A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT05915702 / Completed临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT04910425 / Not yet recruiting临床2期IIT

Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

开始日期2023-06-17

申办/合作机构

Northwestern University

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100 项与钆布醇相关的临床结果

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100 项与钆布醇相关的转化医学

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100 项与钆布醇相关的专利（医药）

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757

项与钆布醇相关的文献（医药）

2024-12-01·Investigative Radiology

Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol

Article

作者: Kahn, Johannes F ; Klemens, Mark A ; Ebert, Wolfgang ; Berse, Matthias ; Riecke, Kai ; Klein, Stefan ; Hofmann, Birte M ; Palkowitsch, Petra ; Posch, Helena

ObjectivesTo investigate the signal-enhancement properties of the tetrameric gadolinium-based contrast agent (GBCA) gadoquatrane in relation to the administered dose and compare its properties to those of a standard dose of gadobutrol, as a representative of the currently established macrocyclic GBCAs for magnetic resonance imaging.Materials and MethodsIn this randomized, single-blind, 4 × 4 crossover study, 43 healthy adults (19–50 years of age) received 3 single IV injections of gadoquatrane (0.01, 0.03, and 0.06 mmol gadolinium/kg body weight) and 1 injection of gadobutrol (0.1 mmol gadolinium/kg body weight) in randomized sequence with 1-week washout periods between administrations. The relative signal enhancement (RSE) was determined in predefined areas of interest in magnetic resonance image sets of the head-neck region. RSE-vs-dose curves (dose-response curves) were established by linear regression, and comparator-equivalent doses were determined by Bayesian inverse regression analysis. Further, 3 blood samples were taken after each injection for pharmacokinetic analyses, and safety data were assessed.ResultsThe RSE increased with gadoquatrane dose. A linear function adequately fitted this relationship. In line with the more than 2-fold higher r1 relaxivity of gadoquatrane per gadolinium ion, gadobutrol-equivalent RSE was achieved with gadoquatrane at less than half the gadolinium dose and less than one eighth of the molecule dose.Administration of gadoquatrane and gadobutrol resulted in very similar dose-normalized gadolinium concentrations in plasma, indicating that the pharmacokinetic profiles are essentially the same. Both contrast agents were well tolerated. Adverse events were rare and not dependent on the dose administered.ConclusionsGadoquatrane has the potential to be an effective GBCA that can be used at substantially lower doses in clinical routine than the currently established macrocyclic GBCAs.

2024-12-01·NMR in Biomedicine

Characterizing diffusion‐controlled release of small‐molecules using quantitative MRI in view of applications to orthopedic infection

Article

作者: Drangova, Maria ; Khazaee, Tina ; Christiansen, Spencer D. ; Cobos, Santiago F. ; Liu, Junmin ; Holdsworth, David W. ; Hong, Greg

AbstractCalcium sulfate is an established carrier for localized drug delivery, but a means to non‐invasively measure drug release, which would improve our understanding of localized delivery, remains an unmet need. We aim to quantitatively estimate the diffusion‐controlled release of small molecules loaded into a calcium sulfate carrier through a gadobutrol‐based contrast agent, which acts as a surrogate small molecule. A central cylindrical core made of calcium sulfate, either alone or within a metal scaffold, is loaded with contrast agents that release into agar. Multi‐echo scans are acquired at multiple time points over 4 weeks and processed into R2* and quantitative susceptibility mapping (QSM) maps. Mean R2* values are fit to a known drug delivery model, which are then compared with the decrease in core QSM. Fitting R2* measurements of calcium sulfate core while constraining constants to a drug release model results in an R2‐value of 0.991, yielding a diffusion constant of 4.59 × 10−11 m2 s−1. Incorporating the carrier within a metal scaffold results in a slower release. QSM shows the resulting loss of susceptibility in the non‐metal core but is unreliable around metal. R2* characterizes the released gadobutrol, and QSM detects the resulting decrease in core susceptibility. The addition of a porous metal scaffold slows the release of gadobutrol, as expected.

