company, ESTEVE is focused on delivering highly specialized treatments that address significant unmet medical needs in several therapeutic areas. In addition to our innovative pharma business, we offer comprehensive Contract Manufacturing services, specializing in the production of Active Pharmaceutical Ingredients (APIs) through world-class facilities in Spain, Mexico, and China. ESTEVE’s strong commitment to its core values—people matter, transparency, and accountability—remains at the heart of everything it does. Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. The content above comes from the network. if any infringement, please contact us to modify.

上市批准引进/卖出

2025-01-02

·ioncology

ADC消化道不良反应的预防和处理

点击上方蓝字关注我们编者按：抗体偶联药物（ADC）在众多实体瘤领域带来了许多突破性进展，已经广泛影响临床实践。ADC整体的不良反应低于化疗，但不良反应谱仍与化疗有较多重叠，比如恶心、呕吐、腹泻等消化道症状，可发生于化疗和ADC中。本文总结了ADC的消化道不良反应机制、临床特点、分级处理和监管等。消化道不良反应是ADC较为常见的不良反应之一。ASCENT研究[1]显示戈沙妥珠单抗（SG）组患者腹泻、恶心和呕吐的发生率分别为58%、52%和36%，高于化疗组的6%、24%和6%。DESTINY系列研究的汇总分析[2]显示，T-DXd组的恶心和呕吐发生率分别为74.6%和41.6%，但大多数为1-2级，主要发生在治疗前3周，且数据截止时66.9%的恶心患者与87.6%的呕吐患者症状完全缓解。了解ADC的消化道不良反应特征和处理，有助于协助患者完成治疗，提高治疗依从性。 ADC消化道不良反应的机制和临床特点《中国乳腺癌抗体药物偶联物安全性管理专家共识》[3]指出：胃肠道黏膜的高增殖指数使其特别容易受到化疗不良反应的影响。而靶向治疗也可独立诱导一系列胃肠道不良反应，当与传统化疗药物联合应用时，可增强后者诱导的不良反应。需注意的是，胃肠道HER2受体的主要功能是参与维护黏膜层的完整性，HER2单克隆抗体能够与其发生交叉反应，因此导致不良反应。此外，伊立替康治疗期间早发型腹泻（用药后6h 内）与胆碱能反应相关，迟发型腹泻（用药后超过24h）则主要由于再生的SN-38在肠黏膜内的累积。该共识同时指出，恶心、呕吐和腹泻等消化系统不良反应在戈沙妥珠单抗治疗的患者中较为常见和严重。戈沙妥珠单抗相关的任何等级腹泻至发生与持续的中位时间分别为14天和8天，≥３级腹泻分别为15和6天。T-DXd和T-DM1也有胃肠道不良反应报告，严重程度相对较轻。 ADC消化道不良反应的分级和处理恶心、呕吐、腹泻等消化道不良事件的分级及其处理、结局如下表[3]所示。表1. 消化道不良事件的分级和处理[3] ADC消化道不良反应的监测管理腹泻戈沙妥珠单抗说明书黑框警告提示严重腹泻的可能性，应监测并根据需要给予液体和电解质。《中国乳腺癌抗体药物偶联物安全性管理专家共识》[3]建议戈沙妥珠单抗开始治疗前推荐预先使用止吐剂。若无禁忌证，可以使用阿托品对任何严重程度的早发型腹泻进行预处理和控制。在出现迟发型腹泻时，应评估感染原因，若未发现其他诱因，立即使用洛哌丁胺，首次使用剂量为4mg，以后每次腹泻发作使用2mg，每天最多使用剂量为16mg。腹泻缓解12h后停用洛哌丁胺。对于腹泻不缓解的患者，如前述洛哌丁胺4mg＋2mg，每 2h给予1次；24h若无好转，改用奥曲肽100～150mg，３次/d。重度腹泻应考虑住院。呕吐戈沙妥珠单抗、T-DXd等药物治疗期间均可发生呕吐、恶心不良反应。较早前ASCO、NCCN、意大利等国际指南共识将T-DXd作为中度致吐药物而需进行预防性治疗[4]；而《中国肿瘤药物治疗相关恶心呕吐防治专家共识（2023年版）》[5]将戈沙妥珠单抗、T-DXd列为高度致吐风险药物。同时，该共识将5-HT3RA+NK-1RA+奥氮平+地塞米松（1A类证据）、5-HT3RA+NK-1RA+地塞米松（1A类证据）、帕洛诺司琼+奥氮平+地塞米松（1A类证据）作为高度致吐风险药物的I级推荐；将5-HT3RA+地塞米松（1A类证据）、5-HT3RA+NK-1RA+地塞米松（1A类证据）、帕洛诺司琼+奥氮平+地塞米松（1A类证据）作为中度致吐风险的I级推荐预防用药。表2. 不同程度恶心呕吐的预防策略用药推荐[4] 恶心意大利专家共识[3]指出，恶心的发生存在重要的主观心理因素，且4-5级严重事件极其罕见。对于有过恶心经历的患者，可能会产生治疗偏见，临床需做好沟通。对于这类预期性恶心的治疗主要是从首次用药开始进行有效预防，有效的医患沟通和支持以及针灸等其他辅助治疗可能会有所帮助。 ▌参考文献： [1]Carey, L. A., Loirat, D., Punie, K., et al. (2022). Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer-phase 3 ASCENT study subanalysis. NPJ breast cancer, 8(1), 72. [2]Yeon Hee Park, Javier Cortés, Shanu Modi, et al. Pooled analysis on characteristics of nausea and vomiting in patients receiving trastuzumab deruxtecan (T-DXd) in clinical studies. 2024 ASCO abstract 12118. [3]中国医师协会肿瘤医师分会乳腺癌学组,中国抗癌协会国际医疗交流分会.中国乳腺癌抗体药物偶联物安全性管理专家共识[J].中华肿瘤杂志,2022,44(9):913-927.DOI:10.3760/cma.j.cn112152-20220521-00360. [4]Bianchini G,Arpino G,Biganzoli L,et al.Emetogenicity of Antibody-Drug Conjugates in Solid Tumors with a Focus on Trastuzumab Deruxtecan:Insights from an Italian Expert Panel.Cancers(Basel).2022 Feb 17;14(4):1022. [5]中国抗癌协会癌症康复与姑息治疗专业委员会,中国抗癌协会肿瘤临床化疗专业委员会,中国抗癌协会肿瘤支持治疗专业委员会,中国临床肿瘤学会肿瘤支持与康复治疗专家委员会.中国抗肿瘤治疗相关恶心呕吐预防和治疗指南（2023版）[J].中华肿瘤杂志,2024,46(6):481-501.DOI:10.3760/cma.j.cn112152-20240123-00046. 材料编码 CN-20250102-00003 本资料仅供医疗卫生专业人士参考，请勿向非医疗卫生专业人士发放（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。

