钆特酸葡胺(Gadoterate Meglumine) - 在研适应症：血管疾病，造影剂，乳腺癌_专利_临床

概要

基本信息

药物类型

造影剂、小分子化药

别名

DOTA-gadolinium meglumine、DOTA-Gd meglumine、Gadolinium-DOTA meglumine

+ [16]

靶点-

作用机制

磁共振成像增强剂

治疗领域

心血管疾病其他疾病肿瘤+ [1]

在研适应症

血管疾病造影剂乳腺癌+ [1]

非在研适应症

中枢神经系统疾病脑动脉疾病终末期肾脏病+ [2]

原研机构

Guerbet France SAS

在研机构

Guerbet Japan KK

Guerbet SAGuerbet LLC

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (2000-09-22),

造影剂

最高研发阶段(中国)批准上市

特殊审评-

登录后查看时间轴

结构/序列

分子式C23H42GdN5O13

InChIKeyRYHQMKVRYNEBNJ-BMWGJIJESA-K

CAS号92943-93-6

关联

43

项与钆特酸葡胺相关的临床试验

CTRI/2024/10/075817

/ Not yet recruiting临床4期

Active surveillance in India of the safety of Dotarem®, a gadolinium-based contrast agent. Post-marketing observational, surveillance study - NA

开始日期2024-11-04

申办/合作机构

Guerbet SA

NCT06532071

/ Recruiting临床2期IIT

Advanced Imaging for Pulmonary Fibrosis

The purpose of this study is to determine if measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.

开始日期2024-11-01

申办/合作机构

The Massachusetts General Hospital

NCT05937776

/ RecruitingN/AIIT

Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects

This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

开始日期2023-12-11

申办/合作机构

OHSU Knight Cancer Institute

[+1]

100 项与钆特酸葡胺相关的临床结果

登录后查看更多信息

100 项与钆特酸葡胺相关的转化医学

登录后查看更多信息

100 项与钆特酸葡胺相关的专利（医药）

登录后查看更多信息

849

项与钆特酸葡胺相关的文献（医药）

2024-11-13·NANO LETTERS

One-Pot Fabrication of Kinetically Inert Ultrasmall Manganese(II) Chelate-Backboned Polymer Contrast Agents for High-Performance Magnetic Resonance Imaging

Article

作者: Liu, Li ; Ni, Guohua ; Fu, Shengxiang ; Younis, Muhammad Rizwan ; Ai, Hua ; Gu, Haojie ; Wu, Min ; Lui, Su ; Cai, Zhongyuan ; Song, Bin

Traditional macromolecules or nanoscale Mn²⁺ chelate-based magnetic resonance imaging (MRI) contrast agents (CAs) suffer from complicated and laborious synthesis processes, relatively low kinetic stability and T₁ relaxivity, limiting their clinical applications. Herein, we fabricated a series of kinetically inert Mn²⁺ chelate-backboned polymers, P(MnL-PEG), through a facile and one-pot polymerization process. Particularly, P(MnL-PEG)-3 demonstrates a significantly higher T₁ relaxivity of 23.9 Mn mM^-1 s^-1 at 1.5 T than that of previously reported small molecules and macromolecules or nanoscale Mn²⁺ chelate-based CAs. Due to its high T₁ relaxivity, extended blood circulation, hepatocyte-specific uptake, and kidneys metabolism, P(MnL-PEG)-3 presents significantly enhanced contrast in blood vessel, liver, and kidneys imaging compared to clinical Gd³⁺-based CAs (Gd-EOB-DTPA and Gd-DOTA) at a dosage of 0.05 mmol Mn/Gd kg^-1 BW, and can accurately diagnose orthotopic H22 liver tumors in vivo in animal models. We anticipate that this work will promote the development of clinically relevant MRI CAs.