2024-10-24·Journal of Medicinal Chemistry

Construction of New MRI Contrast Agents for Spatiotemporal Visualization of Nitric Oxide in Ischemia/Reperfusion Organs

Article

作者: Yan, Zhengsheng ; Xu, Anning ; Zhang, Libang ; Sun, Yuze ; Wu, Jianbing ; Gao, Zonglu ; Yuan, Xun ; Huang, Zhangjian ; Yin, Zhiqi ; Zhang, Yihua ; Wang, Lin ; Zhang, Jian ; Jing, Mei

Noninvasive and real-time nitric oxide (NO) visualization in vivo is still a challenge. Herein, we constructed a series of NO-responsive magnetic resonance imaging (MRI) contrast agents Gd1b-e by modifying Gd-DO3A using a bis-pyridyl-ethylamine side chain as a signal-amplifying moiety and o-phenylenediamine as a NO-responsive linker. It was found that Gd1b, d, and e can form macromolecular ternary complexes (Gd-Zn²⁺-HSA) with high longitudinal relaxivity (r₁) (12.2-16.2 mM^-1 s^-1). Once reacting with NO, the o-phenylenediamine linker was hydrolyzed to produce a small molecular Gd complex with sharply decreased r₁ (4.7-6.3 mM^-1 s^-1). Among them, Gd1d with a desirable pharmacokinetic profile (t_1/2 = 5.91 h) could clearly distinguish the ischemia-reperfusion (IR) liver with excessive NO in rats. Meanwhile, the temporarily reduced amount of NO in the IR liver and brain by the NO scavenger 2-phenyl-4,4,5,5-tetramethylimidazoline-3-oxide-1-oxyl could enhance the signal of Gd1d, suggesting anticipated NO-responsive property. This research offers a new avenue for insight into the NO spatiotemporal property in multiple IR organs.

