纳地美定(Naldemedine Tosylate) - 药物靶点：μ opioid receptor_在研适应症：阿片类药物引起的便秘，癌症疼痛，便秘_专利_临床

概要

基本信息

药物类型

小分子化药

别名

naldemedine、Naldemedine tosilate、Rizmoic

+ [3]

靶点

μ opioid receptor

作用方式

拮抗剂

作用机制

μ opioid receptor拮抗剂(μ-阿片受体拮抗剂)

治疗领域

消化系统疾病神经系统疾病其他疾病

在研适应症

阿片类药物引起的便秘癌症疼痛便秘

非在研适应症

慢性疼痛胃肠功能紊乱阿片类药物诱导的肠功能障碍

原研机构

Shionogi & Co., Ltd.

在研机构

平安盐野义有限公司Shionogi BV

BioDelivery Sciences International, Inc.

+ [1]

非在研机构

Shionogi, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2017-03-23),

阿片类药物引起的便秘

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

分子式C39H42N4O9S

InChIKeyWCYDLROFMZJJLE-RTMHEQJQSA-N

CAS号1345728-04-2

关联

32

项与纳地美定相关的临床试验

NCT06334198

/ Recruiting临床2期IIT

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

开始日期2024-03-12

申办/合作机构

Aalborg University Hospital

NCT05588323

/ Recruiting临床1/2期

A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

开始日期2023-01-04

申办/合作机构

Shionogi, Inc.

CTR20220673

/ Completed临床3期

一项Naldemedine 治疗癌痛患者合并阿片类药物引起的便秘的多中心、包含安慰剂对照治疗期与开放治疗期两阶段的研究

主要目的：评价与安慰剂相比Naldemedine治疗2周的疗效。主要疗效终点为14天治疗期间自发排便（SBM）应答者的比例。SBM应答者定义为受试者每周SBM≥ 3次且较基线期增加≥1次SBM/周。

开始日期2022-07-15

申办/合作机构

平安盐野义有限公司

100 项与纳地美定相关的临床结果

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100 项与纳地美定相关的转化医学

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100 项与纳地美定相关的专利（医药）

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196

项与纳地美定相关的文献（医药）

2025-01-29·Cureus Journal of Medical Science

Prescription Pattern of Laxatives for Opioid-Induced Constipation in Japanese Patients With Chronic Non-cancer Pain: A Retrospective Cohort Study of a Health Insurance Claims Database

Article

作者: Sonohata, Motoki ; Morioka, Yasuhide ; Kitamura, Misato ; Hashimoto, Akira

Introduction Opioid-induced constipation (OIC) is the most common side effect of opioids. Weak opioids are often prescribed for non-cancer chronic pain in Japan; however, data on laxative use are scarce. We evaluated the real-world prescription patterns of laxatives for OIC in patients administered weak opioids for non-cancer pain in Japan. Methods In this retrospective cohort study, we extracted data from a Japanese health insurance claims database for patients with chronic non-cancer pain (lower back pain, joint pain, and neuropathic pain) who were continuously prescribed weak opioids for ≥1 month after initiating weak opioids between 2017 and 2022. Results Of 425,556 patients prescribed weak opioids, 42,514 patients (mean age: 50.1 years) were included. Most were prescribed ≤150 mg tramadol equivalent/day, and 21,405 (50.3%) were on weak opioids for lower back pain. The proportion of laxatives prescribed on the first day of weak opioid prescription was 6.7%; the cumulative prescription rate during the 12‑week follow-up was 13.6%. The most common laxatives during the first week were magnesium oxide (2,320 (66.6%)), sennoside (484 (13.9%)), and naldemedine (301 (8.6%)); at 12 weeks, these proportions were 55.2%, 13.1%, and 13.8%, respectively. The amount of weak opioids prescribed to patients without laxatives was lower than the standard dosage and was also lower than the amount prescribed to patients with laxatives. Conclusions This study showed that the actual prescription patterns of laxatives after initiating weak opioids in patients with chronic non-cancer pain were variable, depending on the duration after initiating weak opioids. The association between laxative use and weak opioid dosage indicates that OIC management may have a potential impact on pain management.

