The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.

开始日期2024-01-23

申办/合作机构

The General Hospital Corp.

[+1]

NCT05922358 / Not yet recruiting临床2期IIT

Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study

The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

开始日期2023-09-01

申办/合作机构

福建省肿瘤医院

NCT05298683 / Not yet recruiting临床2期

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

This is an investigator-initiated (IIS), phase 2, prospective, open-label, multinational study, designed to be conducted in approximately 14 sites. Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone.
Following this phase:
Patients who achieve ≥VGPR will be randomized in a 1:1 ratio to receive isatuximab, given either Q2W or once monthly, plus pomalidomide and low-dose dexamethasone.
Patients with The study will last for 42 months (recruitment and follow-up period), starting from the date of the first patient in (FPI) to the date of the last patient last visit (LPLV).
Core study procedures consist of baseline and post-baseline safety and disease evaluations, including physical examination, hematologic/clinical chemistry tests, radiologic assessments, bone marrow evaluations, and blood/urine M-protein assessments.
Patients will be allowed to continue treatment until disease progression, death, unacceptable AEs, lost to follow-up, or consent withdrawal.

开始日期2022-05-01

申办/合作机构

Hellenic Society of Cardiology

[+1]

100 项与盐酸雷尼替丁相关的临床结果

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100 项与盐酸雷尼替丁相关的转化医学

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100 项与盐酸雷尼替丁相关的专利（医药）

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4,575

项与盐酸雷尼替丁相关的文献（医药）

2024-03-01·Therapie

Drug-induced tumoral disease: A global pharmacovigilance database analysis

Article

作者: Despas, Fabien ; Zelmat, Yoann

INTRODUCTION:

Cancer remains a worldwide threat, having caused almost 10 million deaths in 2020. The American Cancer Society has identified both known and probable carcinogens, including commonly used drugs. The aim of this study is to describe the drugs most frequently reported in the occurrence of cancer.

METHODS:

Among all individual case safety reports (ICSRs) in the global pharmacovigilance database VigiBase, we searched for the 50 most reported drugs with an adverse drug reaction term belonging to the query "Malignant or unspecified tumors" until June 30, 2023. Then, we extracted the disproportionality measurement data, information component (IC), and reporting odds ratio (ROR) in order to assess a disproportionality signal.

RESULTS:

Among all ICSRs in VigiBase, 871,925 contained an ADR belonging to the SMQ "Malignant or unspecified tumors". Ranitidine was the drug with the most reported ADRs related to cancer (n=106,484), followed by lenalidomide (n=13,466), and etanercept (n=8014). The drugs with the highest IC were ranitidine (IC=5.2, 95% confidence interval [95% CI]=5.2-5.2), pioglitazone (1353 ICSRs, IC=4.2, 95% CI=4.2-4.2), and regorafenib (1272 ICSRs, IC=2.8, 95% CI=2.8-2.8).

DISCUSSION:

Our results show that the main pharmacological mechanisms are associated with ranitidine (link with levels of N-nitrosodimethylamine in ranitidine-based drugs), gene-activating drugs (pioglitazone: link with agonist effects on PPAR-γ gene activation), various pharmacological families with immunosuppressive effects (protein kinase inhibitors, immunomodulators, azathioprine, etc.), certain types of protein kinase inhibitors whose oncogenic mechanisms remain unclear (regorafenib, sorafenib, imatinib, ibrutinib, etc.), and hormone antagonists (tamoxifen, letrozole). Special monitoring of patients exposed to these drugs may be required. Further studies are needed to assess the risk with certain drugs in this ranking.

Molecular and cellular biochemistry

Inhibitors of gastric acid secretion increase oxidative stress and matrix metalloproteinase-2 activity leading to vascular remodeling

Article

作者: Nogueira, Renato C ; Tanus-Santos, Jose E ; Oliveira-Paula, Gustavo H ; Sanches-Lopes, Jéssica M