抗体药物偶联物临床结果

2024-12-30

·摩熵医药

海思科爆发！7亿+注射剂拿下首家过评，6款1类新药猛攻百亿市场……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月27日，据NMPA官网最新公示，辽宁海思科制药提交的盐酸纳美芬注射液一致性评价补充申请获批，为该品种首家过评药企。据摩熵医药数据库显示，该品种在2023年全国院内市场的销售额超7亿元。截图来源：摩熵医药（原药融云）过评药品汇总数据库盐酸纳美芬注射液用于完全或部分逆转阿片类药物的作用，包括由天然的或合成的阿片类药物引起的呼吸抑制，治疗已知或疑似阿片类药物过量。超7亿注射剂，国内市场竞争激烈盐酸纳美芬注射液在美国市场早已崭露头角，自1995年获批上市以来，一直备受关注。2022年，其首仿药也成功获批上市，持证商为Purdue Pharma LP。转战国内市场，盐酸纳美芬注射液同样展现出强劲的市场潜力。据摩熵医药数据库的最新数据显示，2023年，该药品在全国院内市场的销售额已突破7亿元，成为业内瞩目的焦点。截图来源：摩熵医药（原药融云）全国医院销售数据库然而，随着市场的不断扩大，竞争也日益激烈。目前，国内已有9家药企拥有盐酸纳美芬注射液的生产批文，包括成都苑东生物、北京四环制药等知名药企。但在这场激烈的竞争中，仅辽宁海思科制药凭借出色的研发实力和严格的质量控制，成功拿下国内首家过评，为公司在国内市场的进一步发展奠定了坚实的基础。截图来源：摩熵医药（原药融云）中国药品批文数据库在仿制药布局方面，盐酸纳美芬注射液有江苏安必生制药、成都百裕制药、山东如至生物医药18家药企提交了3类新注册仿制申请，均在审评审批中。截图来源：摩熵医药（原药融云）中国药品审评数据库目前，海思科有31个品种过评，其中首家过评有15款。2024年至今有盐酸纳美芬注射液、复方氨基酸注射液(18AA-Ⅶ)、盐酸帕洛诺司琼注射液、培哚普利吲达帕胺片15款品种过评，其中盐酸纳美芬注射液是今年公司首个首家过评的品种。 6款1类新药猛攻百亿市场，16款1类新药持续在研海思科以“创新”为基石，持续加大研发投入，着力推进创新药研发进程。截至目前，公司已成功斩获25款1类新药的临床试验批文，其中有6款神经系统的1类新药，涉及HSK-21542注射液、苯磺酸克利加巴林胶囊、环泊酚乳状注射液、HSK-21542片、HSK-36357胶囊及环泊酚。据摩熵医药数据库最新数据显示，2023年全国院内神经系统用药市场销售额已超过800亿元，彰显了该领域巨大的市场潜力与需求。截图来源：摩熵医药（原药融云）全国医院销售数据库此外，海思科尚有16款1类新药正稳步推进于临床及临床以上的研究阶段。具体而言，这16款新药中，有1款已提交临床申请，2款正申请上市，8款正处于I期临床试验阶段，4款进入II期临床，另有1款已迈入III期临床的关键阶段。这些创新药物广泛涵盖了麻醉镇痛、肿瘤治疗、呼吸系统疾病、代谢性疾病等多个重要医疗领域，展现了海思科在药物研发领域的广泛布局与深厚实力。海思科凭借出色的研发实力和严格的质量控制，在仿制药和创新药领域均取得了显著成就。未来，随着更多新药的上市和研发推进，海思科将在医药市场中扮演更加重要的角色，为患者带来更多的健康福音。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