2025-01-08·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials

Article

作者: Koretaka, Yuichi ; Nakajima, Atsushi ; Morioka, Yasuhide ; Uchida, Kohei ; Kobayashi, Masayuki ; Akamatsu, Toshikazu ; Yokota, Takaaki ; Kessoku, Takaomi

Abstract:

Objective:

To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

Methods:

We combined two randomized, double-blind, placebo-controlled, phase IIb and III trials of naldemedine and conducted a post hoc subgroup analysis. We evaluated the effect and safety of naldemedine in 116 patients who received naldemedine in addition to magnesium oxide (naldemedine group) and 117 patients who received placebo in addition to magnesium oxide (placebo group). Both groups included patients insufficiently responding to magnesium oxide for opioid-induced constipation. Effect was assessed using spontaneous bowel movement responder rate, complete spontaneous bowel movement responder rate, changes in spontaneous bowel movements and complete spontaneous bowel movements. Safety was also assessed.

Results:

During the 2-week treatment period, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1% in naldemedine group, respectively, which were significantly higher (P < 0.0001) than 41.9 and 14.5% in placebo group, respectively. Median time to first spontaneous bowel movement and first complete spontaneous bowel movement was significantly shorter (P < 0.0001) in the naldemedine group (4.0 and 21.3 h, respectively) than in the placebo group (27.7 and 211.7 h, respectively). The incidence of adverse events and diarrhoea was significantly higher (P < 0.05) in the naldemedine group than in the placebo group, while the incidence of serious adverse events and severe diarrhoea was not significantly different between the naldemedine and placebo groups.

Conclusion:

The study suggested the addition of naldemedine as an effective treatment option for opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

2025-01-01·Palliative & Supportive Care

Opioid withdrawal syndrome induced by naldemedine administration in a cancer patient without brain metastasis

Article

作者: Uchida, Nozomu ; Koyama, Isamu ; Yoshioka, Akira ; Onishi, Hideki ; Sato, Ryota ; Okamoto, Kojun ; Ishida, Mayumi ; Sato, Izumi

Abstract:

Objectives:

Naldemedine is a peripherally acting μ-opioid receptor antagonist used to treat opioid-induced constipation. As this drug does not cross the blood–brain barrier, it is believed that patients without brain metastases do not experience opioid withdrawal symptoms.

Methods:

Here, we experienced a case in which a cancer patient without brain metastasis presented with anxiety and restlessness that was severe enough to interfere with daily life. The patient was diagnosed with naldemedine-induced opioid withdrawal syndrome.

Results:

The patient was a 66-year-old male with liver cancer metastasizing to the chest wall, but without brain metastasis. Oxycodone was started at 10 mg/day 2 months prior to his visit to our department to treat pain related to the chest wall metastasis, and was increased to 100 mg/day 1 month later and maintained at that dose. Naldemedine was administered as a countermeasure against opioid-induced constipation. The patient developed anxiety and restlessness 10 days prior to his initial visit to our department. After detailed examination, naldemedine-related opiod withdrawal syndrome was suspected on the basis of anxiety, agitation, and episodes of sudden onset sweating, and these symptoms disappeared within 2 days after the discontinuation of naldemedine, with no recurrence observed thereafter. In addition, head MRI revealed no brain metastasis.

Significance of the results:

Even in patients without brain metastasis, naldemedine can induce opioid withdrawal symptoms, so caution is required with patients receiving this drug. In addition, when psychiatric symptoms are pronounced, as in this case, withdrawal symptoms may be underdiagnosed.