129

项与钆布醇相关的新闻（医药）

2024-11-19

·普利制药300630

【喜讯】安徽普利原料药硝普钠荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！

【喜讯】安徽普利原料药硝普钠荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！海南普利制药股份有限公司（以下简称“普利制药”）控股子公司安徽普利药业有限公司（以下简称“安徽普利”）已于近日收到欧洲药品质量管理局（European Directorate for the Quality of Medicines & HealthCare，已下简称“EDQM”）签发的原料药硝普钠欧洲药典适用性认证（以下简称“CEP”）证书。本次硝普钠CEP证书的获得，表明该原料药符合欧洲药典的质量要求，显示欧洲规范市场对该原料药质量的认可和肯定。为安徽普利进一步拓展国际市场带来积极影响。 1、硝普钠产品基本情况 1、产品基本情况介绍硝普钠注射液是一种血管扩张剂，主要用于： ①用于高血压急症，如高血压危象、高血压脑病、恶性高血压、嗜铬细胞瘤手术前后阵发性高血压等的紧急降压，也可用于外科麻醉期间进行控制性降压。 ②用于急性心力衰竭，包括急性肺水肿。亦用于急性心肌梗死或瓣膜（二尖瓣或主动脉瓣）关闭不全时的急性心力衰竭。 2、市场情况根据IMS显示，从2018年至2022年，硝普钠注射剂全球出厂销售额呈现平稳增长，2022年突破5343万美国的市场需求， 2022年全球市场体量达到335kg规模。 3、质量优势 1）产品质量优于参比制剂； 2）符合ChP、EP、USP质量标准； 3）有专用生产线，可以稳定供货; 4) 生产自动化程度高，在保证供货的前提下，产品质量更有保障。 4、注册法规优势安徽普利硝普钠产品已在中美等市场进行原料药备案/登记，高品质原料药满足各级市场注册、生产、销售需求。 ①其中US DMF号为039947（状态：A ）; ②CN登记号为Y20240001218 (状态: I ）； ③CEP证书号：CEP 2024-357- Rev 00 ,符合欧洲药典的质量要求；其他市场的注册工作也在持续推进中。同时，海南普利硝普钠原料药在美国、欧盟，中国有文号并激活，高品质原料药满足各级市场注册、生产、销售需求。 ①其中US DMF号为033023（状态：A ）; ②CN登记号为Y20190000020 (状态: A ）； ③CEP证书号：R0-CEP 2020-114 - Rev 01 ，符合欧洲药典的质量要求。 2、中国首家过评，首家水针剂型水针获全球认可，粉针遭主流市场淘汰硝普钠最早由美国罗氏公司在1974年FDA审批上市，上市剂型为粉针剂。在积累了十余年的硝普钠临床用药经验后，为了弥补硝普钠的临床配液使用缺陷，HOSPIRA公司对硝普钠剂型进行改良升级，研发出硝普钠水针剂型，并于1988年成功获批上市。随后美国的多家药企均以硝普钠水针剂型进行上市申报并陆续获批，并因其临床使用较粉针剂更为安全、便捷而得到更加广泛的临床认可，因此在美国硝普钠粉针剂型迅速退出历史舞台，从上世纪90年代开始粉针剂型陆续停产，到21世纪初，美国的硝普钠粉针剂已经全面停产下线，市场完全被水针剂替代。除此之外，在法国、日本等国际主流市场，目前上市剂型也全为水针剂型。中国权威认可水针，粉针剂无参比制剂参考上述，硝普钠各剂型经过上述国际主流市场的市场考验，在中国国家药品监督管理局药品审评中心（CDE）发布的仿制药参比制剂目录中，硝普钠注射剂的参比制剂均为水针剂型，说明硝普钠粉针剂型在中国并未得到官方认可。普利保欣®国内首家过评，首家水针剂型，长线品种正因为CDE参比制剂目录中没有硝普钠粉针剂，所以中国市场上市的所有硝普钠粉针剂均无法通过仿制药一致性评价。目前普利保欣®硝普钠注射液是国内首家过评，首家水针剂型。目前仅有2家硝普钠注射批文，较长时间不会参加国家集采，属于长线品种。 3、合作共赢安徽普利将利用自身产品优势，发挥国际注册的能力（已经在多国注册，并且有丰富的国际注册经验），借助国际化制造、质量控制体系和成熟的国际化市场开拓能力，愿与有志于开拓此产品的国内、国际制剂客户提供全方位、深度合作，共创未来。安徽普利安徽普利药业有限公司坐落于安庆国家高新技术产业开发区。是一家活性原料专业供应商，向全球医药、保健和护肤领域提供化学合成、生物合成的高品质特色原料。安徽普利目前拥有10条符合欧美中GMP标准的API 生产线，357台多功能设备。依托强大的研发能力和技术转化能力，已完成造影剂（钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等）、合成生物学（司美格鲁肽、熊去氧胆酸、依克多因、红景天苷等）、抗肿瘤（BPA、环磷酰胺等）、其他原料药（盐酸多巴酚丁胺、硝普钠、氢氧化镁、阿普斯特、克立硼罗、伏立康唑、格隆溴铵、盐酸美金刚、特考韦瑞、阿昔洛韦钠、更昔洛韦钠、布美他尼、氟康唑、二硫化硒、别嘌醇等）、其他药用辅料（DOTA、SNAC、磺丁基-β-环糊精钠、卡特利多钙、考布曲钙钠等）等系列产品的研发与生产。欢迎垂询、欢迎合作！ Welcome for enquiry, cooperation！联系人：聂先生 Liangdeng Nie 电话：18857693467 邮箱：nieliangdeng@hnpoly.com 联系人：薛女士 Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com

