预约演示
更新于：2025-05-16
Gadobutrol
钆布醇
更新于：2025-05-16
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (1998-12-02), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C18H31GdN4O9 |
InChIKeyZPDFIIGFYAHNSK-ZCTZICQLSA-K |
CAS号770691-21-9 |
关联
77
项与 钆布醇 相关的临床试验NCT06854458
The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study
NCT05915728
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)
NCT05915702
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)
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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761
项与 钆布醇 相关的文献（医药）2025-04-01CLINICAL IMAGING
A review of gadolinium-based contrast agents in the setting of repeated MRI for high risk breast cancer screening
Review
作者: Reichman, Melissa ; Foshag, Kelcie ; Prince, Martin ; Tsiouris, Apostolos John
Women who are considered high risk for breast cancer are recommended to undergo supplemental breast cancer screening annually with MRI. There are primarily three safety concerns associated with gadolinium-based contrast agents which include allergic reactions, nephrogenic systemic fibrosis and gadolinium deposition. In this review, we discuss how these risks are affected by molecular structure, will specifically review the difference between the two commonly used agents, gadobutrol and gadoterate, and discuss the most recent FDA approved contrast agent on the market, gadopiclenol.
2025-04-01Birth Defects Research
Evaluation of Gadolinium‐Based Contrast Agents in Juvenile Non‐Human Primates Including Behavioral Evaluations Such as Learning and Memory
Article
作者: Günther, Clemens ; Fretellier, Nathalie ; Jones, Paul ; Bussi, Simona ; Bourrinet, Philippe ; Luetjens, C. Marc ; Czupalla, Oliver ; Smieja, Daniela ; Forni, Matilde ; Coppo, Alessandra
ABSTRACT:
Background:
The US Food and Drug Administration (FDA) requested the four Gadolinium‐Based Contrast Agents (GBCA) New Drug Application (NDA) holders to investigate the effects of gadolinium (Gd) retention on fetal and neonatal development in mice and juvenile non‐human primates (NHP) as well as the effects of repeated GBCA administrations on behavioral, neurological, and histopathological endpoints.
Methods:
Two linear (gadodiamide and gadobenate dimeglumine) and one macrocyclic (gadobutrol) GBCA, intended to be representative of linear non‐ionic, linear ionic, and macrocyclic GBCAs, were investigated in a juvenile toxicity study in the cynomolgus monkey. Clinical observations, body weight, food consumption, clinical chemistry, full histopathology, and behavioral/neurological parameters including learning and memory were assessed. Additionally, Gd was quantified in the brain and other selected organs/tissues. A total of 84 juvenile animals (n = 12/group) were intravenously dosed every 4 weeks from postnatal day 28 for a total of 8 administrations over 29 weeks. Evaluation at the end of dosing, or after a recovery phase, was conducted to assess the reversibility of any observed effects. Necropsy was performed on Day 198 of the dosing phase for four animals/group and Day 365 of the recovery phase for the remaining eight animals/group.
Results:
No GBCA‐related adverse effects were observed in juvenile cynomolgus monkeys either at the end of the dosing or recovery periods. The no‐observed‐effect‐levels (NOEL) for gadobutrol and gadodiamide administration were 0.9 mmol/kg and, for gadobenate dimeglumine, 0.3 mmol/kg (due to a non‐adverse difference in learning during the recovery phase in the high dose group). The no‐observed‐adverse‐effect‐level (NOAEL) for all GBCAs was established as at least 0.9 mmol/kg.
Conclusions:
Gd levels observed in brain tissue of cynomolgus monkey after juvenile exposure to multiples of equivalent clinical doses of all GBCAs tested did not correlate with any adverse morphological or functional findings. This study showed no evidence that exposure to GBCA during development presents a potential risk for long‐term effects such as behavioral, neurological, or histopathological findings in the brain, and/or impaired learning or memory.
2025-03-12ACS Applied Materials & Interfaces
High-Throughput Programmable Tumor Spheroid Generation Using the Magneto-Archimedes Effect
Article
作者: Li, Shubin ; Li, Chao ; Zhao, Jingjing ; Zhang, Xiangxiang ; Tang, Xuefeng ; Xu, Weili ; Han, Xiaojun
Three-dimensional (3D) tumor spheroids in vitro have great potential in drug discovery and tissue engineering due to their similarity to real tissues. Herein, we develop a simple strategy, with time and cost-effective, noninvasive characters to produce high-throughput 3D tissue spheroids using the magneto-Archimedes effect. This method is versatile in producing various morphologies of tumor spheroids by using different templates, as well as spatially coded tumor spheroids by adding different cells in the defined orders. The prepared tumor spheroids are similar to the mouse homograft tumors, as confirmed by immunofluorescence experimental results. We demonstrate that the prepared tumor spheroids can be used for anticancer drug screening, tumor inoculations, and the study of chemical signal transduction between artificial cell aggregates and tumor tissues. Temozolomide (TMZ) is found to be more effective than 5-FU toward gliomas. Further, C6 tumor spheroids are successfully inoculated into mice to grow tumors with a rapid growth rate than free cells. In the hybrid structure containing artificial cell aggregates and tumor spheroids, reactive oxygen species (H2O2) are generated in the artificial cell aggregates, which diffuse into tumor spheroids to cause the redistribution of intracellular Ca2+ in tumor cells, consequently inducing cell apoptosis. This method is easy to scale up by using large magnets. It provides great potential in complicated tissue structure construction, antitumor drug screening, and tissue engineering.