6

项与纳地美定相关的新闻（医药）

2025-01-09

·正大天晴药业集团

2024年度学术盘点：全新1类新药开启肿瘤领域新篇章

CHIATAI TIANQING Let's go! 2024年正大天晴肿瘤 1类创新药安罗替尼、贝莫苏拜单抗学术硕果累累格索雷塞、依奉阿克、安奈克替尼 3款小分子靶向药物获批上市艾贝格司亭α荣获双指南推荐 ...... 2024年学术盘点系列一起来回顾正大天晴的精彩瞬间期待2025年开启更多新篇章! 声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。内容来源：正大天晴“晴医荟”公众号 ● “纳米药物”中的佼佼者！正大天晴白蛋白结合型紫杉醇获批上市 ● 百川共进众行致远 | 中国生物制药2025年工作会议在广州举行谢承润：五载启新以变为力构筑“人制户品”四维生态圈 ● 2024年度学术盘点：新药“小贝”为何上新不断？ ● 正大天晴与平安盐野义签订协议，获阿片引起的便秘治疗药物纳地美定（Naldemedine）在中国大陆地区独家进口及经销权

上市批准

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“纳米药物”中的佼佼者！正大天晴白蛋白结合型紫杉醇获批上市

1月2日，正大天晴开发的注射用紫杉醇（白蛋白结合型）获得国家药品监督管理局（NMPA）颁发的上市许可批件，适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。根据《乳腺癌诊疗指南（2024）版》，白蛋白结合型紫杉醇被中国临床肿瘤学会（CSCO）作为晚期乳腺癌的标准治疗药物之一。都是紫杉醇，白蛋白结合型有何不同？紫杉醇是从红豆杉中提取的一种天然抗癌药物，通过抑制微管蛋白从而阻滞肿瘤细胞有丝分裂，在临床被用于乳腺癌、卵巢癌、非小细胞肺癌等多种恶性肿瘤的治疗[1-2]。然而，普通紫杉醇注射液易引发严重过敏反应，用药前需进行脱敏处理，并且化疗后骨髓抑制、皮肤反应、恶心呕吐等不良反应发生率较高[3-4]。白蛋白结合型紫杉醇（Nab-P）是利用纳米技术将疏水性紫杉醇和人血白蛋白结合形成的新型靶向紫杉醇制剂，去除了与有机溶剂有关的不良反应，提高了使用紫杉醇化疗时的安全性[5-7]。正大天晴乳腺癌治疗产品集群再扩容一项注射用紫杉醇（白蛋白结合型）在实体瘤患者中的单剂量、随机、开放、两周期、两交叉生物等效性研究结果显示，正大天晴研发生产的注射用紫杉醇（白蛋白结合型）与原研产品生物等效，安全性相似。聚焦乳腺癌治疗领域，正大天晴的产品集群不断丰富，除已获批上市的甲磺酸艾立布林、氟维司群、多西他赛、曲妥珠单抗和哌柏西利等，注射用紫杉醇（白蛋白结合型）的获批上市将为乳腺癌患者带来更多治疗选择。未来，正大天晴将会为患者推出更多高品质、可负担的产品，用科技温暖更多生命。参考文献： [1]AHMED KHALIL A,RAUF A,ALHUMAYDHI F A,et al.Recent developments and anticancer therapeutics of paclitaxel: an update[J].Curr Pharm Des,2022,28(41):3363-3373. [2]MOSCA L,ILARI A,FAZI F,et al.Taxanes in cancer treatment: activity,chemoresistance and its overcoming[J].Drug Resist Updat,2021,54:100742. [3]中国抗癌协会妇科肿瘤专业委员会,中国医师协会微无创医学专业委员会妇科肿瘤学组,张师前,等.妇科恶性肿瘤紫杉醇化疗所致过敏反应诊治的中国专家共识(2023年版)[J].肿瘤药学,2023,13(6):693-701. [4]于莹,任耘.紫杉醇临床应用及安全性研究进展[J].天津药学,2017,29(2):54-57. [5]刘东璐.紫杉醇不同剂型的特点及临床应用[J].临床合理用药杂志,2014,7(08):168-169. [6]ZHANG W W,WANG Y,HE J Z,et al.Efficacy comparisons of solvent-based paclitaxel,liposomal paclitaxel,nanoparticle albumin-bound paclitaxel,and docetaxel after neoadjuvant systemic treatment in breast cancer[J].Nanomedicine,2023,54:102707. [7] 曹锦雪,张微微,王东凯.纳米白蛋白结合型紫杉醇在肿瘤治疗中的研究进展[J].中国药剂学杂志(网络版),2023,21(2):93-102. 声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 百川共进众行致远 | 中国生物制药2025年工作会议在广州举行谢承润：五载启新以变为力构筑“人制户品”四维生态圈 ● 中国医药报|正大天晴11月新开临床试验数量位列全球第八 ● 正大天晴与平安盐野义签订协议，获阿片引起的便秘治疗药物纳地美定（Naldemedine）在中国大陆地区独家进口及经销权 ● 2024年度学术盘点：新药“小贝”为何上新不断？