The use of inhibitors of gastric acid secretion (IGAS), especially proton pump inhibitors (PPI), has been associated with increased cardiovascular risk. While the mechanisms involved are not known, there is evidence supporting increased oxidative stress, a major activator of matrix metalloproteinases (MMP), as an important player in such effect. However, there is no study showing whether other IGAS such as histamine H2-receptor blockers (H2RB) cause similar effects. This study aimed at examining whether treatment with the H2RB ranitidine promotes oxidative stress resulting in vascular MMP activation and corresponding functional and structural alterations in the vasculature, as compared with those found with the PPI omeprazole. Male Wistar rats were treated (4 weeks) with vehicle (2% tween 20), omeprazole (10 mg/Kg/day; i.p.) or ranitidine (100 mg/Kg/day; gavage). Then the aorta was collected to perform functional, biochemical, and morphometric analysis. Both ranitidine and omeprazole increased gastric pH and oxidative stress assessed in situ with the fluorescent dye dihydroethidium (DHE) and with lucigenin chemiluminescence assay. Both IGAS augmented vascular activated MMP-2. These findings were associated with aortic remodeling (increased media/lumen ratio and number of cells/μm²). Both IGAS also impaired the endothelium-dependent relaxation induced by acetylcholine (isolated aortic ring preparation). This study provides evidence that the H2RB ranitidine induces vascular dysfunction, redox alterations, and remodeling similar to those found with the PPI omeprazole. These findings strongly suggest that IGAS increase oxidative stress and matrix metalloproteinase-2 activity leading to vascular remodeling, which helps to explain the increased cardiovascular risk associated with the use of those drugs.

2024-02-01·Journal of hazardous materials

Oxidation of amine-based pharmaceuticals with unactivated peroxymonosulfate: Kinetics, mechanisms, and elimination efficiency of NDMA formation

Article

作者: Zeng, Zhu ; Fu, Junhao ; Gao, Yuan ; Zhou, Yang ; Ma, Jinxing ; Zhang, Zhong ; Han, Bin ; Jiang, Jin

Amine-based pharmaceuticals are a significant class of N-nitrosodimethylamine (NDMA) precursors. This study investigated the use of unactivated peroxymonosulfate (PMS) to control amine-based pharmaceuticals and their NDMA formation potential. Kinetic analysis and product identification revealed that sumatriptan and doxylamine primarily underwent reactions at their tertiary amine group, while ranitidine and nizatidine had both tertiary amine and thioether group as reaction sites. The NDMA formation from sumatriptan and doxylamine during post-chloramination was significantly reduced with the abatement of the parent contaminants, while the formation of NDMA remained high even if full abatement of ranitidine and nizatidine was achieved. Product formation kinetics and reference standard tests revealed the great contribution of transformation products to NDMA formation. Ranitidine could be oxidized to sulfoxide-type product ranitidine-SO and N-oxide type product ranitidine-NO. Ranitidine-SO exhibited a high NDMA yield comparable to that of ranitidine (>90%), while ranitidine-NO showed a low NDMA yield (2%). With further oxidation of ranitidine-SO at the tertiary amine group, NDMA formation was reduced by more than 90%. The underlying mechanism for the importance of the tertiary amine group in NDMA formation was demonstrated by quantum chemical calculation. These findings underscore the potential of PMS pre-oxidation on NDMA control.

