更新于：2024-06-22

Furosemide

呋塞米

更新于：2024-06-22

概要

概要

基本信息

简介Furosemide是属于NKCC2抑制剂的小分子药物，可阻止肾脏Henle升支中的钠-钾-氯共同转运体的活性。这种机制导致尿液产生增加，钠、氯和钾离子的重吸收减少，从而减少了体液潴留和血压。Furosemide主要被批准用于治疗水肿和高血压，通常还与充血性心力衰竭、肝硬化和肾功能障碍等情况相关。Furosemide于1964年1月首次获批，由跨国制药公司赛诺菲生产。

药物类型

小分子化药

别名

2-Furfurylamino-4-chloro-5-sulfamoylbenzoic acid、4-Chloro-5-sulfamoyl-N-furfuryl-anthranilic acid、4-Chloro-N-(2-furylmethyl)-5-sulfamoylanthranilic acid

+ [17]

靶点

NKCC2

作用机制

NKCC2抑制剂(钠钾氯协同转运蛋白-2抑制剂)

治疗领域

神经系统疾病心血管疾病泌尿生殖系统疾病+ [1]

在研适应症

慢性心力衰竭心源性水肿急性肺水肿+ [7]

非在研适应症

急性失代偿性心力衰竭终末期肾脏病音量过载

原研机构

Sanofi

在研机构

Fresenius Kabi USA LLCSanofi KK

Nichi-Iko Pharmaceutical Co., Ltd.

+ [10]

非在研机构

University of Michigan

Sanofi

最高研发阶段批准上市

首次获批日期

日本 (1965-05-01),

水肿高血压经前综合征+ [1]

最高研发阶段(中国)批准上市

特殊审评-

登录后查看首次获批时间轴

结构

分子式C12H11ClN2O5S

InChIKeyZZUFCTLCJUWOSV-UHFFFAOYSA-N

CAS号54-31-9

关联

314

项与呋塞米相关的临床试验

NCT06407401 / Not yet recruiting临床3期

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer; A Pragmatic Randomized Controlled Trial

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy.
The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

开始日期2024-12-01

申办/合作机构

Eortc

CTRI/2024/04/066053 / Not yet recruitingN/A

IMPACT OF PROTOCOLIZED DE-RESUSCITATION WITH FRUSEMIDE/RENAL REPLACEMENT THERAPY COMPARED WITH STANDARD INTERVENTION IN CRITICALLY ILL PATIENTS ON MORTALITY IN A TERTIARY CARE HOSPITAL

开始日期2024-05-05

申办/合作机构-

NCT06273397 / Not yet recruitingN/A

Acetazolamide or Metolazone in Acute Heart Failure

Impact of Acute Heart Failure:
According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.
Use of Diuretics in Acute Heart Failure:
Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.
Use of Metolazone and Acetazolamide:
Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).
Outcomes Measured by Major Studies:
Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.
Congestion Monitoring:
Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.
Aim of the study:
The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure.

开始日期2024-05-01

申办/合作机构

Clínica Alemana de Santiago SA

100 项与呋塞米相关的临床结果

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100 项与呋塞米相关的转化医学

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100 项与呋塞米相关的专利（医药）

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14,593

项与呋塞米相关的文献（医药）

2024-04-01·NMR in biomedicine

Dynamic parametric MRI and deep learning: Unveiling renal pathophysiology through accurate kidney size quantification

Article

作者: Seeliger, Erdmann ; Lippert, Christoph ; Waiczies, Sonia ; Gladytz, Thomas ; Cantow, Kathleen ; Millward, Jason M ; Klein, Tobias ; Niendorf, Thoralf ; Hummel, Luis

Abstract:

Renal pathologies often manifest as alterations in kidney size, providing a valuable avenue for employing dynamic parametric MRI as a means to derive kidney size measurements for the diagnosis, treatment, and monitoring of renal disease. Furthermore, this approach holds significant potential in supporting MRI data‐driven preclinical investigations into the intricate mechanisms underlying renal pathophysiology. The integration of deep learning algorithms is crucial in achieving rapid and precise segmentation of the kidney from temporally resolved parametric MRI, facilitating the use of kidney size as a meaningful (pre)clinical biomarker for renal disease. To explore this potential, we employed dynamic parametric T2 mapping of the kidney in rats in conjunction with a custom‐tailored deep dilated U‐Net (DDU‐Net) architecture. The architecture was trained, validated, and tested on manually segmented ground truth kidney data, with benchmarking against an analytical segmentation model and a self‐configuring no new U‐Net. Subsequently, we applied our approach to in vivo longitudinal MRI data, incorporating interventions that emulate clinically relevant scenarios in rats. Our approach achieved high performance metrics, including a Dice coefficient of 0.98, coefficient of determination of 0.92, and a mean absolute percentage error of 1.1% compared with ground truth. The DDU‐Net enabled automated and accurate quantification of acute changes in kidney size, such as aortic occlusion (−8% ± 1%), venous occlusion (5% ± 1%), furosemide administration (2% ± 1%), hypoxemia (−2% ± 1%), and contrast agent‐induced acute kidney injury (11% ± 1%). This approach can potentially be instrumental for the development of dynamic parametric MRI‐based tools for kidney disorders, offering unparalleled insights into renal pathophysiology.

2024-04-01·Journal of pediatric urology

Response to commentary re decreased percent change in renal pelvis diameter on diuretic functional magnetic resonance urography following administration of furosemide may help characterize unilateral uretero-pelvic junction obstruction

Letter

作者: Cho, Joo ; Kirsch, Andrew ; Janssen, Karmon ; Linam, Leann

2024-04-01·CPT: pharmacometrics & systems pharmacology

Maximum likelihood estimation of renal transporter ontogeny profiles for pediatric PBPK modeling

Article

作者: van Groen, Bianca D ; de Wildt, Saskia N ; Hunt, J Porter ; Dubinsky, Samuel ; Edginton, Andrea N ; Cheung, Kit Wun Kathy ; Watt, Kevin M ; McKnite, Autumn M ; Giacomini, Kathleen M

Abstract:

Optimal treatment of infants with many renally cleared drugs must account for maturational differences in renal transporter (RT) activity. Pediatric physiologically‐based pharmacokinetic (PBPK) models may incorporate RT activity, but this requires ontogeny profiles for RT activity in children, especially neonates, to predict drug disposition. Therefore, RT expression measurements from human kidney postmortem cortical tissue samples were normalized to represent a fraction of mature RT activity. Using these data, maximum likelihood estimated the distributions of RT activity across the pediatric age spectrum, including preterm and term neonates. PBPK models of four RT substrates (acyclovir, ciprofloxacin, furosemide, and meropenem) were evaluated with and without ontogeny profiles using average fold error (AFE), absolute average fold error (AAFE), and proportion of observations within the 5–95% prediction interval. Novel maximum likelihood profiles estimated ontogeny distributions for the following RT: OAT1, OAT3, OCT2, P‐gp, URAT1, BCRP, MATE1, MRP2, MRP4, and MATE‐2 K. Profiles for OAT3, P‐gp, and MATE1 improved infant furosemide and neonate meropenem PBPK model AFE from 0.08 to 0.70 and 0.53 to 1.34 and model AAFE from 12.08 to 1.44 and 2.09 to 1.36, respectively, and improved the percent of data within the 5–95% prediction interval from 48% to 98% for neonatal ciprofloxacin simulations, respectively. Even after accounting for other critical population‐specific maturational differences, novel RT ontogeny profiles substantially improved neonatal PBPK model performance, providing validated estimates of maturational differences in RT activity for optimal dosing in children.

