This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

开始日期2025-06-27

申办/合作机构

The Brigham & Women's Hospital, Inc.

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

NCT05915728

/ 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 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

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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806

项与钆布醇相关的文献（医药）

2025-10-01·EUROPEAN JOURNAL OF RADIOLOGY

Gadolinium concentration dependent signal enhancement profiles using routine clinical sequences with gadopiclenol, gadoterate, gadobutrol, and gadoxetate at 1.5, 3 and 7 Tesla

Article

作者: Froehlich, Johannes M ; Nanz, Daniel ; Sutter, Reto ; Marth, Thomas

PURPOSE:

Gadopiclenol, a new gadolinium-(Gd) based contrast agent (GBCA), exhibits a higher longitudinal relaxivity (r₁) than current standard GBCAs, and, thus, has the potential to be used at lower dose or to generate a brighter T1-weighted (T1w) signal at equivalent dose. As the relationship between enhancement and contrast agent concentration is non-linear, the signal profiles should be experimentally explored and compared to those of current GBCAs.

MATERIALS AND METHODS:

Standardized aqueous dilution series (0.0 to 25 mmol/L) of gadopiclenol, and current standard GBCAs gadoterate, gadobutrol, and gadoxetate were imaged with nine clinical sequences at 1.5, 3, and 7 Tesla(T). Signal intensities(SIs) were measured for each concentration and set in relation to the SI of water(rSI). Additionally, T1 relaxation times were measured at 3 T and r₁ was calculated.

RESULTS:

The maximum rSI in T1w fast-spin-echo images was observed at a lower Gd concentration (1.0 mmol/L) at all three field strengths in the gadopiclenol series than in the current standard GBCAs series (gadoterate and gadobutrol, 2.5 mmol/L, all field strengths, gadoxetate, 2.5 mmol/L at 1.5 and 3 T, 1.0 and 2.5 mmol/L at 7 T). The maximum rSI measured at 1.0 mmol/l gadopiclenol was comparable (±12 %rSI) to the rSI at 2.5 mmol/l of standard GBCAs. Molar gadopiclenol relaxivity, r₁, (13.5 ± 1.5 s^-1∙mM^-1) was three to four times higher than r₁ of gadoterate and gadobutrol (3.4 ± 0.4 and 4.1 ± 0.5 s^-1∙mM^-1, respectively), and 2.2 times higher than of that of gadoxetate (6.0 ± 0.7 s^-1∙mM^-1).

CONCLUSION:

Our results confirm the maximum signal intensity in clinical T1w images to be shifted to lower gadolinium concentrations of gadopiclenol compared to standard GBCAs at all field strengths.

2025-09-01·STROKE

Investigation of Poststroke Depression Following a Nucleus Accumbens Infarct in Mice

Article

作者: Collignon, Adeline ; Ménard, Caroline ; Dion-Albert, Laurence ; Daigle, Béatrice ; Lévesque, Martin ; Desjardins, Michèle ; St-Arnault, Vincent ; Rioux, Véronique ; Menegatti Bevilacqua, Laura ; Bandeira Binder, Luisa ; Lebel, Manon ; Bouchard, Jonathan

BACKGROUND::

Poststroke depression (PSD) affects ≈33% of individuals 1 year after a stroke. Blood-brain barrier (BBB) dysfunction in the nucleus accumbens (NAc), a hub for emotional processing, reward, and mood regulation, has been linked to stress-induced depressive-like behaviors in male mice. Neurovascular alterations were also observed in postmortem tissue samples from men with a diagnosis of major depression. Thus, we aimed to investigate if BBB changes in the NAc could contribute to PSD pathophysiology.

METHODS::

Stereotaxic injection of ET-1 (endothelin-1), a potent vasoconstrictor, was performed in the NAc of male mice to create a focal brain stroke, and then, infarct size and localization were assessed and quantified. We subsequently evaluated transcriptomic and morphological effects of the infarct on BBB-related genes and cells in the NAc, particularly those known to be altered after stress exposure in mice or human depression. BBB integrity was assessed with a dextran dye, and magnetic resonance imaging scans were conducted before versus after the injection of Gadovist, a contrast agent. Last, a battery of behavioral tests related to depressive- and anxiety-like behaviors was performed to determine if an infarct in the NAc is sufficient to induce a PSD-like phenotype.