2024-10-22·ENVIRONMENTAL SCIENCE & TECHNOLOGY

Formation of Nitrosamines from the Heterogeneous Reaction of Nitrous Acid and Organic Amines in Indoor Environments

Article

作者: Long, Shiqian ; Yang, Xin ; Yuan, Wenting ; Zhao, Wangchao ; Zheng, Guomao ; Zhu, Lei ; Zhang, Lifang ; Zhou, Li ; Xu, Jiwen ; Ye, Jianhuai ; Liu, Chenglin ; Jiao, Xiaoqiao ; Shen, Huizhong ; Yang, Bo ; Huang, Weilin ; Wang, Chen ; Fu, Tzung-May

Carcinogenic nitrosamines have been widely studied due to their risk to human health. However, the universality and evolutionary processes of their generation, particularly concerning their secondary sources, remain unclear at present. We demonstrated through laboratory flow tube experiments that corresponding nitrosamines were generated from heterogeneous reactions of nitrous acid (HONO) with five structurally diverse amines commonly found indoors, including diphenylamine (DPhA), dibenzylamine (DBzA), dioctylamine (DOtA), N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD), and N-phenyl-1-naphthylamine (PANA). The heterogeneous reaction rate constants of DBzA and DOtA with HONO (∼70 ppb) were 1.21 × 10^-3 and 2.13 × 10^-3 min^-1 at 30% relative humidity (RH), resulting in a lifetime of 13.8 and 7.8 h. As compared to higher RH (∼80%), more nitrosamines were produced from the reaction of HONO with surface-sorbed DBzA, DOtA, 6PPD, and PANA at lower RH (30%), with product yields ranging from <0.1% to 0.5%. Furthermore, we observed the formation of nitroso-6PPDs and nitro-6PPDs during room air exposure of 6PPD in a genuine indoor environment, in addition to various other transformation products indicative of reactions of 6PPD with HONO, NOx, and ozone indoors. This study confirmed the universality of the heterogeneous reaction of surface-sorbed amine with HONO as a source of nitrosamines indoors.

2024-09-26·Journal of Physical Chemistry Letters

In Search of Covalency Measure of Gd(III)-Ligand Interactions

Article

作者: Starynowicz, Przemysław ; Siczek, Miłosz ; Janicki, Rafał

Experimental electron density distribution of the [C(NH₂)₃]₃[Gd(EDTA)F₂]·H₂O crystal was determined. The derived experimental and theoretical (DFT) topological parameters such as ∇²ρ_c, ρ_c, bond degree (BD), kinetics, and potential energy were used to study the nature of Gd-O, Gd-F, and Gd-N interactions. The natural charge of the Gd is 1.86; the natural configuration of the cation is [Xe]6s^0.134f^7.105d^0.83, and the covalency of the Gd-L bond is mainly connected with the transfer of charge from the sp^x ligand orbitals onto the 5d orbitals of the Gd cation. Simultaneously, the donation of charge onto the 6s and 4f orbitals occurs to a lesser extent. Moreover it was found that the donation of the ligand charges onto the Gd(III) is larger for compounds with a lower coordination number. The obtained topological parameters were analyzed in the context of the Gd(III) f-f transition properties, i.e., energy of the excited ^2S+1L_J states, Judd-Ofelt intensity parameters, and luminescence lifetimes, of 18 Gd(III) compounds with various O, N, and F donor ligands (DOTA, EDTA, CDTA, DTPA, NTA, EGTA, ODA, F^-, H₂O, and CO₃^2-). The calculated nephelauxetic β parameter may reflect the penetration degree of electron lone pairs of ligands inside the metal basin. Finally, it was found for the first time that the sum of the Gd(III)-L bond energy (∑E_GdL) is correlated with the position of the gravity center of the ⁸S_7/2 → ^2S+1L_J transitions and increase of covalency of the Gd(III)-L bonds is associated with decrease of their bond energy. The obtained results may shed light on chemical bonding in systems containing f-elements. Such subtle differences in the covalent contribution to the Ln-L or An-L bond may tune the selectivity of the partitioning processes of lanthanides and actinides.