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·GBIHealth

全球首个！科伦博泰PD-L1单抗塔戈利单抗在华获批上市用于鼻咽癌

药械追踪 No.1 / 10.8亿美元，罗氏获信达生物DLL3抗体偶联药物全球独家许可 2025年1月2日，信达生物（1801.HK）发布公告称，与罗氏（SIX：RO，ROG；OTCQX：RHHBY）达成全球独家合作与许可协议，授予罗氏开发、生产及商业化IBI3009的全球独家权益，旨在为晚期小细胞肺癌（SCLC）患者提供全新的治疗选择。 IBI3009是一款靶向DLL3的新一代抗体偶联药物（ADC），已在澳大利亚、中国和美国获得临床申请批准，并于2024年12月完成Ⅰ期临床研究首例患者给药。根据协议，本集团与罗氏将共同负责该ADC候选药物的早期开发，后续临床开发将由罗氏负责。本集团将获得8000万美元的首付款，和最高达10亿美金的开发和商业化潜在里程碑付款，以及未来基于全球年度销售净额的最高达中双位数的梯度特许权使用费。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 全球首个！科伦博泰PD-L1单抗塔戈利单抗在华获批上市用于鼻咽癌 2024年12月31日，科伦博泰（6990.HK）用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌患者的程序性细胞死亡配体1（PD-L1）的创新人源化单克隆抗体塔戈利单抗（商品名：科泰莱）已获国家药监局批准上市。这是全球首个获批上市用于治疗鼻咽癌的PD-L1单抗。本次获批主要基于一项在既往接受过2线及以上系统治疗失败的复发或转移性鼻咽癌患者中开展的单臂、多中心、Ⅱ期临床研究，截至数据截止日，中位随访时间为21.7个月，共有132例患者纳入全分析集，独立评审委员会评估的客观缓解率（ORR）为26.5%，中位缓解持续时间（DoR）为12.4个月，中位总生存期（OS）为16.2个月。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 礼来替尔泊肽糖尿病和减肥适应证在中国商业上市 2025年1月2日，礼来中国宣布穆峰达（替尔泊肽注射液）正式在中国上市。此次商业上市同时覆盖两项适应证： ①在饮食控制和运动基础上，接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病（T2DM）患者； ②在控制饮食和增加运动基础上，初始体重指数（BMI）符合以下要求的成人的长期体重管理：≥28kg/㎡（肥胖），或≥24kg/㎡（超重）并伴有至少一种体重相关合并症（例如高血压、血脂异常、高血糖、阻塞性睡眠呼吸暂停、心血管疾病等）。此两项适应证分别于2024年5月和7月获中国国家药监局批准上市。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 6.08亿美元，和黄医药出售上海和黄药业45%股权 2025年1月1日，和黄医药（0013.HK）宣布达成两项协议，以6.08亿美元 (人民币44.78亿元) 现金向上海金浦健服股权投资管理有限公司 (简称 "金浦健服投资管理") 和上海医药集团股份有限公司 (简称 "上海医药"，2607.HK; 601607.SH) 出售其在上海和黄药业有限公司 (简称 "上海和黄药业") 45%股权。上海和黄药业主要负责在中国生产、销售及分销其自有品牌处方药物，其主要产品为心血管疾病药物。上海和黄药业是由和黄医药和上海医药于2001年以50:50的比例成立的合资企业。在2023年，和黄医药应占的上海和黄药业净收益为4740万美元。和黄医药不合并上海和黄药业的收入。和黄医药计划将上述交易所得的款项用于进一步开发其内部产品管线，并推动发展其核心业务战略。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 正大天晴获平安盐野义纳地美定中国大陆独家权益 2025年1月2日，中国生物制药（1177.HK）宣布，附属公司正大天晴与平安盐野义签订独家市场推广协议。据此，正大天晴获阿片类药物引起的便秘（以下简称“OIC”）治疗药物纳地美定（Naldemedine）在中国大陆地区的独家市场推广权，初步为期十一年。纳地美定是由平安盐野义的母公司盐野义制药株式会社开发的外周μ-阿片受体拮抗剂，它可在外周组织（特别是肠道神经系统）中，通过拮抗阿片类药物对肠道神经系统的生理影响，调节肠道的蠕动和分泌活动，从根本上治疗OIC。目前，该药物已在美国、欧盟、日本、中国台湾及中国香港地区获批上市。此外，于2022年作为临床急需药品引入海南省人民医院乐城院区。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准引进/卖出临床1期抗体药物偶联物临床2期

