更新于：2024-05-16

Ioforminol

更新于：2024-05-16

概要

研发状态

概要

基本信息

药物类型

造影剂、小分子化药

别名

Ioforminol (USAN/INN)

+ [3]

靶点-

作用机制

射线照相增强剂

治疗领域

心血管疾病内分泌与代谢疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

慢性肾病糖尿病心脏衰竭+ [1]

原研机构

GE Healthcare, Inc.

在研机构-

非在研机构

GE Healthcare, Inc.GE Healthcare Holdings, Inc.GE Healthcare Ltd. (United Kingdom)

+ [1]

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

结构

分子式C33H40I6N6O15

InChIKeyBFVVDRUCXCIALU-UHFFFAOYSA-N

CAS号1095110-48-7

关联

项与 Ioforminol 相关的临床试验

JPRN-JapicCTI-142517 / Unknown status临床2期

A phase 2, double-blind, randomized, safety and efficacy study of GE-145 versus Iodixanol in subjects undergoing cerebral angiography.

开始日期2014-05-01

申办/合作机构-

JPRN-JapicCTI-142518 / Unknown status临床2期

A phase 2, double-blind, randomized, safety and efficacy study of GE-145 versus Iodixanol in subjects undergoing peripheral angiography.

开始日期2014-04-16

申办/合作机构-

JPRN-JapicCTI-132391 / Unknown status临床2期

A phase 2, double-blind, randomized, safety and efficacy study of GE-145 versus Iohexol in subjects undergoing coronary angiography.

开始日期2013-11-01

申办/合作机构-

100 项与 Ioforminol 相关的临床结果

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100 项与 Ioforminol 相关的转化医学

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100 项与 Ioforminol 相关的专利（医药）

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项与 Ioforminol 相关的文献（医药）

2010-11-01·Acta Radiologica4区 · 医学

Predicting cardiotoxicity propensity of the novel iodinated contrast medium GE-145: Ventricular fibrillation during left coronary arteriography in pigs

4区 · 医学

Article

作者: Rasmussen, Henrik ; Hvoslef, Anne-Marie ; Chai, Chun-Ming ; Newton, Ben B. ; Eriksen, Morten ; Videm, Signe ; Evans, Paul

Background: Severe side effects caused by iodinated radiographic contrast media (CM) are rare, but can occur in high risk patients and during percutaneous coronary intervention. To minimize this risk a new nonionic CM with low inherent osmolality has been designed, giving room for a relatively high concentration of favorable electrolytes in the isotonic formulation. Purpose: To test a new radiographic CM (GE-145) in a pig model of cardiotoxicity by comparing its ventricular fibrillation (VF) propensity and hemodynamic effects to that of iodixanol. Material and Methods: Test agents were injected into the left anterior descending coronary artery (LAD) of pigs through an inflated balloon catheter (injection volume 25 ml, injection rate 0.4 ml/s, maximum injection time 62.5 s). Series 1: GE-145 (338 mg I/ml) + 45 mM NaCl and iodixanol (321 mg I/ml) + 19 mM NaCl were injected in five pigs. Series 2: GE-145 (320 mg I/ml) + 45 mM NaCl + 0.1, 0.3, or 0.7 mM CaCl2 and iodixanol (320 mg I/ml) + 19 mM NaCl + 0.3 mM CaCl2 (Visipaque) were injected in six pigs. Results: Iodixanol + NaCl caused VF in 6 of 13 injections (46%) after 60.3±7.5 s (mean ± SD). GE-145 + NaCl did not cause any VF in 13 injections (0%) ( P<0.05). Iodixanol + 19 mM NaCl + 0.3 mM CaCl2 caused VF in 9 of 9 injections (100%) after 61±4 s. GE-145 + 45 mM NaCl + 0.1, 0.3, or 0.7 mM CaCl2 did not cause any VF during or after 9 injections of each agent (0%) ( P<0.05). The least hemodynamic effects were seen with GE-145 + 45 mM NaCl + 0.7 mM CaCl2. Conclusion: In this model of direct administration of CM into the LAD of anesthetized pigs, the tested GE-145 formulations had a significantly lower propensity to induce VF than iodixanol with electrolytes. Favorable hemodynamic properties of GE-145 can be achieved by optimizing concentrations of sodium and calcium.