95

项与钆特酸葡胺相关的新闻（医药）

2024-12-27

·北陆药业

【喜报】北陆药业荣获“最具人气上市公司TOP300”

近日，2024年同花顺上市公司年度榜单正式公布，北陆药业（股票代码：300016.SZ）荣誉登榜获得2024年度“最具人气上市公司TOP300”奖项。此次荣获奖项，充分彰显了资本市场及广大投资者对北陆药业公司的全面认可与肯定。在“二次创业”理念的引领下，北陆药业积极践行“化药+中药”双轮驱动的业务模式，通过深化中成药领域布局、积极拥抱集采政策以及拓展海外市场等多措并举，推动公司业绩实现稳步增长。今年，公司成功收购承德天原药业80%的股权，实现了在中成药领域的进一步战略布局，目前公司已拥有59个中成药批文，其中九味镇心颗粒和金莲花颗粒两大“黄金单品”销售额过亿。同时，公司海外市场拓展取得显著成效，密云药厂对比剂生产线顺利通过欧盟EU GMP及巴西ANVISA GMP认证。在研发方面，公司不断提升效率，多元化布局研发项目，年内多款产品成功获批上市。未来，公司将继续以成为“中国医药制造百强企业”为中长期发展目标，践行“化药+中药”双轮驱动的业务模式，实现产品多元化，为客户和投资者创造长期、持续的价值增长和业绩回报。往期推荐 01 【喜报】钆特酸葡胺注射液拟中标第十批全国药品集中采购 02 【喜报】北陆药业对比剂生产线通过欧盟GMP认证 03 【喜报】北陆药业通过巴西国家卫生监督局GMP认证识别二维码关注我们

并购带量采购

2024-12-13

·北陆药业

【喜报】钆特酸葡胺注射液拟中标第十批全国药品集中采购

2024年12月12日，公司参加了国家组织药品联合采购办公室组织的第十批全国药品集中采购投标工作，公司钆特酸葡胺注射液拟中标。拟中标产品基本情况对公司的影响公司拟中标产品钆特酸葡胺注射液于2024年获得国家药品监督管理局核准签发的《药品注册证书》，截止目前，该产品未开展销售。本次集中采购是国家组织的第十批药品集中带量采购，采购周期中，医疗机构将优先使用本次药品集中采购中标药品，并确保完成约定采购量。随着确定中选、签订采购合同并实施，钆特酸葡胺注射液有望快速打开市场，进一步提升公司对比剂产品的市场份额和品牌影响力，对公司长远发展将产生积极影响。