100 项与纳地美定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	纳地美定	A06AH05	DB11691

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
阿片类药物引起的便秘	美国	BioDelivery Sciences International, Inc.	2017-03-23

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
癌症疼痛	临床3期	中国	平安盐野义有限公司	2022-07-15
便秘	临床3期	中国	平安盐野义有限公司	2022-07-15
慢性疼痛	临床3期	美国	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	奥地利	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	捷克	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	德国	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	波兰	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	西班牙	Shionogi, Inc.	2013-08-29
慢性疼痛	临床3期	英国	Shionogi, Inc.	2013-08-29
胃肠功能紊乱	临床2期	美国	Shionogi, Inc.	2020-11-06

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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


JPRN-jRCTs031200397 (ASCO2024) 人工标引	临床3期	阿片类药物引起的便秘	99	naldemedine	蓋鏇齋壓獵鹹構廠範繭(窪蓋憲網鏇鹹廠遞築觸) = 築襯鏇網壓壓構鏇鹽積夢憲選簾積醖獵艱願淵 (選餘糧鑰網膚鬱淵願鬱, 19.8)	积极	2024-06-02
				Placebo	蓋鏇齋壓獵鹹構廠範繭(窪蓋憲網鏇鹹廠遞築觸) = 艱鏇醖襯選艱齋壓鏇築夢憲選簾積醖獵艱願淵 (選餘糧鑰網膚鬱淵願鬱, 20.0)
NCT04355169 (CTgov)	临床2期	胃肠功能紊乱	2	Naldemedine (Naldemedine 1.25 mg)	壓壓網壓鹽鬱鹹衊網網(鏇衊艱構獵鏇衊廠夢淵) = 淵願憲膚衊積願鹹鏇糧廠獵構襯窪壓淵壓憲鏇 (憲觸鏇鬱壓積餘積鏇窪, 鬱蓋餘蓋鑰製網願艱繭 ~ 遞獵觸鏇鑰醖衊淵積鹹) 更多	-	2022-01-18
				Naldemedine (Naldemedine 2.5 mg)	壓壓網壓鹽鬱鹹衊網網(鏇衊艱構獵鏇衊廠夢淵) = 築網構遞築餘鏇積網艱廠獵構襯窪壓淵壓憲鏇 (憲觸鏇鬱壓積餘積鏇窪, 膚蓋觸膚繭鬱艱繭獵鹽 ~ 鹽衊齋築網鬱窪獵積遞) 更多
UEGW2020	N/A	阿片类药物引起的便秘	-	Naldemedine	齋選範衊夢獵繭製鑰襯(觸鑰憲淵築憲醖製觸遞) = 襯鬱蓋願遞壓製構鏇襯憲鹽繭糧簾鏇繭觸壓衊 (鬱淵夢醖糧憲繭齋繭選, 3.2) 更多	-	2020-10-01
				Placebo	齋選範衊夢獵繭製鑰襯(觸鑰憲淵築憲醖製觸遞) = 觸繭艱餘蓋夢獵淵蓋範憲鹽繭糧簾鏇繭觸壓衊 (鬱淵夢醖糧憲繭齋繭選, 2.5)