RESULTS::

Following ET-1 injection, ≈50% of the total lesion was observed in the NAc leading to BBB hyperpermeability in this brain area. BBB gene expression was impacted by ET-1, and also surgery alone and profiles were differentially regulated throughout time up to 14 days. Gliosis in the NAc was observed with increased reactivity of astrocytes and microglia. The effect of ET-1 on PSD-like symptoms was limited. However, body weight, sociability, and activity were affected by surgery with a more pronounced impact of ET-1 on social interactions compared with naive animals.

CONCLUSIONS::

While no clear PSD phenotype was observed following an ET-1–induced stroke in the NAc of male mice, our study shed light on the technical complexity of focal lesions in deep brain structures, an understudied phenomenon occurring in humans. We provide technical insights for the development of a mouse model of deep brain lesions, characterize its impact at molecular, cellular, and behavioral levels, and highlight the need to control for vascular alterations when performing stroke surgeries.

2025-08-13·MAGNETIC RESONANCE IN MEDICINE

Dynamic contrast enhanced-magnetic resonance fingerprinting (DCE-MRF): A new quantitative MRI method to reliably assess tumor vascular perfusion.

Article

作者: Dhakan, Chetan B ; Wu, Chunying ; Flask, Chris A ; Yu, Xin ; Schiemann, William P ; Pagel, Mark D ; Griswold, Mark A ; Dupuis, Andrew ; Zhu, Yuran ; Wang, Guanhua ; Kavran, Michael ; MacAskill, Christina J ; Erokwu, Bernadette O ; Schiemann, Barbara J

PURPOSE:

The clinical utility of conventional DCE-MRI methods is limited by the use of conventional qualitative dynamic T₁-weighted images, resulting in poor reproducibility. This study presents the initial implementation of a new DCE-magnetic resonance fingerprinting (DCE-MRF) methodology to provide reproducible, quantitative assessments of tumor vascular perfusion.

METHODS:

The DCE-MRF acquisition combines multiple T₁ preparations, highly undersampled spiral trajectories (R = 48), a low-rank reconstruction method, and low tip angles on a 9.4 T preclinical MRI scanner to rapidly generate dynamic T₁ maps (23-s temporal resolution). In vitro validation experiments were conducted across a range of Gadovist concentrations to assess accuracy and temporal precision in comparison to conventional methods. The DCE-MRF method was also evaluated in vivo in an orthotopic 4T1 mouse model of breast cancer (n = 25). Pharmacokinetic modeling of the in vivo data was performed using a linear reference region model (LRRM).

RESULTS:

In vitro DCE-MRF studies demonstrated good agreement with conventional MRI methods for T₁ measurements (R² __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ ≥ $$ \ge $$ 0.99). The iterative low-rank reconstruction method also reduced artifacts compared to conventional reconstruction methods. DCE-MRF demonstrated a 2- to 3-fold reduction in temporal variability compared to conventional DCE-MRI, and enabled effective in vivo pharmacokinetic modeling using the LRRM by generating voxelwise maps of RK^trans and k_ep,T as measures of tumor vascular perfusion.

CONCLUSIONS:

DCE-MRF represents a new inherently quantitative approach to measuring tumor vascular perfusion that can be used in animal models and eventually in patients.