152

项与盐酸雷尼替丁相关的新闻（医药）

2024-06-19

·药事纵横

仿制药研发中的专利挖掘——分析方法篇

实际工作中如何找到我们的发明点或者如何挖掘创新点申请专利保护呢？首先我们要了解一下什么是专利挖掘，专利挖掘是指从现有研发项目或技改项目中提炼出具有创新点的技术方案，并将所提炼的技术方案用专利化的语言进行描述并申请专利以获得专利保护。仿制药的药学研究包括原料药、制剂和分析研发三大块，前面已经介绍了原料药和制剂研发过程中的专利挖掘，本文主要阐述分析方法研发过程的专利挖掘。分析是项目研发人员的眼睛，用于判断项目研发的好坏，分析方法建立的成功与否很大程度上影响着整个项目的进展，因此在整个项目研发中占有绝对的地位。分析方法虽然在项目研发中很重要，但研发人员往往缺少专利挖掘的意识，很多研发成果没有形成专利。下文将结合案例具体探讨分析方法研发过程的可专利点。有关物质检测不论是原料还是制剂，分析方法研发的重点和难点基本都在有关物质。有关物质分析方法开发的过程简单的说就是解决如何准确定量目标物中潜在杂质的问题，这就要求方法分离度好、灵敏度高、重现性好、易于操作等，解决这些问题的过程也就是形成我们专利发明点的过程。一种测定鲁比前列酮供试品有关物质的分析方法专利，申请人为南京正大天晴制药，申请号为201811580995.8。该专利主要解决的技术问题是提供一种能准确测定鲁比前列酮供试品有关物质含量的高效液相色谱分析方法。本发明建立的检测方法，溶剂不干扰杂质检测，鲁比前列酮5个已知杂质可以准确定量，主峰与相邻杂质峰的分离度≥1.2、各杂质间的分离度≥1.5，方法专属性良好，且该检测方法简便、快速、准确、灵敏度高、重复性好、准确度好。异构体检测手性药物是指分子结构中含有手性中心（也叫不对称中心）的药物。由于手性药物的不同立体异构体在药效、药代及毒理等方面都可能存在差异，因此在质量研究中要重点关注。因为手性药物不同异构体特殊的结构特点，特别是对于光学异构体，其和主药成分为映像关系，同主峰分离非常困难，建立准确可靠的检测方法是一项非常具有挑战性的工作。一种替格瑞洛对映异构体、非对映异构体的分离检测方法的发明专利，申请人为江苏恒瑞医药，申请号为201611087850.5，主要保护一种替格瑞洛对映异构体、非对映异构体的分离检测方法。现有技术报道了分离检测替格瑞洛非对映异构体的方法，但该方法存在对替格瑞洛对映异构体的分离度不好，载量性差，结果重现性差等问题。本发明所提供的一种替格瑞洛对映异构体、非对映异构体检测方法，以纤维素衍生物为填充剂的色谱柱为手性色谱柱，低级烷烃与低级醇混合液为流动相，通过高效液相色谱法对替格瑞洛对映异构体、非对映异构体进行分离测定。该检测方法具有较高的准确度和精密度，耐用性强，适合医药工业上替格瑞洛异构体的检查及质量控制。基因毒质检测基因毒性杂质（genotoxic impurities，GTI）又称遗传毒性杂质，是指化合物本身能直接或间接损伤细胞DNA，产生基因突变或体内诱变，具有致癌可能或者倾向。近年来随着制药行业接连从缬沙坦、雷尼替丁、二甲双胍等药物中发现亚硝胺类基因毒杂质残留，监管部门对基因毒杂质的监管越来越严格。因基因毒性杂质能改变人体DNA、自身反应性强的特点，对其限度控制往往比较低。检测过程受基质干扰大，对仪器的灵敏度高，如何保证检测结果的准确性也成了分析时需要解决的问题。一种拉莫三嗪潜在基因毒性杂质的分析方法的专利申请，申请人为浙江华海药业，申请号为202110035529.7，主要保护一种拉莫三嗪潜在基因毒性杂质的分析方法。在拉莫三嗪的合成工艺中，有1个可能属于潜在基因毒性杂质，按照每日摄入量限度为1.5微克/天计算其在成品中限度指标为2.14ppm，使用常规的紫外检测器灵敏度无法达到要求。采用GC‑MS或LC‑MS方法检测时，发现由于检测灵敏度不够，或是在高温下发生分解或聚合等原因，无法在2ppm限度内对该杂质进行准确定量。