2010-11-01·Acta Radiologica4区 · 医学

GE-145, a new low-osmolar dimeric radiographic contrast medium

4区 · 医学

Article

作者: Hagelin, Gunnar ; Evans, Paul ; Rasmussen, Henrik ; Roed, Line ; Thaning, Mikkel ; Rogstad, Astri ; Grant, Derek ; Gram, Andreas ; Wistrand, Lars-G. ; Oulie, Inger ; Newton, Ben ; Iveson, Peter

Background: Contrast-induced nephrotoxicity is a significant risk when using radiographic contrast media clinically, especially in high risk patients. Consequently, there is a need for a new contrast agent with improved clinical safety with regards to nephrotoxicity. Purpose: To evaluate the physicochemical properties as well as the preclinical safety and biodistribution parameters of the newly developed radiographic contrast medium GE-145. Material and Methods: Standard methods for radiographic contrast media were used for evaluation of physicochemical properties. The acute toxicity in rats was studied at 8, 10, and 12.5 gI/kg, the clinical chemistry parameters were determined, and histology of the kidneys was performed. Biodistribution was studied in rats using 123I-labeled GE-145. Results: GE-145 is more hydrophilic than iodixanol and has a considerably lower osmolality. The viscosity is similar to that of iodixanol and the protein binding is low. The acute toxicity is similar to that of iodixanol and the biodistribution is similar to that of other radiographic contrast media, showing mainly renal excretion. Kidney histology showed a moderate reversible vacuolization, similar to that of iodixanol. Conclusion: GE-145 exhibits similar preclinical properties to other dimeric radiographic contrast media. In addition, the low osmolality enables an iso-osmolar formulation containing a significantly higher concentration of electrolytes than Visipaque.

100 项与 Ioforminol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10475	-	-	DB12439

研发状态

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
慢性肾病	临床2期	美国	GE Healthcare, Inc.	2010-11-01
糖尿病	临床2期	美国	GE Healthcare, Inc.	2010-11-01
心脏衰竭	临床2期	美国	GE Healthcare, Inc.	2010-11-01
血管疾病	临床2期	-	GE Healthcare, Inc.	-
血管疾病	临床2期	美国	GE Healthcare Ltd. (United Kingdom)	-
血管疾病	临床2期	日本	Daiichi Sankyo Co., Ltd.	-

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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


NCT01672996 (CTgov)	临床1/2期	-	66	Ioforminol (Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg)	積醖膚積鏇蓋餘積淵構(餘窪鹽鏇願餘製網醖鑰) = 獵簾遞遞鏇糧窪願鏇衊願築構願顧願鑰蓋壓築 (餘艱夢夢遞獵壓鏇蓋獵, 簾鹹夢蓋餘網憲範廠鹹 ~ 觸鏇鏇蓋膚糧艱鏇網顧) 更多	-	2014-03-03
				Ioforminol (Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg)	積醖膚積鏇蓋餘積淵構(餘窪鹽鏇願餘製網醖鑰) = 積網構襯壓獵窪淵艱夢願築構願顧願鑰蓋壓築 (餘艱夢夢遞獵壓鏇蓋獵, 鹹蓋衊膚餘觸遞齋遞醖 ~ 淵顧鏇淵齋遞壓餘繭餘) 更多
NCT01004770 (CTgov)	临床1/2期	-	50	GE-145 (GE-145 Injection-300mg of Iodine/mL)	(淵製夢淵窪願鑰遞窪鏇) = 襯廠衊糧糧衊築餘鹽範構艱簾鏇淵願餘襯鏇糧 (壓衊膚鏇鏇衊艱膚鹹積, 選蓋鏇顧網鏇醖餘廠製 ~ 願簾夢鏇鹽選憲繭窪範) 更多	-	2012-04-04
				GE-145 (GE-145 Injection-450mg of Iodine/mL)	(淵製夢淵窪願鑰遞窪鏇) = 觸壓窪憲製蓋夢艱蓋夢構艱簾鏇淵願餘襯鏇糧 (壓衊膚鏇鏇衊艱膚鹹積, 製夢衊選齋遞築願繭顧 ~ 鑰簾顧醖積簾觸鬱遞壓) 更多
NCT01252810 (CTgov)	临床2期	糖尿病 \| 心脏衰竭 \| 慢性肾病	284	GE-145	鑰顧積膚願憲鹽構夢積(繭壓鑰積鏇醖襯繭網鏇) = 積廠淵顧醖艱醖簾夢顧願範築獵製衊遞艱觸憲 (積積鑰選襯壓壓憲淵襯, 鏇鹹壓願觸窪顧築艱窪 ~ 觸鏇鏇餘選鏇築鑰鏇範) 更多	-	2014-05-02