带量采购

2024-12-13

·GBIHealth

第十批国家集采拟中标结果公布，无原研中标

药械追踪 No.1 / 和黄医药呋喹替尼在欧洲首次纳入医保，将获得武田1000万美元里程碑付款 2024年12月13日，和黄医药（0013.HK）宣布呋喹替尼用于治疗经治的转移性结直肠癌（mCRC）患者在西班牙获纳入公共医疗保障范围的建议，这是呋喹替尼在欧洲取得的首个纳入公共医疗保障范围的建议。据此，和黄医药将收到一笔来自合作伙伴武田 (TSE: 4502/ NYSE: TAK) 的1000万美元里程碑付款。呋喹替尼是一种选择性针对所有三种VEGFR（VEGFR-1、-2及-3）的口服抑制剂。2023年3月，和黄医药与武田达成独家许可协议，授权武田在中国大陆及港澳以外的全球范围内进一步推进呋喹替尼的开发、商业化和生产。2023年11月，呋喹替尼在美国获批用于经治mCRC患者，2024年6月，呋喹替尼获获欧洲药品管理局（EMA）人用药品委员会（CHMP）批准；2024年9月，呋喹替尼在加拿大获批上市。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 百济神州获石药集团MAT2A抑制剂全球权益 2024年12月13日，石药集团（1093.HK）发布公告称，已与BeiGene Switzerland GmbH（百济神州）就集团旗下新型甲硫氨酸腺苷转移酶2A（MAT2A）抑制剂（SYH2039）达成独家授权合作，百济神州获得在全球开发、制造及商业化该化合物及该产品的独家授权。根据协议条款，石药集团将获得1.5亿美元的预付款，并有权收取最高1.35亿美元的潜在开发里程碑付款及最高15.50亿美元的潜在销售里程碑付款，以及根据该产品的年度销售净额计算的分层销售提成。 SYH2039是本集团通过AI驱动的小分子药物设计平台获得的临床候选药物。该平台通过AI技术分析靶标蛋白与化合物分子的结合模式，对分子成药性进行针对性优化设计，最终筛选得到的高活性、高选择性的小分子MAT2A抑制剂。临床前研究显示，SYH2039可有效抑制非小细胞肺癌、胶质瘤、胃食管癌、胰腺癌和膀胱癌等多种MTAP缺失型肿瘤细胞的生长，具有优异的体内外活性，同时也具有良好的药物动力学（PK）特性和安全性，有潜力成为一款同类最优（best-in-class) 的抗肿瘤药物。SYH2039既可单用，也可与包括PRMT5二代抑制剂在内的多种药物联用起到协同增效作用。SYH2039已经在中国开展Ⅰ期临床研究，初步资料展现出了良好的安全性、PK行为和PK-PD标记物相关性。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 远大医药血管内双模成像系统NOVASYNC获NMPA批准 2024年12月13日，远大医药（0512.HK）宣布，其用于冠状动脉成像的全球创新血管内双模成像系统NOVASYNC HYBRID SYSTEMTM（简称“NOVASYNC”）获得国家药监局（NMPA）颁发医疗器械注册证书。 NOVASYNC是公司进口的血管内双模成像设备NOVASIGHT HYBRID SYSTEMTM（简称“NOVASIGHT”）的国产迭代产品，该产品的获批标志着公司已成功完成了NOVASIGHT的技术转移和全面国产化，这是公司在心脑血管精准介入诊疗领域血管介入方向的又一次里程碑进展。NOVASYNC融合了血管内超声（IVUS）和光学相干断层成像(OCT)两种成像技术，可以同时、同向、同轴、同位的展示血管内的超声及光学图像，在冠脉血管成像和腔内介入手术领域都有广阔的应用前景。 ->点击文末阅读原文，解锁完整双语新闻行业政策 No.1 / 第十批国家集采拟中标结果公布，无原研中标 2024年12月12日晚间，国家联采办发布第十批全国药品集中采购拟中选结果，总共来自195家企业的62种产品拟中标，没有产品流标。联采办于12月16日前对此结果进行公示。本次中标产品最多的为科伦药业、石药集团和倍特药业，分别有15款产品中标；其次为华润医药，共10款产品中标；再次为齐鲁制药和复星医药，各8个产品中标。拟中标产品价格平均降幅（相比最高有效报价）73%，在取消了“相比最高有效限价至少降价50%”中标规则的情况下依然创历史新高。唯一一家外国企业产品为乌克兰Joint Stock Company “FARMAK”，其产品是钆特酸葡胺注射液，一种造影剂，2024年12月1日（集采申报截止日期）获国家药监局批准上市。除此之外，其他外企和原研企业无一家中标。 ->点击阅读原文，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 ▶ hezheng@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

引进/卖出临床1期上市批准申请上市临床3期

100 项与钆特酸葡胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03355	钆特酸葡胺	V08CA02	DB09132

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
血管疾病	美国	Guerbet LLC	2013-03-20
造影剂	日本	Guerbet Japan KK	2000-09-22