本发明开发了拉莫三嗪样品中微量潜在基毒杂质分析方法，采用检测前先用可离子化或质子化的胺类衍生试剂对该潜在基因毒性杂质进行柱前衍生，然后在酸性检测条件下用LC‑MS方法进行检测，可以使该杂质的检测灵敏度达到0.2ppm以下。该方法抗干扰能力强，操作简单，并且灵敏度高，线性范围宽，可以快速有效地检测拉莫三嗪或其中间体样品中微量潜在基毒杂质二氯苯甲酰腈的含量，有利于有效的控制拉莫三嗪药品中潜在基毒杂质的残留，保护患者的用药安全。残留溶剂药物中的残留溶剂系指在原料药或辅料的生产中、以及在制剂制备过程中使用或产生而又未能完全去除的有机溶剂。根据国际化学品安全性纲要，以及美国环境保护机构、世界卫生组织等公布的研究结果，很多有机溶剂对环境、人体都有一定的危害，因此，为保障药物的质量和用药安全，以及保护环境，需要对残留溶剂进行研究和控制。实际方法开发中经常面临灵敏度低、干扰峰、峰形不好或重复性差等问题。一种利用顶空气相色谱法检测罗库溴铵中残留溶剂的方法专利，申请人为江苏盈科生物制药有限公司，申请号为201810517861.5。在现有技术中，关于罗库溴铵产品中残留溶剂的气相检测，顶空方法多采用DMSO、DMF等溶剂，方法不够环保。与现有技术相比，本发明的检测罗库溴铵中残留溶剂的方法具有环保、便捷的独特优势。同时本发明方法灵敏度高、专属性强、检测结果准确可靠的优点，可以准确评价罗库溴铵的产品质量。其他检测方法虽然分析方法开发难点多在药品杂质方面，专利申请也多集中在以上几个方面，但也不是说其他分析方法就不能申请专利，只要方法有创新性、解决了特定的技术问题都可以形成专利进行保护。一种稳定的非离子型碘造影剂的含量测定方法，申请人为南京正大天晴制药，申请号为202010196316.8。碘帕醇是一种非离子低渗透单体，显影作用良好，是一种临床广泛应用的造影剂。但是由于其黏度大，对于其制剂中的碘含量进行测定一直是困扰技术领域人员的难点，现有的测定法有滴定法和高效液相色谱法，但是，由于其测定时间长，操作复杂，非常受限于操作人员的经验水平。本发明采用密度值作为测定参数，数据采集方便快捷，分析结果准确，可克服常规滴定以及高效液相分析方法操作繁琐，过程耗时，重复性差等缺点；而且本发明方法也不需准备和使用任何化学试剂，环保，高效。一种难溶注射剂细菌内毒素的检测方法专利申请，申请人为浙江华海药业，申请号为201911118605.X。细菌内毒素是热原的主要代表物质，是注射用药物的重点控制项目。凝胶法是2015版中国药典收录的细菌内毒素检查法之一，使用鲎试剂来定性检测内毒素。这种检测方法易操作、准确性好、实用性较强。采用凝胶法检测难溶注射剂中的细菌内毒素时，因难溶注射剂粉末不溶于细菌内毒素检查用水，难溶注射剂粉末中包裹的细菌内毒素无法提取出来，导致无法准确检测产品中内毒素含量。本发明方法采用二氯甲烷等有机溶剂将难溶注射剂粉末溶解后，再使用细菌内毒素检查用水萃取有机溶剂中的细菌内毒素进行检测，该方法可以有效提取难溶性注射剂中的细菌内毒素，实现难溶性注射剂细菌内毒素检测，而且采用的有机溶剂不干扰检测，避免了现有技术中有机溶剂干扰检测的问题，方法操作简便，准确性高，重现性好，对保证注射剂的安全性具有非常重要的意义。小结：综上结合案例对分析方法研发中可专利性挖掘进行了梳理，可见即使是做仿制药在仿的过程中仍然会遇到很多问题，仍然有很多创新点，仍然可以形成自己的知识产权。分析方法专利挖掘的关键是要找准发明所要解决的技术问题，解决该技术问题所采用的技术手段，以及相比现有技术采用本发明技术手段所带来的技术效果。当以上几点弄明白之后，我们的专利框架基本也就确定了。参考文献： 1、国家知识产权局专利数据库 2、化学药物杂质研究的技术指导原则 3、手性药物质量控制研究技术指导原则 4、朱文泉, 马健, 李敏. 基因毒性杂质的挑战与控制策略——从ICH指导纲领到实际操作层面[J]. 中国食品药品监管, 2020(12):16. 5、化学药物残留溶剂研究的技术指导原则药事纵横投稿须知：稿费已上调，欢迎投稿