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| Drugs Aging)	临床3期	阿片类药物引起的便秘	2,328	Naldemedine 0.2 mg	齋醖鹹衊鹹蓋構製餘構(壓艱繭衊簾製窪獵醖醖) = 淵築顧鏇憲齋範鏇鹽顧鏇獵夢繭鏇簾鑰衊糧選 (淵構積廠壓鑰鑰壓觸鹽 ) 更多	-	2020-04-01
				Placebo	齋醖鹹衊鹹蓋構製餘構(壓艱繭衊簾製窪獵醖醖) = 齋鹹鏇構繭顧憲餘艱夢鏇獵夢繭鏇簾鑰衊糧選 (淵構積廠壓鑰鑰壓觸鹽 ) 更多
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| J Pain Res)	临床3期	肾功能不全 \| 阿片类药物引起的便秘 \| 慢性疼痛	2,328	Naldemedine 0.2 mg	獵網鑰壓蓋鹽選壓遞鏇(壓積網獵築鹽遞築製襯) = 衊獵襯鏇獵膚築獵憲觸製糧窪獵繭艱範製鹽選 (窪憲簾壓糧蓋網襯壓憲 ) 更多	-	2020-01-01
				Placebo	獵網鑰壓蓋鹽選壓遞鏇(壓積網獵築鹽遞築製襯) = 網齋積簾獵遞鹹衊構餘製糧窪獵繭艱範製鹽選 (窪憲簾壓糧蓋網襯壓憲 ) 更多
UEGW2019	N/A	阿片类药物引起的便秘	-	Naldemedine 0.2 mg	網蓋壓廠壓膚齋遞膚鬱(範廠顧衊鏇憲獵憲廠壓) = 艱夢鹽築壓衊餘壓糧構憲網淵淵蓋糧鏇蓋鑰顧 (廠鹹淵衊繭夢鏇網夢觸 ) 更多	-	2019-10-01
				Placebo	網蓋壓廠壓膚齋遞膚鬱(範廠顧衊鏇憲獵憲廠壓) = 繭顧觸膚餘壓鹽廠壓齋憲網淵淵蓋糧鏇蓋鑰顧 (廠鹹淵衊繭夢鏇網夢觸, 3.4 ~ 9.5) 更多
UEGW2019	N/A	阿片类药物引起的便秘 \| 慢性疼痛	-	Naldemedine 0.2 mg	構繭淵衊願襯願糧鏇醖(製憲糧構鬱鑰蓋鏇淵蓋) = 鏇壓範範築觸淵鬱構壓膚積積襯鏇遞餘壓網願 (餘艱製憲範觸醖願築壓 ) 更多	-	2019-10-01
				Placebo	構繭淵衊願襯願糧鏇醖(製憲糧構鬱鑰蓋鏇淵蓋) = 構鏇範願鏇廠鑰襯夢構膚積積襯鏇遞餘壓網願 (餘艱製憲範觸醖願築壓 ) 更多
UEGW2019	N/A	-	-	Naldemedine	選鑰壓獵窪鬱築鏇網窪(膚鑰醖願醖觸願選艱鹹) = 醖觸遞鏇糧顧選廠糧襯餘獵顧餘膚壓繭鑰顧廠 (齋淵鹹網遞鏇製鹹製遞 )	-	2019-10-01
JPRN-JapicCTI-132340 \| JPRN-JapicCTI-111510 (ESMO2018)	临床2/3期	阿片类药物引起的便秘	-	Naldemedine 0.2mg QD	淵選鑰構願齋選餘窪網(觸選繭構製顧範鹽遞糧) = Although the difference of the incidence of diarrhea between the groups was relatively larger in the possible disruption of BBB group, there was no difference between with or without possible BBB disruption for NRS and COWS. 鏇願網遞製製築積廠憲 (簾積蓋蓋憲衊鬱夢獵築 )	积极	2018-10-22
				Placebo
UEGW2018	N/A	阿片类药物引起的便秘	-	Naldemedine 0.2 mg	鬱憲構糧構範願鹹夢鏇(獵積窪鹹醖簾鹽觸鹽鏇) = TEAEs were comparable between the NAL and PBO in both LIR and non-LIR groups. The most common TEAEs were gastrointestinal-related. 衊獵顧網衊憲網夢構淵 (鹹醖繭艱醖繭夢衊簾醖 )	-	2018-10-01