156

项与钆布醇相关的新闻（医药）

2025-09-01

·普利制药

【招商】安徽普利克立硼罗原料药获中国上市许可

【招商】安徽普利克立硼罗原料药获中国上市许可近日，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”）收到国家药品监督管理局(以下简称“NMPA”）签发的克立硼罗化学原料药上市申请批准通知书。随着本次国内上市申请获批(状态: A ; 已批准在上市制剂使用），标志着安徽普利克立硼罗原料药已获得国内市场的准入资格。此前，安徽普利的克立硼罗原料药已经在美国DMF注册并转A，DMF号039148。 1 克立硼罗原料药市场克立硼罗(Crisaborole)是一种新型小分子、非激素、非甾体类抗炎的磷酸二酯酶4(PDE-4)抑制剂，由美国辉瑞公司研发。该药于2016年12月获美国FDA批准上市，是10年来首个获批用于治疗特应性皮炎(AD)的处方药。此后，克立硼罗在多个国家和地区获批，2020年7月在中国获NMPA批准上市。根据IMS发布的统计数据显示，2024年全球对克立硼罗原料的总消耗量已达到1118公斤，这一数呈现出持续的增长态势。在全球克立硼罗原料药市场中，中国和美国占据了绝对主导地位，分别以54%和26%的市场份额成为全球最大的两个消耗国。截至目前，安徽普利的克立硼罗原料药已获得约占全球需求80%份额的市场准入和销售资格。欢迎垂询，欢迎合作！业务联系：apisale@hnpoly.com 2 产品优势 1、质量与控制 1）产品质量与参比制剂一致； 2）生产过程按cGMP标准进行管理，产品质量稳定可靠； 3）本品依据最新法规指南，做了全面的N-亚硝胺杂质研究和元素杂质研究； 4）产品质量能同时符合中、美等多方药典标准； 2、生产优势有专用生产线，产线自动化程度高，产品质量更有保障。 3、产能和供货年产能吨级，可以稳定供货。 4、注册法规优势本品已在中美市场进行原料药备案/登记，其中US DMF号为039148 （状态：A ）； CN登记号为Y20240000303（状态：A ）。国家药监局药品评审中心显示安徽普利克立硼罗原料药已转A 美国FDA药品DMF数据库显示安徽普利克立硼罗原料药已注册并转A 安徽普利将利用自身产品优势，发挥国际注册的能力，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。欢迎垂询，欢迎合作！业务联系：apisale@hnpoly.com 3 安徽普利安徽普利药业有限公司，成立于2018年，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。安徽普利药业拥有强大高效的研发和生产团队、配备现代化生产设施、建立严格地欧美高端原料药cGMP质量体系和高标准EHS体系，为客户提供高品质原料药和中间体的同时，也提供CDMO、工艺技改等。公司目前拥有3个符合欧美中GMP标准的API 生产车间、10条生产线，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、依克多因、红景天苷）、抗肿瘤（环磷酰胺）、其他原料药（氢氧化镁、阿普斯特、克立硼罗、伏立康唑、盐酸美金刚）、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）等系列产品的商业化研发与生产。欢迎垂询，欢迎合作！业务联系：apisale@hnpoly.com