2024-06-11

·FiercePharma

GSK notches Zantac win in Illinois, appeals high-stakes setback in Delaware

GSK on Monday reiterated its stance that “there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.” As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday, GSK said in an online statement. GSK did not settle Kasza’s claim and stressed that it did not pay her anything for her voluntary dismissal, according to the company's statement. The drugmaker said it will continue to “vigorously defend itself” in the ongoing litigation. The company reiterated its stance that “there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.” Ranitidine is the former main ingredient in Zantac, which quality assurance lab Valisure first linked to the possible carcinogen N-nitrosodimethylamine (NDMA) back in 2019. The FDA ultimately called for a complete purge of the original Zantac formulation from the U.S. market in April 2020. GSK is the original developer of Zantac and gained approval for the med back in 1983, turning it into a blockbuster and the world’s bestselling drug by 1988. When the drug lost patent exclusivity in 1997, Pfizer, Sanofi, Boehringer Ingelheim and others began selling generic versions until the FDA’s 2020 ranitidine kibosh. Earlier this month, a Delaware judge allowed more than 75,000 lawsuits against various drugmakers to proceed when she ruled that juries in the state can hear expert analyses of the potential health risks caused by Zantac. At the time, ODDO BHF analysts claimed GSK could face potential exposure worth $2 billion if the company were to settle the tens of thousands of claims it faces. Despite the legal setback in Delaware, GSK has been able to win or parry various other Zantac claims in recent months. In late May, a Chicago jury sided with GSK and Boehringer when it rejected the claim of Angela Valadez that the heartburn drug had led to her colon cancer. In February, GSK settled two separate Zantac personal injury lawsuits in California. Prior to that, GSK in October said it had resolved another four cases in the Golden State, one of which was set to go to trial in November. Sanofi, for its part, agreed to settle approximately 4,000 personal injury claims related to Zantac in early April, while Pfizer charted a similar move to knock out some 10,000 lawsuits in several U.S. state courts in May. Apart from the Kasza case, GSK was set to face another jury trial in Illinois this month from a plaintiff claiming Zantac caused his prostate cancer, plus another prostate cancer personal injury claim from a plaintiff in Illinois in July, according to the company's first-quarter earnings release. As for the Delaware decision, GSK on Monday added that it plans to appeal the so-called Daubert ruling, which allows for plaintiff expert testimony as part of the Zantac litigation in the state. Pfizer, Sanofi and Boehringer joined GSK in filing the application to the Delaware Supreme Court against what the companies deemed an “inconsistent” application of the standard. The Delaware Supreme Court is expected to issue a decision on whether to grant the drugmakers’ request for interlocutory review “sometime later this year,” GSK said. Editor's note: This story was updated with additional detail on GSK's decision to appeal the recent Daubert ruling in Delaware.