198

项与呋塞米相关的新闻（医药）

2024-06-13

·米内网

【重磅】倍特药业拿下3大新品，抢食77亿品种

精彩内容 6月12日，NMPA官网发布最新药品获批信息，倍特药业同日获批了西洛他唑片、盐酸肾上腺素注射液以及注射用哌拉西林钠他唑巴坦钠。今年以来，倍特药业及子公司已有13个新产品获批。图1：倍特药业最新获批的产品来源：NMPA官网西洛他唑片是抗血栓形成药内服TOP11产品，2023年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端的销售额超过2.5亿元。盐酸肾上腺素注射液则是心脏病治疗用药畅销产品，2023年在中国公立医疗机构终端的销售额超过2.7亿元。上述两大产品目前均有超过20家国内药企获得生产批文，市场竞争激烈。图2：哌拉西林他唑巴坦的销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局哌拉西林他唑巴坦是全身用抗细菌药TOP2品种，2023年在中国公立医疗机构终端的销售额超过77亿元。目前该品种仅有注射剂获批上市，国产品牌领军市场。表1：倍特药业今年以来获批的新产品来源：米内网中国申报进度（MED）数据库今年以来，倍特药业收获颇丰，已拿下13个新产品，其中改良新药盐酸右美托咪定鼻喷雾剂为国产第二家，呋塞米口服溶液是国内首仿+首家过评，目前为独家产品。数据统计，倍特药业及子公司还有50多个新品报产在审，研发实力有目共睹。资料来源：米内网数据库、NMPA官网注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至6月13日，如有疏漏，欢迎指正。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准