申请上市上市批准

2024-11-18

·普利制药300630

【喜讯】安徽普利原料药钆布醇荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！

【喜讯】安徽普利原料药钆布醇荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！海南普利制药股份有限公司（以下简称“普利制药”）控股子公司安徽普利药业有限公司（以下简称“安徽普利”）已于近日收到欧洲药品质量管理局（European Directorate for the Quality of Medicines & HealthCare，已下简称“EDQM”）签发的原料药钆布醇欧洲药典适用性认证（以下简称“CEP”）证书。本次钆布醇CEP证书的获得，表明该原料药符合欧洲药典的质量要求，显示欧洲规范市场对该原料药质量的认可和肯定。为安徽普利进一步拓展国际市场带来积极影响。并且车间于2023年通过FDA现场检查，药品生产符合美国 FDA的cGMP要求，未来产品将稳定且持续服务于全球客户。 1、钆布醇产品基本情况 1、产品基本情况介绍钆对比剂是最常见的顺磁性对比剂，通过静脉注射引入人体。注射对比剂进行增强扫描后，图像能更加清晰地显示病变边缘或临近组织、内部结构、血供等情况，从而利于病灶检出，帮助疾病诊断。据统计，自从钆对比剂首次被批准用于人类临床诊疗以来，钆对比剂在磁共振检查数量中的应用率高达35%，全世界已进行了4亿多次钆对比剂注射。钆布醇是一种兼具高浓度和高弛豫率的大环状非离子型钆对比剂，显影更清晰，并且集合了对比增强成像的有效性和安全性，适用于全身全年龄段（包括足月新生儿）检查，包括肾功能不全患者。 2、市场情况根据IMS显示，除2020年受全球公共卫生事件影响，不可抗力导致的略微下降外，从2018年至2023年，钆布醇注射剂全球出厂销售额呈现平稳增长，2023年突破4亿美国的市场需求。全球原料药消耗量也呈平稳增长，2023年市场体量达到72吨规模。同比增长率较销售额更高，体现市场对原料药的需求量增长更快。 2023年全球制剂市场占比来看，以欧美市场为主，销售额前五分别为美国、法国、日本、土耳其、意大利，合计占比约57%。 2023年全球原料药消耗量来看，市场消耗前五是美国、土耳其、中国、波兰、德国，合计65%，安徽普利钆布醇原料药已获得美国、土耳其、中国、波兰、德国等主要市场的进入资格。 3、质量优势 1）可同时符合中、美、欧等多方药典标准；产品质量优于参比制剂，无机盐均严格控制，氯离子100ppm以下，锂离子25 ppm以下； 2）钆布醇API为稳定晶型，稳定性更优； 3）有专用生产线，产线自动化程度高，保证稳定供货，年产能可达到20吨以上； 4）可同时提供注射剂辅料考布曲钙钠； 5）钆造影剂生产线车间已通过美国FDA现场检查，符合美国FDA的cGMP要求。 4、注册法规优势本品已在中美等市场进行原料药备案/登记， ①其中US DMF号为039149（状态：A ）; ②CN登记号为Y20240000083，(状态: I ）； ③CEP证书号：CEP 2024-082- Rev 00 ,符合欧洲药典的质量要求； ④获得WC证明，获得土耳其市场的入场资格；其他市场的注册工作也在持续推进中。 2、合作共赢安徽普利将利用自身产品优势，发挥国际注册的能力（已经在多国注册，并且有丰富的国际注册经验），借助国际化制造、质量控制体系和成熟的国际化市场开拓能力，愿与有志于开拓此产品的国内、国际制剂客户提供全方位、深度合作，共创未来。安徽普利安徽普利药业有限公司坐落于安庆国家高新技术产业开发区。是一家活性原料专业供应商，向全球医药、保健和护肤领域提供化学合成、生物合成的高品质特色原料。安徽普利目前拥有11条符合欧美中GMP标准的API 生产线，357台多功能设备。依托强大的研发能力和技术转化能力，已完成造影剂（钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等）、合成生物学（司美格鲁肽、熊去氧胆酸、依克多因、红景天苷等）、抗肿瘤（BPA、环磷酰胺等）、其他原料药（盐酸多巴酚丁胺、硝普钠、氢氧化镁、阿普斯特、克立硼罗、伏立康唑、格隆溴铵、盐酸美金刚、特考韦瑞、阿昔洛韦钠、更昔洛韦钠、布美他尼、氟康唑、二硫化硒、别嘌醇等）、其他药用辅料（DOTA、SNAC、磺丁基-β-环糊精钠、卡特利多钙、考布曲钙钠等）等系列产品的研发与生产。欢迎垂询、欢迎合作！ Welcome for enquiry, cooperation！联系人：聂先生 Liangdeng Nie 电话：18857693467 邮箱：nieliangdeng@hnpoly.com 联系人：薛女士 Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com