上市批准专利侵权优先审批

2024-06-05

·药渡

股价一度跌近10%，市值蒸发80亿美元！GSK或将面临巨额索赔

前言：凭借着带状疱疹、RSV疫苗的大卖，超长效IL-5抗体三期临床结果顶线等消息面影响，GSK的股价在近两个月内一路走高。可好景不长，一个困扰了GSK七年之久的梦魇，使其股市再次动荡，一日蒸发掉80亿美元市值。雷尼替丁致癌风波 2024年6月3日，GSK在伦敦市场，早盘一度大跌9.8%，创下2023年以来最大跌幅。起因是，美国特拉华州法院裁定，将继续审理7万起针对GSK与旗下停售药物Zantac的诉讼。 Zantac即雷尼替丁，从1981年首次上市至2018年，累计销售额974.2亿美元。由GSK原研，是其第一款“重磅炸弹”药物西咪替丁的进阶版。 2019年9月，美国独立实验室 Valisure 在执行检测时发现雷尼替丁样品中N-亚硝基二甲胺（NDMA，世卫组织将其归为2A类致癌物质）含量超标，后向 FDA 提交公民情愿呼吁 FDA 要求制药商暂停销售并召回产品。 2019至2020年间，雷尼替丁陆续在市场中被召回。后经GSK、FDA、EMA等多方研究人员对现有数据进行了广泛审查发现，没有证据表明雷尼替丁治疗与患者癌症发展之间存在因果关系。梳理一下就是，雷尼替丁确实存在NDMA超标的情况，但没有证据证明服用雷尼替丁可增加癌症诱发风险。诉讼案始末雷尼替丁虽然原研是GSK，但公司后续又与辉瑞、勃林格殷格翰、赛诺菲等药企达成了相关商业合作。因此，这些公司都收到了类似诉讼。而笔者以诉讼内容将其分为主要两类：“知情不报类”与“诱发癌症类”。所谓知情不报类，以Valisure为主导，他的诉讼论点是“GSK此前知道亚硝胺风险，但故意隐瞒并向FDA瞒报”；第二种诱发癌症类，数量最多，既往用过雷尼替丁治疗，且如今患癌的人群都可以成为申诉对象。 2022年12月，佛罗里达地区法院驳回了2500 起诉讼，认为原告的证据缺乏实验记录、逻辑连贯性以及统计学上的显著数据，无法证明雷尼替丁是否真的致癌。这一判决使得各大药企暂时免受了50000起诉讼的压力，但这并不能打消所有原告的上诉情绪，路透社2023年10月就报道了79000起未决案件。时间拉回至2024年，雷尼替丁致癌的诉讼案再次迎来转机。辉瑞、赛诺菲同时于今年，就相关案件达成和解。前者同意支付2.5亿美元，以解决10000多起雷尼替丁相关的肿瘤风险诉讼，后者同意赔偿约4000起相关索赔案件，以解决除特拉华州以外的所有美国州法院的诉讼，具体金额不详。但据路透社报道，在特拉华州，赛诺菲还将面临约25000起诉讼，而GSK则还有69000起。来自GSK的申明通常，达成和解是让投资者放心并避免可能旷日持久且代价高昂的诉讼的一种手段。那么GSK想要达成和解，就需要开支一大笔费用，部分分析认为这笔费用的金额可能为30至50亿美元不等。 2024年6月1日，GSK发布紧急申明，阐述了对特拉华州法院裁决结果的不满，具体包括：（1）目前没有一致获可靠的证据可以表明雷尼替丁可增加致癌风险（2）此次裁决与2022年裁决结果不一致（3）不服，并立刻、马上需求上诉（4）公司资本配置重点不变。而就在前不久，5月16日，GSK宣布抛售旗下消费者健康公司Haleon（赫力昂）的所有股票。赫力昂成立于2018年，由GSK与辉瑞分拆的消费者健康业务合并而成，2022年从GSK分拆后上市。虽然赫力昂的成立与雷尼替丁无直接关系，但也是受此时间影响成为了GSK的战略调整的一部分。结语 NDMA对药物的影响无疑是巨大的。通常认为NDMA来源需要同时具备二甲胺和亚硝化试剂，在雷尼替丁中发现NDMA的初始阶段，一致认为是制造过程中的引入。在后续检测了不同批次雷尼替丁的NDMA含量（2010~2019年生产），分析得到：（1）NDMA的含量和制造日期有联系，生产日期越早相应的NDMA含量越大（2）原料药中的含量高于制剂中含量，而且同一批次原料药制备成制剂，NDMA的生成速率也会降低。近年来，随着药企与监管部门对潜在基因毒性杂质（PGI）研究和控制的关注度逐步提高，CMC 被一再重视。将此类事件杜绝于出厂之前，减少对患者，以及药企自身的损失。参考资料 1.GSK官网 2.《Biopharma's biggest sellers – the oldies that just keep giving》 3.Zantac官司赢了，一路下坡的GSK可以松口气（蓝精灵壹号） 4.葛兰素史克今日股价暴跌近10%，发生了什么？ 5.Valisure 诉葛兰素史克欺瞒善胃得致癌风险案卷宗解封（识林） 6.其他公开资料点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！

临床3期疫苗

100 项与盐酸雷尼替丁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00673	盐酸雷尼替丁	A02BA02	DB00863

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
反流性食管炎	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1991-08-13
胃泌素瘤	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1991-08-13
局部硬皮病	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1991-08-13
胃溃疡	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1991-08-13
胃酸过多	中国	湖南正清制药集团股份有限公司	1985-01-01
十二指肠溃疡	美国	Glaxo Group Ltd.	1983-06-09
十二指肠溃疡	美国	GSK Plc	1983-06-09

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
HIV感染	临床2期	美国	Glaxo Wellcome, Inc.	1999-11-02

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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