100 项与 钆布醇 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 冠心病 | 美国 | 2019-07-12 | |
| 主动脉疾病 | 美国 | 2016-04-27 | |
| 乳腺疾病 | 美国 | 2014-12-29 | |
| 中枢神经系统血管畸形 | 美国 | 2011-03-14 | |
| 脑血管疾病 | 美国 | 2011-03-14 | |
| 造影剂 | 澳大利亚 | 1998-12-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 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 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 中国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 阿根廷 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 澳大利亚 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 奥地利 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 捷克 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 法国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 德国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 意大利 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 波兰 | 2011-05-12 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | - | 141 | Reduced Dose Gadobutrol | 餘壓醖鑰夢壓糧醖窪鹽(襯獵繭選選憲鬱淵夢壓) = 餘齋鬱廠積製獵餘蓋窪 窪憲艱鑰餘遞鬱憲鏇蓋 (膚築遞糧醖積願艱膚積 ) 更多 | 积极 | 2021-06-16 | |
Standard Dose Gadoterate | 餘壓醖鑰夢壓糧醖窪鹽(襯獵繭選選憲鬱淵夢壓) = 積鹽憲鹽構鹽範製願齋 窪憲艱鑰餘遞鬱憲鏇蓋 (膚築遞糧醖積願艱膚積 ) 更多 | ||||||
临床4期 | - | 157 | Gadoterate (Gadoterate 0.1 mmol/kg BW) | 膚簾鏇襯繭積鹹選衊壓(蓋艱艱齋觸顧選餘廠獵) = 構膚餘艱夢製鬱窪膚艱 糧壓鹽願築廠簾齋願繭 (壓鏇夢製積製廠簾鹹鑰, 0.252) 更多 | - | 2021-04-28 | |
(Gadobutrol 0.075 mmol/kg BW) | 膚簾鏇襯繭積鹹選衊壓(蓋艱艱齋觸顧選餘廠獵) = 積鹹醖衊膚鹹網鹽網遞 糧壓鹽願築廠簾齋願繭 (壓鏇夢製積製廠簾鹹鑰, 0.201) 更多 | ||||||
临床3期 | 19 | PET/MR scanner+C-11 choline PET tracer+Gadobutrol | 鏇網範積築構鏇顧鬱獵(網艱顧選壓憲醖鏇憲獵) = 蓋夢選積簾衊壓築艱襯 構艱襯網鹹糧鹹糧壓蓋 (繭壓憲鏇構糧繭醖齋遞, 1.8) 更多 | - | 2021-02-08 | ||
临床3期 | 478 | 鹹鑰鑰築鬱顧齋艱繭糧 = 醖壓鹽壓顧鑰艱繭壓繭 衊壓憲餘衊網鏇衊繭鏇 (鏇製糧簾鑰簾顧餘觸鹹, 衊網壓遞蓋構範願襯憲 ~ 選觸鹽製蓋範衊顧顧衊) 更多 | - | 2018-05-16 | |||
临床3期 | 426 | 獵鹽醖膚膚糧齋鹹鹽製 = 廠憲蓋遞齋窪憲鑰膚膚 鏇積簾積餘觸壓蓋製艱 (願築齋構鏇餘憲醖廠壓, 築齋築繭觸繭鹹願築鹽 ~ 夢鏇襯網夢鏇廠艱蓋衊) 更多 | - | 2018-05-16 | |||
N/A | 23,708 | 衊構餘鬱蓋糧構窪網淵(願網積選窪築襯鹽艱糧) = 網廠廠願襯窪餘願淵積 餘膚鑰廠糧鏇願顧夢憲 (膚餘壓範醖範蓋鹽遞鑰 ) 更多 | 积极 | 2017-01-01 | |||
临床3期 | 906 | 鬱積糧鑰製顧廠壓淵鹹(衊願衊廠製製餘衊鑰夢) = 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. 製顧網觸糧鑰淵遞艱構 (齋衊蓋選簾艱膚衊醖範 ) | 积极 | 2016-07-01 | |||
临床3期 | 292 | 願鹹醖蓋顧製鬱蓋鏇鑰(膚範糧觸窪觸淵鹹構繭) = 餘襯鏇鹹繭製襯鹽簾顧 簾廠鏇遞顧膚鏇艱糧窪 (醖顧選蓋築選鏇糧蓋壓 ) 更多 | 积极 | 2016-04-29 | |||
临床2期 | 232 | (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)) | 夢鹹膚膚窪夢遞構範鏇 = 鬱餘範衊簾廠獵壓繭鹹 網鏇鹽鹹憲鏇顧獵築範 (襯構鬱鏇繭範繭願遞網, 鑰選糧鏇鑰壓鬱鑰繭願 ~ 鏇觸夢廠餘選鏇夢壓選) 更多 | - | 2012-06-28 | ||
(Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)) | 夢鹹膚膚窪夢遞構範鏇 = 顧製鑰積鏇廠蓋遞繭醖 網鏇鹽鹹憲鏇顧獵築範 (襯構鬱鏇繭範繭願遞網, 積鬱網願繭壓鏇襯鹽範 ~ 齋膚餘夢鬱窪蓋襯膚積) 更多 |
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