2024-06-11

·信狐药迅

新药上市申请2个品规、仿制药申请9个品规、进口申请4个品规发通知件；临床申请品种均默示许可| 新获批（6.3-6.10）

每周药品注册获批数据，分门别类呈现，一目了然。(6.3-6.10）新药上市申请药品名称企业注册分类受理号兰索拉唑碳酸氢钠胶囊厦门恩成制药有限公司2.2CXHS2200046国;CXHS2200046林普利塞片上海璎黎药业有限公司2.4CXHS2300076醋酸奥曲肽注射液Novartis Pharma Schweiz AG5.1JXHS2200103国;JXHS2200103注射用A型肉毒毒素AbbVie Limited2.2JXSS2300048注射用A型肉毒毒素AbbVie Limited2.2JXSS2300047注射用A型肉毒毒素AbbVie Limited2.2JXSS2300046特立帕肽注射液无锡和邦生物科技有限公司3.3CXSS2200073国;CXSS2200073 新药临床申请药品名称企业注册分类受理号PF-07820435片Pfizer Inc.1JXHL2400074PF-07820435片Pfizer Inc.1JXHL2400073PF-07820435片Pfizer Inc.1JXHL2400072PF-07820435片Pfizer Inc.1JXHL2400071JAB-30355片北京加科思新药研发有限公司1CXHL2400310JAB-30355片北京加科思新药研发有限公司1CXHL2400309AXT-1003胶囊艾斯拓康医药科技(北京)有限公司1CXHL2400311MK-0616 片Merck Sharp & Dohme LLC1JXHL2400068HRS7415片江苏恒瑞医药股份有限公司1CXHL2400301HRS-8080片山东盛迪医药有限公司1CXHL2400300HRS-8080片山东盛迪医药有限公司1CXHL2400299LY3819469注射液Eli Lilly and Company1JXHL2400066BCM875口溶膜上海云晟研新生物科技有限公司2.2CXHL2400324BCM857口溶膜上海云晟研新生物科技有限公司2.2CXHL2400323BCM857口溶膜上海云晟研新生物科技有限公司2.2CXHL2400322LNP023胶囊Novartis Pharma AG2.4JXHL2400067布立西坦片宜昌人福药业有限责任公司3CYHL2400065布立西坦片宜昌人福药业有限责任公司3CYHL2400064呼吸道合胞病毒IN006二价mRNA疫苗深圳深信生物科技有限公司1.2CXSL2400187SasanlimabPfizer Inc.1JXSL2400064注射用聚乙二醇化促血小板生成肽重庆派金生物科技有限公司1CXSL2400205注射用HDM2005杭州中美华东制药有限公司1CXSL2400203HCB101注射液广州汉科生物有限公司1CXSL2400200ER2001注射液艾码生物科技(南京)有限公司1CXSL2400181 仿制药申请药品名称企业注册分类受理号水合氯醛灌肠剂宏越科技(湖州)有限公司3CYHS2401094乙酰半胱氨酸注射液德全药品(江苏)股份有限公司3CYHS2400165乙酰半胱氨酸注射液陕西丽彩药业有限公司3CYHS2302796乙酰半胱氨酸注射液舒美奇成都生物科技有限公司3CYHS2302530吡非尼酮片四川依科制药有限公司3CYHS2302435氨茶碱注射液北京百美特生物制药有限公司3CYHS2300685氨茶碱注射液北京百美特生物制药有限公司3CYHS2300684注射用盐酸罗沙替丁醋酸酯海南紫程众投生物科技有限公司3CYHS2300554注射用阿莫西林钠广东金城金素制药有限公司3CYHS2300326注射用阿莫西林钠广东金城金素制药有限公司3CYHS2300325注射用阿莫西林钠广东金城金素制药有限公司3CYHS2300324己酮可可碱注射液山东齐都药业有限公司3CYHS2300156盐酸纳洛酮注射液重庆莱美药业股份有限公司3CYHS2202015国;CYHS2202015富马酸福莫特罗吸入溶液上海奥科达医药科技股份有限公司3CYHS2202000国;CYHS2202000磷酸奥司他韦干混悬剂海南斯达制药有限公司3CYHS2201959国;CYHS2201959盐酸格拉司琼注射液德全药品(江苏)股份有限公司3CYHS2201790国;CYHS2201790呋塞米注射液中国大冢制药有限公司3CYHS2201761国;CYHS2201761门冬氨酸钾镁注射液洋浦京泰药业有限公司3CYHS2201691国;CYHS2201691门冬氨酸钾镁注射液洋浦京泰药业有限公司3CYHS2201690国;CYHS2201690帕拉米韦注射液四川美大康华康药业有限公司3CYHS2201567国;CYHS2201567地氯雷他定口服溶液江西施美药业股份有限公司3CYHS2201510国;CYHS2201510注射用盐酸罗沙替丁醋酸酯武汉海特生物制药股份有限公司3CYHS2201488国;CYHS2201488复方聚乙二醇(3350)电解质口服溶液浙江远力健药业有限责任公司3CYHS2201398国;CYHS2201398帕拉米韦注射液青海晨菲制药有限公司3CYHS2201390国;CYHS2201390帕拉米韦注射液温州海鹤药业有限公司3CYHS2201359国;CYHS2201359泊马度胺胶