一致性评价上市批准

100 项与盐酸帕洛诺司琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05343	盐酸帕洛诺司琼	A04AA05	DB00377

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
恶心	中国	齐鲁制药有限公司	2008-05-04
呕吐	中国	齐鲁制药有限公司	2008-05-04
术后恶心呕吐	澳大利亚	Juniper Biologics Pte Ltd.	2006-06-26
化疗引起的恶心和呕吐	美国	Helsinn Healthcare SA	2003-07-25

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
肿瘤	临床3期	美国	Helsinn Healthcare SA	2017-05-03
胶质瘤	临床2期	美国	Eisai, Inc.	2008-05-01
脑恶性胶质瘤	临床2期	美国	Eisai, Inc.	2008-05-01
淋巴瘤	临床2期	美国	Eisai, Inc.	2007-10-01
转移性黑色素瘤	临床2期	美国	Eisai, Inc.	2006-11-01
多发性骨髓瘤	临床2期	美国	Eisai, Inc.	2006-03-01
多发性骨髓瘤	临床2期	美国	Helsinn Healthcare SA	2006-03-01
急性髓性白血病	临床2期	美国	Eisai, Inc.	2005-09-01

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临床结果

适应症

分期

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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


CTRI/2023/04/051951 (phase IV Indian study, ESMO2024)	临床4期	-	178	IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA)	膚憲鏇願顧鬱憲遞壓襯(鏇鬱範蓋艱襯夢壓廠鹽) = 4, 2.25% 簾觸糧餘憲簾夢淵鑰餘 (簾艱製遞襯膚繭鏇製窪 ) 更多	积极	2024-09-15
ESMO 12023 \| ESMO 22023 人工标引	临床2期	乳腺癌	76	Palonosetron+aprepitant+ olanzapine	鏇積夢襯簾繭餘蓋選餘(網夢願繭齋憲衊製鑰製) = 鑰遞網選齋顧遞獵齋築膚製顧壓衊夢淵構遞願 (繭壓鑰鹹膚窪遞選窪遞, 9.4 ~ 27.5) 更多	不佳	2023-10-21
NCT03040726 (CTgov)	临床2/3期	恶心 \| 肿瘤 \| 呕吐	53	Palonosetron (NEPA)+Netupitant (Blinded Intervention Group)	壓觸鹽艱窪齋網網鏇鏇(鏇構鏇憲齋構繭網築繭) = 製鹹鹹顧鏇築窪繭衊壓製繭衊襯製鹹淵糧構窪 (糧壓衊顧積艱構鹽醖鑰, 窪觸糧壓糧構觸製繭鏇 ~ 顧夢衊壓鹽願鑰艱膚築) 更多	-	2023-10-17
				Placebo (Blinded Placebo Group)	壓觸鹽艱窪齋網網鏇鏇(鏇構鏇憲齋構繭網築繭) = 壓築築廠選鬱網夢膚觸製繭衊襯製鹹淵糧構窪 (糧壓衊顧積艱構鹽醖鑰, 窪夢範衊顧窪夢壓鏇範 ~ 淵醖網範築鏇築網襯鹹) 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))	艱餘選遞製廠憲顧製衊(憲製構獵網艱積觸鑰廠) = 餘壓鹹願淵觸築憲願鏇膚餘願鑰鬱積艱鏇壓遞 (糧醖糧餘選壓壓襯鑰餘, 積製醖願鏇夢齋鑰願簾 ~ 艱遞鹹憲襯選獵積選艱) 更多	-	2023-05-08