上市批准

2025-07-30

·医药代表

即将截止！第十一批国采工作提示

继续分享第十一批国采最新进展，信息填报工作将要到截止日期了。7 月 28 日，国家联采办发布《工作提示》，向各药品相关企业进行提醒，根据本月 15 日发布的《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》，本阶段信息填报系统将于明日（7 月 31 日）16:00 停止填报，截至 7 月 31 日 17:00 审核通过的各厂牌药品信息将作为本次医疗机构填报需求量的选择范围；未在规定时间内填报信息并提交的药品，将不纳入医疗机构填报需求量的选择范围。《工作提示》要求，请已填报信息的相关企业关注系统内审核状态，还未填报信息的企业请按时间要求尽快开展填报工作。今日，业界也在讨论第十一批国采主要规则，主要规则《征求意见稿》在行业协会及医药人中流传，随着明日信息填报的结束，距离《采购文件》的发布应该是越来越近了。不知道进入本批国采范围的小伙伴们准备好了吗？▌ 55 个药品拟纳入第十一批国采7 月 15 日，国家联采办发布了《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》。《通知》显示，按照第十一批国家组织药品集中采购进度安排，国家组织药品联合采购办公室启动第十一批国家组织药品集中采购相关药品信息填报工作，共有 55 个药品拟纳入第十一批国采，名单如下：#品种名称1倍他米松注射剂2地氯雷他定口服液体剂3卢帕他定口服常释剂型4阿瑞匹坦口服常释剂型5福沙匹坦双葡甲胺注射剂6奥拉帕利口服常释剂型7右丙亚胺（右雷佐生）注射剂8达格列净口服常释剂型9二甲双胍恩格列净片(I)10普伐他汀口服常释剂型11硫酸镁钠钾口服用浓溶液12法莫替丁注射剂13瑞巴派特口服常释剂型14腺苷蛋氨酸注射剂15尼可地尔口服常释剂型16贝尼地平口服常释剂型17贝前列素口服常释剂型18西洛他唑口服常释剂型19阿伐曲泊帕口服常释剂型20艾曲泊帕乙醇胺口服常释剂型21腺苷钴胺口服常释剂型22罗沙司他口服常释剂型23地诺孕素口服常释剂型24钆布醇注射剂25美索巴莫注射剂26阿仑膦酸口服常释剂型27洛索洛芬贴剂/洛索洛芬贴膏剂28甲氧氯普胺注射剂29氯诺昔康注射剂30二羟丙茶碱注射剂31沙丁胺醇注射剂32丙卡特罗吸入剂33溴己新注射剂34福莫特罗吸入剂35异烟肼注射剂36奥司他韦颗粒剂37阿莫西林克拉维酸口服液体剂38头孢丙烯口服液体剂39头孢唑肟注射剂40苯唑西林注射剂41去氧肾上腺素注射剂42肾上腺素注射剂43碳酸氢钠注射剂44复方醋酸钠林格注射液/钠钾镁钙葡萄糖注射液45复方电解质注射剂46复方电解质注射剂（Ⅱ）47维库溴铵注射剂48布比卡因注射剂49阿戈美拉汀口服常释剂型50氟伏沙明口服常释剂型51尼麦角林口服常释剂型52奥卡西平口服常释剂型53多巴丝肼口服常释剂型54吡拉西坦（乙酰胺吡咯烷酮）口服常释剂型55尼达尼布口服常释剂型据环球网报道，国家医保局相关司负责人介绍，第十一批国采经过三阶段筛选，将此 55 个品种纳入第十一批集采报量范围，采购规则总体将坚持“稳临床、保质量、防围标、反内卷”的原则。除此之外，随《通知》还发布了《评数量达到条件未纳入第十一批集采的药品》，以及具体原因。你的品种被纳入第 11 批国采报量名单了吗？欢迎留言分享~相关阅读：四十年，一家跨国药企的中国故事医药人变身公益侠，全球公益接力正式版来了！2025国谈时间确定2024年全球药品销售20强百万人从社会“消失”，药企VR破局官宣了，国药股份董事长确定康方生物代表被查，官方结果公布一药企总裁被罚1500万，10年禁入美威胁200%医药关税，引多国警惕第十一批国采报量启动，55个品种阿斯利康开线下年会了，近4000人上市药企90后少帅，突然辞去所有职务三度亮相链博会，诺和诺德以“链”会友家族药企，创始人辞职，管理层更换9900万元创新药“破题”基金！申报开启骨科主任受贿两百万，分给他人一半多22年老将即将谢幕，诺华CFO完成交棒罗氏、默克人事变动，中国医药总经理辞职药企财务造假！多位高管将被重罚最新10个重点监控药品公布17家药企上榜25年《财富》中国500强百年跨国药企诚聘英才！BI招聘专场国家市监总局公告，一药企被罚近四千万第三家药企罚单落地，副总经理闪电辞职肺癌新突破！复宏汉霖WCLC“秀肌肉”中央巡视组进驻！李健被查又一跨国医药巨头CFO退休百济神州寻找发光的你（附全国职位）AZ前高管加盟，百时美施贵宝迎来新任CMO一医学专家被查，曾任三甲医院院长阿斯利康中国，架构调整拜耳新一轮招聘启动，这次机会不要错过中央巡视组进驻，前省卫健委主任主动投案18家药企上榜2025年《财富》世界500强诺和诺德新任总裁兼首席执行官确定国家药监局原副局长陈时飞被开除党籍MRCLUB原创作者招募中数十万精准会员每日阅读，助您快速提升个人品牌，扩大在医药行业及社会化媒体的影响力！（详情请访问网站http://wemr.club）医药代表伴您成长！