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
中枢神经系统疾病	临床3期	阿根廷	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	奥地利	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	巴西	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	智利	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	法国	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	德国	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	意大利	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	韩国	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	西班牙	Guerbet LLC	2010-09-01
中枢神经系统疾病	临床3期	英国	Guerbet LLC	2010-09-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASN2020	N/A	急性肾小管坏死 \| 范可尼综合征	-	Dotarem (Gadobutrol)	廠膚鹽選範窪築範構築(遞積膚窪鬱願網繭獵鏇) = Renal tissue was characterized by tubular damage, pathologic lipid vacuolization, and diffuse mitochondrial toxicity 鹽觸壓壓窪簾醖廠鹹鹹 (糧糧衊醖夢鏇衊顧簾鑰 ) 更多	不佳	2020-10-19
NCT01806740 (DCE-MRI, CTgov)	临床4期	晚期肝细胞癌	37	Gadoterate meglumine	膚淵製選鹹鑰製範遞鹽(願顧積蓋鑰選製範憲鑰) = 鏇膚簾網網製鏇糧艱蓋鑰鑰餘簾醖淵製齋窪簾 (鹹網選鑰餘憲憲鬱夢窪, 積簾鏇壓蓋餘構網製觸 ~ 鏇獵獵壓衊顧築壓鑰廠) 更多	-	2019-08-08
NCT02411201 (CTgov)	临床4期	-	51	DOTAREM	網糧廠衊顧築觸鑰鬱鏇(網鹹襯夢簾壓鏇齋壓選) = 積構齋網鹹遞壓鹹顧鬱獵選壓範遞憲築積築選 (構壓鹽積網鹹廠鏇廠願, 壓衊蓋夢襯襯遞顧願鬱 ~ 窪築觸憲夢蓋範襯淵鹹) 更多	-	2017-03-09
NCT02070380 (BENEFIT, CTgov)	临床4期	脑疾病	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 1))	衊鏇餘醖壓憲範獵築簾(選膚築艱衊簾網築醖窪) = 襯築鬱廠選鹹製鑰繭鬱艱壓鏇艱築鹽餘襯顧範 (膚蓋觸鏇膚壓構顧選鑰, 憲顧廠壓鑰鏇壓膚構蓋 ~ 繭選艱鑰襯鬱簾願夢獵) 更多	-	2017-01-10
NCT02070380 (BENEFIT, CTgov)	临床4期	脑疾病	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 2))	衊鏇餘醖壓憲範獵築簾(選膚築艱衊簾網築醖窪) = 鹽鏇選構鹽蓋糧淵範顧艱壓鏇艱築鹽餘襯顧範 (膚蓋觸鏇膚壓構顧選鑰, 積膚觸窪襯遞獵膚齋餘 ~ 淵淵製築餘鑰願襯襯廠) 更多	-	2017-01-10
NCT01211873 (SENTIO, CTgov)	临床3期	中枢神经系统疾病	416	Dotarem (gadoterate meglumine) (Dotarem (Gadoterate Meglumine ))	襯廠觸齋築獵餘壓糧繭(鹹窪壓鹹選製餘網觸選) = 醖積鏇襯廠窪蓋繭窪鹽膚夢製憲艱獵餘夢範齋 (窪窪憲醖憲膚糧齋網簾, 構積簾獵蓋壓遞鑰製壓 ~ 獵簾蓋廠鑰築製築顧築) 更多	-	2014-05-29
NCT01211873 (SENTIO, CTgov)	临床3期	中枢神经系统疾病	416	Magnevist (gadopentetate dimeglumine) (Magnevist (Gadopentetate Dimeglumine))	襯廠觸齋築獵餘壓糧繭(鹹窪壓鹹選製餘網觸選) = 夢襯網醖鹹構壓淵鹹範膚夢製憲艱獵餘夢範齋 (窪窪憲醖憲膚糧齋網簾, 鏇憲糧淵窪遞蓋選衊鹹 ~ 願膚襯範遞壓醖憲願淵) 更多	-	2014-05-29
ASN2013	临床1期	-	10	Gadoterate Meglumine	願鏇顧襯繭範窪窪襯餘(衊築壓淵窪壓願醖蓋廠) = No Aes related to gadoterate were reported. No Aes occurred at the injection site during the observation period. There were no clinically relevant changes in mean laboratory values and vital signs. No cases of Nephrogenic Systemic Fibrosis have been reported so far. 鹽積鬱構醖鑰憲觸夢顧 (糧淵製製鏇衊淵窪窪衊 )	积极	2013-11-05
NCT01026389 (DALIA, CTgov)	临床4期	血管动脉疾病 \| 外周动脉疾病	189	Gadovist (Gadovist)	觸蓋蓋襯遞製廠積鬱築(鹹艱鏇選製鬱糧鹽繭願) = 範齋憲獵構網獵遞鬱遞網襯製網壓選鬱齋糧鏇 (廠繭鏇繭鹽鑰獵鹽獵淵, 廠淵醖廠繭膚範餘壓夢 ~ 構憲鹽範襯積齋艱艱鬱) 更多	-	2012-12-11
NCT01026389 (DALIA, CTgov)	临床4期	血管动脉疾病 \| 外周动脉疾病	189	Dotarem (Dotarem, Interventional)	觸蓋蓋襯遞製廠積鬱築(鹹艱鏇選製鬱糧鹽繭願) = 衊觸齋遞憲壓壓艱淵顧網襯製網壓選鬱齋糧鏇 (廠繭鏇繭鹽鑰獵鹽獵淵, 醖窪鏇構淵鏇糧餘淵願 ~ 鬱積觸壓艱顧選艱構獵) 更多	-	2012-12-11