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	艱餘選遞製廠憲顧製衊(憲製構獵網艱積觸鑰廠) = 憲鑰壓鹹製襯窪艱範繭膚餘願鑰鬱積艱鏇壓遞 (糧醖糧餘選壓壓襯鑰餘, 簾窪壓餘願襯廠觸鏇窪 ~ 齋製艱繭餘簾糧淵餘廠) 更多
NCT03817970 (ASN2022)	临床3期	肾脏毒性	23	Ondansetron 8 mg p.o.	鏇鏇糧夢獵襯醖膚繭糧(觸膚鑰憲顧製鹽顧積鬱) = 鹽築糧壓壓鬱壓膚鹽鬱鏇衊鹽壓廠蓋網廠範築 (選範觸鬱醖鏇膚襯淵網 ) 更多	不佳	2022-11-04
				Palonosetron 0.25 mg i.v.	鏇鏇糧夢獵襯醖膚繭糧(觸膚鑰憲顧製鹽顧積鬱) = 選築壓夢壓淵壓窪膚築鏇衊鹽壓廠蓋網廠範築 (選範觸鬱醖鏇膚襯淵網 ) 更多
NCT04669132 (OLNEPA, ASCO2022) 人工标引	临床2期	化疗引起的恶心和呕吐	48	Olanzapine + Netupitant + Palonosetron	壓醖積積蓋選鹽廠鑰夢(艱製膚遞艱窪繭網鹽糧) = 糧壓齋鏇獵觸憲鏇淵範醖憲鹽鹹遞醖鹽積齋憲 (構壓廠夢積淵糧築範膚, 32 ~ 59) 更多	积极	2022-06-02
NCT00967499 (CTgov)	临床2期	术后恶心呕吐	239	Palonosetron (Palonosetron)	齋艱鏇繭糧觸獵構鏇艱(鑰選鹹艱廠網築願壓繭) = 廠淵積鏇蓋簾鬱壓憲顧獵築襯鹹衊製遞鬱選鏇 (觸構憲窪繭齋範窪築壓, 簾選選範鬱襯範築醖憲 ~ 齋鑰憲壓廠壓餘簾廠願) 更多	-	2021-01-11
				Ondansetron (Ondansetron)	齋艱鏇繭糧觸獵構鏇艱(鑰選鹹艱廠網築願壓繭) = 鹽積憲淵顧齋製夢鑰築獵築襯鹹衊製遞鬱選鏇 (觸構憲窪繭齋範窪築壓, 壓築蓋製網構蓋夢繭壓 ~ 鹽糧壓齋鬱鏇襯獵衊醖) 更多
NCT01054456 (CTgov)	临床2期	化疗引起的恶心和呕吐 \| 术后恶心呕吐 \| 呕吐	36	palonesetron	壓網獵膚膚衊構製蓋襯(築糧鹽築襯範鹽鑰構網) = 衊鹽鹽糧鹽構選獵鹽齋糧構艱夢夢鹽廠鹹憲獵 (窪築窪衊鹹餘繭艱蓋壓, 餘構繭鏇壓願蓋衊壓簾 ~ 膚築壓鑰壓範構窪淵觸) 更多	-	2020-12-23
NCT03204279 (CINV, CTgov)	临床2期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 ... 更多	67	Palonosetron+Netupitant (Netupitant 1.33 mg/kg Plus Palonosetron)	廠構壓膚網鹹壓鬱衊觸(齋積餘衊鏇製廠鬱願夢) = 構顧鏇鹽壓築觸積簾餘繭獵衊遞遞齋淵廠窪窪 (獵齋襯廠鬱築糧獵餘鹽, 鏇顧鹽範構構願獵繭夢 ~ 積鹽糧鹹醖構顧鏇憲齋) 更多	-	2020-12-07
				Palonosetron+Netupitant (Netupitant 4 mg/kg Plus Palonosetron)	窪製膚壓鹹膚餘餘範餘(膚衊獵鑰餘衊齋襯鹹糧) = 遞醖蓋顧選觸觸觸範壓觸膚夢顧淵遞鏇構衊構 (獵窪積構願觸艱築範蓋, 鬱選襯積蓋淵衊製選觸 ~ 願膚構鹹襯製鏇積壓醖) 更多
ESMO_ASIA_VIRTUAL2020	N/A	食管癌	-	Palonosetron 0.25 mg	鹹範積觸鑰廠鹹顧積選(鬱簾範齋範鏇襯餘簾淵) = Grade 2-3 constipation and any grade of aspartate aminotransferase increase were more frequently observed in 0.75 mg group (38% vs. 58%, p < 0.05; 7% vs. 22%, p < 0.05) 餘鹽獵獵膚網獵壓餘鹹 (構範膚鑰簾簾築壓選鑰 )	积极	2020-11-22
				Palonosetron 0.75 mg