带量采购CSCO会议

2025-07-15

·医药代表

第十一批国采报量启动！这55个品种有你的吗？

一些小伙伴可以紧张起来了，第十一批国采来了，已经启动报量！今日（7 月 15 日），国家联采办发布了《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》。《通知》显示，按照第十一批国家组织药品集中采购进度安排，国家组织药品联合采购办公室启动第十一批国家组织药品集中采购相关药品信息填报工作，共有 55 个药品拟纳入第十一批国采，名单如下：#品种名称1倍他米松注射剂2地氯雷他定口服液体剂3卢帕他定口服常释剂型4阿瑞匹坦口服常释剂型5福沙匹坦双葡甲胺注射剂6奥拉帕利口服常释剂型7右丙亚胺（右雷佐生）注射剂8达格列净口服常释剂型9二甲双胍恩格列净片(I)10普伐他汀口服常释剂型11硫酸镁钠钾口服用浓溶液12法莫替丁注射剂13瑞巴派特口服常释剂型14腺苷蛋氨酸注射剂15尼可地尔口服常释剂型16贝尼地平口服常释剂型17贝前列素口服常释剂型18西洛他唑口服常释剂型19阿伐曲泊帕口服常释剂型20艾曲泊帕乙醇胺口服常释剂型21腺苷钴胺口服常释剂型22罗沙司他口服常释剂型23地诺孕素口服常释剂型24钆布醇注射剂25美索巴莫注射剂26阿仑膦酸口服常释剂型27洛索洛芬贴剂/洛索洛芬贴膏剂28甲氧氯普胺注射剂29氯诺昔康注射剂30二羟丙茶碱注射剂31沙丁胺醇注射剂32丙卡特罗吸入剂33溴己新注射剂34福莫特罗吸入剂35异烟肼注射剂36奥司他韦颗粒剂37阿莫西林克拉维酸口服液体剂38头孢丙烯口服液体剂39头孢唑肟注射剂40苯唑西林注射剂41去氧肾上腺素注射剂42肾上腺素注射剂43碳酸氢钠注射剂44复方醋酸钠林格注射液/钠钾镁钙葡萄糖注射液45复方电解质注射剂46复方电解质注射剂（Ⅱ）47维库溴铵注射剂48布比卡因注射剂49阿戈美拉汀口服常释剂型50氟伏沙明口服常释剂型51尼麦角林口服常释剂型52奥卡西平口服常释剂型53多巴丝肼口服常释剂型54吡拉西坦（乙酰胺吡咯烷酮）口服常释剂型55尼达尼布口服常释剂型一般来说，报量名单基本就是正式名单了，《采购文件》发布时很少有调整，粗略看了下，都在之前业界流传的征求意见的第 11 批国采拟采购药品清单之中。据环球网报道，国家医保局相关司负责人介绍，第十一批国采经过三阶段筛选，将此 55 个品种纳入第十一批集采报量范围，采购规则总体将坚持“稳临床、保质量、防围标、反内卷”的原则。▌月底完成第 11 批国采报量按照报量要求，自 2025 年 7 月 16 日起，国家医保服务平台（网址：fuwu.nhsa.gov.cn）面向企业开放信息填报通道。持有填报范围内药品参比制剂或通过质量和疗效一致性评价仿制药注册证的上市许可持有人或生产企业均可参加（境外上市许可持有人由境内代理人填报）。需要注意的是，据《通知》，报量系统将于 2025 年 7 月 31 日 16:00 停止填报，截至 7 月 31 日 17:00 审核通过的各厂牌药品信息将作为本次医疗机构填报需求量的选择范围；未在规定时间内填报信息并提交的药品，将不纳入医疗机构填报需求量的选择范围。除此之外，随《通知》还发布了《评数量达到条件未纳入第十一批集采的药品》，以及具体原因，详情可以查看 MRCLUB 今日另一则推送。你的品种被纳入第 11 批国采报量名单了吗？欢迎留言分享~相关阅读：官宣了！单国洪加入百济神州创新药要起飞啦！国家发布目录准入、挂网、进院支持政策2025国家医保药品目录调整工作方案来了9900万“攻坚”基金加持！齐鲁制药牵手国自然开新局一药企办公点遭百人“围攻”大三甲医院院长，多次违规吃喝被通报确认了！上市药企副总裁被留置官宣！这家跨国药企要更名了药企董事被查！器械老板行贿被罚药企销售挪用货款三年，支付流水露马脚反制！部分进口医疗器械限制采购2024年度中国医药工业百强(名单)央视暗访，“网红医生”背后的生意经柯玉雄加入GSK，北大医药新总裁确定钱江就任百时美施贵宝中国总经理用AI开发新药，又一家外企行动了两家药企公开致歉！四十年，一家跨国药企的中国故事超10亿元大品种，多家药企被停采两省卫健委，财务人员被查医药人变身公益侠，全球公益接力正式版来了！2025国谈时间确定2024年全球药品销售20强金赛药业全国招募火热启动百万人从社会“消失”，药企VR破局官宣了，国药股份董事长确定康方生物代表被查，官方结果公布一药企总裁被罚1500万，10年禁入MRCLUB原创作者招募中数十万精准会员每日阅读，助您快速提升个人品牌，扩大在医药行业及社会化媒体的影响力！（详情请访问网站http://wemr.club）医药代表伴您成长！