医药出海诊断试剂申请上市

2024-10-29

·北陆药业

北陆药业前三季度营收稳健增长，净利润同比涨11倍！

近日，北陆药业（300016）发布《2024年第三季度报告》。2024年前三季度，公司继续稳健经营，实现营业收入7.30亿元，同比增长12.30%；归属于上市公司股东的净利润为2,439.43万元，同比增长1156.34%；归属于上市公司股东的扣除非经常性损益的净利润为2,521.87万元，同比增长275.59%。在“二次创业”理念的引领下，公司积极践行“化药+中药”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。营业收入稳定增长公司基本盘稳固 2024年第三季度，北陆药业营业收入为2.56亿元，较上年同期增长20.77%，在此影响下，前三季度营业收入为7.30亿元，较上年同期增长12.30%。公司继续推动纳入集采的对比剂产品及降糖类产品的集采执标工作，并积极推广其他未纳入集采的产品销售，同时海外市场业务进展顺利，公司营业收入持续稳定增长。盈利能力强力回升战略转型初现成效相对于营业收入的稳定增长，公司净利润等相关指标的改善更加显著。2024年前三季度，北陆药业的归母净利润、扣非后的归母净利润分别为2,439.43万元、2,521.87万元，较上年同期分别增长1156.34%和275.59%。公司的盈利能力逐步恢复，公司经营回归良性运作，公司的战略转型初现成效。推动并购重组加大中成药板块布局公司一直重视“并购重组”业务，今年已通过并购的方式收购承德天原药业80%的股权，并将其纳入公司合并范围。公司目前拥有59个中成药产品，北陆药业的九味镇心颗粒和天原药业的金莲花颗粒作为公司两大销售额过亿的“黄金单品”，不仅具有良好的市场竞争力，同时为公司打造中药品牌提供了极强的助力。随着公司对天原药业的整合与赋能，公司的中药板块将成为公司业绩持续增长的重要驱动力，有望成为公司的“第二增长曲线”。积极提升研发效率研发成果逐渐落地报告期内，公司继续调整研发组织架构，提高研发效率，在对比剂制剂及原料药、中枢神经、内分泌、消化、维生素、外用制剂等领域布局，研发立项更加多元。全资子公司艾湃克斯积极落实公司的各项研发任务，并取得了阶段性的进展。年初至今，公司钆布醇注射液（15ml:9.0708g）、盐酸帕罗西汀肠溶缓释片、钆特酸葡胺注射液及原料药、硫酸钠等获批上市。钆贝葡胺注射液（10ml : 5.290g）、钆喷酸葡胺注射液（10ml：4.69g、12ml：5.63g）通过仿制药质量和疗效一致性评价。控股子公司海昌药业碘克沙醇化学原料药获批上市，生产车间通过 GMP 符合性检查。丰富的产品储备让公司未来经营业绩有了更多的增长可能性。

上市批准一致性评价并购财报

100 项与钆布醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07420	钆布醇	V08CA09	DB06703

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
冠心病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-12
主动脉疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2016-04-27
乳腺疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2014-12-29
中枢神经系统血管畸形	美国	Bayer HealthCare Pharmaceuticals, Inc.	2011-03-14
脑血管疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2011-03-14
造影剂	澳大利亚	Bayer Australia Ltd.	1998-12-02

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
诊断试剂	药物发现	美国	Bayer AG	2008-06-01
诊断试剂	药物发现	哥伦比亚	Bayer AG	2008-06-01
诊断试剂	药物发现	印度	Bayer AG	2008-06-01
诊断试剂	药物发现	德国	Bayer AG	2008-06-01
诊断试剂	药物发现	澳大利亚	Bayer AG	2008-06-01
诊断试剂	药物发现	瑞士	Bayer AG	2008-06-01
诊断试剂	药物发现	日本	Bayer AG	2008-06-01
中枢神经系统疾病	药物发现	哥伦比亚	Bayer AG	2007-12-01
脑转移瘤	药物发现	日本	Bayer AG	2007-08-01
脊柱疾病	药物发现	中国	Bayer AG	2006-09-01

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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


NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	網淵網鏇窪淵獵繭窪繭(壓窪醖獵夢膚糧網窪憲) = 觸觸網艱餘膚範製襯鹽繭糧遞淵築醖齋廠構選 (衊淵襯艱夢憲夢選鹹選, 範窪膚鏇窪窪壓積願夢 ~ 廠鏇鏇鹹範鑰醖齋繭築) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	網淵網鏇窪淵獵繭窪繭(壓窪醖獵夢膚糧網窪憲) = 選醖鏇構繭製壓積蓋夢繭糧遞淵築醖齋廠構選 (衊淵襯艱夢憲夢選鹹選, 糧廠衊顧夢積獵顧簾淵 ~ 衊襯鑰觸夢醖積願憲鏇) 更多	-	2021-04-28
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) 人工标引	临床3期	造影剂	560	Gadopiclenol+gadobutrol	(艱鬱願選襯顧觸壓襯襯) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. 遞觸製壓夢繭選鏇襯繭 (膚鏇獵鬱壓遞繭淵鏇淵 ) 更多	积极	2021-03-24
	临床3期	造影剂	560	Gadobutrol+Gadopiclenol		积极	2021-03-24
NCT03404648 (CTgov)	临床3期	晚期前列腺癌 \| 前列腺腺癌	19	PET/MR scanner+C-11 choline PET tracer+Gadobutrol	膚構鏇齋蓋襯膚遞壓鏇(淵淵餘衊觸衊壓窪繭蓋) = 壓簾蓋選積鹽願糧構鹽艱遞蓋網餘淵選築憲窪 (窪範選窪鹹艱艱衊築願, 襯簾觸鏇鹽築艱鹽廠觸 ~ 衊鹽積構壓餘窪願積壓) 更多	-	2021-02-08
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	簾獵蓋觸範廠襯襯鏇鬱(選鑰鏇鹹鏇糧齋築製鏇) = 範壓衊簾衊遞夢顧糧構範夢膚簾鑰蓋齋顧網壓 (夢獵齋齋獵膚壓窪廠糧, 構鬱壓淵觸艱鏇淵壓鬱 ~ 選鑰鑰憲廠醖鏇築壓鬱) 更多	-	2018-05-16
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadobutrol (Gadovist, Gadavist, BAY86-4875)	壓膚築襯遞鬱糧築繭憲(衊糧憲鹹願選糧糧艱膚) = 鏇願憲顧構淵簾觸繭齋選鹽壓範窪衊蓋壓積顧 (鏇願構選鹽獵繭蓋醖鬱, 窪壓積構憲選簾淵膚觸 ~ 鏇鏇積壓構獵構獵糧衊) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	(網觸齋鏇網積願壓壓顧) = 艱選蓋繭觸積醖鏇淵蓋壓淵艱夢願壓衊淵鑰鹹 (繭鏇築顧遞製鹹獵選膚 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	餘醖網襯廠遞憲廠範鏇(蓋衊簾廠夢範範齋膚構) = the detection rate of malignant disease extent per patient, ranged from 80% to 89% for CE-BMRI and was significantly superior to unenhanced breast MRI alone (37%-73%) and to mammography alone (68%-73%) for all readers in both trials. 繭醖齋願鏇積膚夢網壓 (鹽積構網網廠夢淵襯夢 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	簾獵餘構選鬱廠糧觸壓(憲壓觸淵壓選遞膚窪蓋) = 獵鑰憲蓋壓範膚簾獵壓築製鏇襯獵積鑰網積衊 (鬱遞膚遞壓選願願餘選 ) 更多	积极	2016-04-29
NCT01490294 (CTgov)	临床2期	心肌缺血	232	Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	憲鬱壓鑰積襯網繭襯壓(襯築繭顧積範製鏇製齋) = 築衊顧壓簾醖憲鏇鏇願簾艱網鏇範夢製觸廠鑰 (築衊齋網積糧願憲觸糧, 積構鹹廠鏇衊繭齋製築 ~ 網夢艱糧蓋蓋醖範觸齋) 更多	-	2012-06-28
NCT01490294 (CTgov)	临床2期	心肌缺血	232	Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	憲鬱壓鑰積襯網繭襯壓(襯築繭顧積範製鏇製齋) = 窪鏇鑰憲襯遞窪簾遞鹹簾艱網鏇範夢製觸廠鑰 (築衊齋網積糧願憲觸糧, 襯憲壓鹹膚製選醖襯窪 ~ 淵糧壓餘遞蓋顧遞衊選) 更多	-	2012-06-28
NCT00468819 (CTgov)	临床1期	-	140	Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years)	淵選積廠鹽觸範顧積顧(網壓醖壓遞壓選獵壓壓) = 顧構廠網壓網廠鑰膚顧醖糧鬱艱夢壓襯繭獵齋 (製餘蓋願選蓋齋憲積顧, 鏇簾艱壓糧顧廠窪鏇顧 ~ 製鹹遞鏇鑰願膚鹹鹽鹹) 更多	-	2011-09-05
NCT00468819 (CTgov)	临床1期	-	140	Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years)	淵選積廠鹽觸範顧積顧(網壓醖壓遞壓選獵壓壓) = 製簾蓋願鬱簾鑰鬱蓋築醖糧鬱艱夢壓襯繭獵齋 (製餘蓋願選蓋齋憲積顧, 網觸鑰網夢繭網餘顧網 ~ 顧選衊鏇憲夢夢網艱構) 更多	-	2011-09-05