HOPE Study (ISTH2021)	N/A	血友病A	34	prophylaxis	窪壓鹹獵蓋餘構壓鏇鹽(觸選壓膚簾餘衊襯範衊) = 範鹽廠積鏇糧鹹繭選糧鑰窪簾顧鑰選餘憲淵遞 (襯糧築遞醖糧繭簾選糧 )	-	2021-07-17
				prophylaxis	窪壓鹹獵蓋餘構壓鏇鹽(觸選壓膚簾餘衊襯範衊) = 餘觸齋觸醖築簾顧製憲鑰窪簾顧鑰選餘憲淵遞 (襯糧築遞醖糧繭簾選糧 )
NL8173 (ESMO2020)	N/A	-	-	Premedication regimen with ranitidine	獵顧糧窪願築選鏇餘鑰(積繭願簾觸壓艱鑰範築) = 壓選構願獵鬱範廠憲夢範鬱醖鬱蓋壓製糧觸醖 (構築膚鑰積艱餘鏇網鹽 )	积极	2020-09-17
				Premedication regimen without ranitidine	獵顧糧窪願築選鏇餘鑰(積繭願簾觸壓艱鑰範築) = 糧襯淵構鑰簾壓膚糧簾範鬱醖鬱蓋壓製糧觸醖 (構築膚鑰積艱餘鏇網鹽 )
NCT01847001 (CTgov)	临床2期	局部晚期恶性肿瘤 \| 乳腺癌	10	Surgery+Trastuzumab+nab-paclitaxel+CYCLOPHOSPHAMIDE+DOT imaging+doxorubicin+Paclitaxel+Decadron+pertuzumab+ranitidine+Benadryl+Propranolol	餘鹽遞膚膚範齋糧鬱齋(構範淵獵淵鑰鬱積夢窪) = 淵淵網遞網構願襯選夢簾觸積築餘製網憲製鹹 (衊醖鏇憲繭範簾艱積膚, 憲鹹鏇窪獵範觸淵齋願 ~ 糧蓋繭夢簾壓餘憲壓壓) 更多	-	2020-01-10
EULAR2016	N/A	-	24	Ranitidine	餘網衊範築憲膚憲構醖(鬱糧夢壓遞齋鏇膚鹽窪) = 艱鹹築蓋淵蓋鏇範積衊襯淵顧網築鑰鹽齋繭衊 (繭膚顧繭築繭願窪鹽蓋 ) 更多	-	2016-06-08
				Control (saline solution)	餘網衊範築憲膚憲構醖(鬱糧夢壓遞齋鏇膚鹽窪) = 築夢積鹹糧壓淵繭醖築襯淵顧網築鑰鹽齋繭衊 (繭膚顧繭築繭願窪鹽蓋 ) 更多
AAAAI2016	N/A	药物不良反应	-	Ranitidine	鹹鹹廠構鹽鏇蓋壓鹹築(獵遞網顧構齋獵齋構顧) = Among them, 99 patients (17.0%) experienced anaphylaxis 淵積襯範顧繭選醖積餘 (襯積簾鏇蓋繭鏇醖鑰衊 )	-	2016-02-01
NCT00668317 (CTgov)	临床3期	咳嗽 \| 呼吸道过敏	5	Omeprazole+Ranitidine	製鏇獵築簾顧繭鏇鑰廠(觸齋積範壓糧齋遞鏇鏇) = 餘糧糧網廠遞鹹襯積範遞鹽窪築鏇簾餘繭窪顧 (築願築糧積鬱鹹築願壓, 積獵餘蓋鑰鏇範衊鏇鑰 ~ 廠鑰艱淵鏇夢範鏇鹽襯)	-	2012-11-16
ASN2012	N/A	泌尿道感染	490	Prophylactic antibiotics	構網選鹽遞鹽鏇選淵窪(艱糧窪願衊蓋餘衊蓋積) = 艱襯窪衊顧襯憲範鬱範網選膚淵醖遞鹹鏇積觸 (齋鬱積餘壓選憲鬱鑰願 )	不佳	2012-10-30
IMPACT trial (ASN2011)	N/A	巨细胞病毒感染	690	Valganciclovir prophylaxis for high-risk recipients	選窪構廠構衊繭鑰簾鹹(範淵簾衊築顧壓願鹽鬱) = 獵淵網醖構簾壓築醖憲窪憲構蓋選蓋壓鏇顧築 (鏇鬱簾鹹衊夢遞襯壓繭 )	不佳	2011-11-08
				Valganciclovir prophylaxis for intermediate-risk recipients	選窪構廠構衊繭鑰簾鹹(範淵簾衊築顧壓願鹽鬱) = 製膚蓋觸壓構窪廠鹽網窪憲構蓋選蓋壓鏇顧築 (鏇鬱簾鹹衊夢遞襯壓繭 )
Pubmed \| Br Dent J	N/A	十二指肠溃疡 Helicobacter pylori	104	Amoxicillin plus Metronidazole	顧獵壓衊齋繭鑰襯憲鹽(鏇糧窪繭遞鹽繭製構襯) = mainly diarrhea 鹹蓋窪獵鏇鏇膚願簾艱 (糧遞鹽壓窪鏇衊願淵顧 ) 更多	积极	1993-02-04
				Placebo