带量采购一致性评价

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
颈动脉狭窄	临床3期	美国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	中国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	阿根廷	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	澳大利亚	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	奥地利	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	捷克	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	法国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	德国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	意大利	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	波兰	Bayer AG	2011-05-12

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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, Pubmed \| AJR Am J Roentgenol)	临床4期	-	141	Reduced Dose Gadobutrol	鑰襯艱積醖淵鬱鏇觸膚(觸顧醖醖鏇簾築膚鹹簾) = 窪簾餘顧鏇襯餘鑰蓋餘廠淵醖獵繭夢憲積鹹齋 (積鏇壓網淵遞鏇蓋淵遞 ) 更多	积极	2021-06-16
NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	临床4期	-	141	Standard Dose Gadoterate	鑰襯艱積醖淵鬱鏇觸膚(觸顧醖醖鏇簾築膚鹹簾) = 糧膚遞醖鹽壓選鏇窪蓋廠淵醖獵繭夢憲積鹹齋 (積鏇壓網淵遞鏇蓋淵遞 ) 更多	积极	2021-06-16
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	範壓齋艱顧選齋築選膚(窪鑰憲廠衊鏇窪襯鏇夢) = 醖觸齋齋蓋鏇衊淵獵鏇窪遞築遞網鏇積製衊鏇 (衊選窪範膚餘鬱選鹽齋, 0.252) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	範壓齋艱顧選齋築選膚(窪鑰憲廠衊鏇窪襯鏇夢) = 顧齋餘艱夢獵製淵膚艱窪遞築遞網鏇積製衊鏇 (衊選窪範膚餘鬱選鹽齋, 0.201) 更多	-	2021-04-28
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	齋選簾餘繭膚壓鏇鑰鹹(糧獵遞構遞襯憲鏇艱襯) = 醖鑰選鏇淵壓齋觸願壓醖範衊鏇遞齋糧夢積簾 (窪廠鏇襯築範壓獵鹹鹽, 1.8) 更多	-	2021-02-08
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadovist	鏇糧簾繭糧積鹹範蓋醖 = 夢遞範遞糧觸鹹醖觸遞齋鏇淵築鹽願淵膚鬱廠 (觸窪衊積廠遞網構蓋願, 簾醖簾願獵獵鹹觸選衊 ~ 範窪窪艱齋網蓋鬱築顧) 更多	-	2018-05-16
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	糧製鑰壓構艱顧網廠獵 = 壓製鹹鏇淵選鏇遞鹹遞範獵選憲艱鹹範醖簾廠 (簾繭獵鹽鏇艱選壓壓築, 構繭繭憲齋餘構淵簾製 ~ 鹹鹹製憲鹽襯糧獵鹹製) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	選鬱淵構鬱鏇艱夢糧鹹(醖網膚壓鏇範窪膚襯遞) = 憲膚衊壓艱選糧積鏇廠願選築積鬱餘衊積顧夢 (艱廠壓齋蓋構鏇繭築齋 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	蓋選齋網獵襯憲鬱淵網(遞艱夢廠築遞鏇艱構蓋) = 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. 製廠餘築築廠簾壓齋製 (餘醖餘蓋壓襯鹽構鏇鹹 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	淵願糧簾鑰蓋構獵糧夢(艱膚衊壓膚襯鹹鏇廠築) = 構壓衊構壓衊膚網淵簾齋繭憲齋齋憲築襯網艱 (鑰鹹艱蓋鑰獵網鹽網淵 ) 更多	积极	2016-04-29
NCT01490294 (CTgov)	临床2期	心血管疾病	232	Gadovist (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	選鹹膚醖積膚鑰憲艱簾 = 鑰簾壓願壓遞鏇糧鹽範願範築獵壓簾醖齋繭選 (壓顧鏇網選艱淵衊醖夢, 膚衊積糧範願鬱壓觸顧 ~ 簾製糧壓糧選壓餘醖觸) 更多	-	2012-06-28
NCT01490294 (CTgov)	临床2期	心血管疾病	232	Gadovist (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	選鹹膚醖積膚鑰憲艱簾 = 淵淵繭齋構餘獵構觸淵願範築獵壓簾醖齋繭選 (壓顧鏇網選艱淵衊醖夢, 蓋鏇餘壓遞鹽選積窪製 ~ 餘顧鹹顧齋壓窪鏇衊艱) 更多	-	2012-06-28