囊齐鲁制药有限公司3CYHS2201310国;CYHS2201310泊马度胺胶囊齐鲁制药有限公司3CYHS2201308国;CYHS2201308泊马度胺胶囊齐鲁制药有限公司3CYHS2201307国;CYHS2201307泊马度胺胶囊齐鲁制药有限公司3CYHS2201306国;CYHS2201306异烟肼注射液沈阳双鼎制药有限公司3CYHS2201267国;CYHS2201267恩替卡韦口服溶液湖北康源药业有限公司3CYHS2201059国;CYHS2201059维氟醌乳膏浙江孚诺医药股份有限公司3CYHS2200748国;CYHS2200748洛索洛芬钠细粒剂浙江恒研医药科技有限公司3CYHS2200568国;CYHS2200568磷酸奥司他韦干糖浆江西施美药业股份有限公司3CYHS2200416国;CYHS2200416乙酰半胱氨酸颗粒哈尔滨华瑞生化药业有限责任公司4CYHS2301906玻璃酸钠滴眼液广东汉丰百盛医药有限公司4CYHS2301905糠酸莫米松鼻喷雾剂四川普锐特药业有限公司4CYHS2301691玻璃酸钠滴眼液黑龙江省知润药业有限公司4CYHS2301362普拉洛芬滴眼液成都康弘药业集团股份有限公司4CYHS2300905吸入用乙酰半胱氨酸溶液苏州弘森药业股份有限公司4CYHS2300845磷酸奥司他韦胶囊四川依科制药有限公司4CYHS2300756比索洛尔氨氯地平片石家庄四药有限公司4CYHS2300518间苯三酚注射液重庆药谷制药有限公司4CYHS2300339奥拉帕利片南京方生和医药科技有限公司4CYHS2300075硝酸异山梨酯注射液华夏生生药业(北京)有限公司4CYHS2300092阿奇霉素片山西同达药业有限公司4CYHS2300043阿奇霉素片山西同达药业有限公司4CYHS2300042匹伐他汀钙片湖南恒生制药股份有限公司4CYHS2202120国;CYHS2202120西甲硅油乳剂江苏万高药业股份有限公司4CYHS2202138国;CYHS2202138盐酸莫西沙星滴眼液安徽环球药业股份有限公司4CYHS2202103国;CYHS2202103布洛芬混悬液天大医药科技(珠海)有限公司4CYHS2202085国;CYHS2202085磷酸奥司他韦胶囊南京道群医药研发有限公司4CYHS2202047国;CYHS2202047磷酸奥司他韦胶囊南京道群医药研发有限公司4CYHS2202046国;CYHS2202046聚多卡醇注射液仁合益康集团有限公司4CYHS2201961国;CYHS2201961聚多卡醇注射液仁合益康集团有限公司4CYHS2201960国;CYHS2201960恩他卡朋片石家庄四药有限公司4CYHS2201917国;CYHS2201917间苯三酚注射液合肥亿帆生物制药有限公司4CYHS2201905国;CYHS2201905尼莫地平注射液北京百美特生物制药有限公司4CYHS2201856国;CYHS2201856吸入用乙酰半胱氨酸溶液湖北兴华制药有限公司4CYHS2201818国;CYHS2201818奥拉帕利片石药集团欧意药业有限公司4CYHS2201808国;CYHS2201808奥拉帕利片石药集团欧意药业有限公司4CYHS2201807国;CYHS2201807西甲硅油乳剂武汉科福新药有限责任公司4CYHS2201732国;CYHS2201732替米沙坦片海南涛生医药科技研究院有限公司4CYHS2201709国;CYHS2201709替米沙坦片海南涛生医药科技研究院有限公司4CYHS2201708国;CYHS2201708玻璃酸钠滴眼液浙江尔婴药品有限公司4CYHS2201602国;CYHS2201602左乙拉西坦口服溶液合肥淡滨尼药业有限公司4CYHS2201595国;CYHS2201595醋酸阿比特龙片江苏联环药业股份有限公司4CYHS2201111国;CYHS2201111间苯三酚注射液重庆药友制药有限责任公司4CYHS2201071国;CYHS2201071间苯三酚注射液武汉天安医药科技有限公司4CYHS2200960国;CYHS2200960双醋瑞因胶囊江西欧氏药业有限责任公司4CYHS2200724国;CYHS2200724罗库溴铵注射液常州四药制药有限公司4CYHS2200384国;CYHS2200384阿加曲班注射液扬子江药业集团广州海瑞药业有限公司4CYHS2102359国;CYHS2102359 进口申请药品名称企业注册分类受理号拉考沙胺片Alembic Pharmaceuticals Limited5.2JYHS2200014国;JYHS2200014拉考沙胺片Alembic Pharmaceuticals Limited5.2JYHS2200013国;JYHS2200013拉考沙胺片Alembic Pharmaceuticals Limited5.2JYHS2200012国;JYHS2200012拉考沙胺片Alembic Pharmaceuticals Limited5.2JYHS2200011国;JYHS2200011左乙拉西坦口服溶液印度熙德隆制药有限公司5.2JXHS2000085国;JXHS2000085厄贝沙坦氢氯噻嗪片山德士(中国)制药有限公司5.2JXHS2000019国;JXHS2000019 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗信使RNA申请上市

2024-06-10

·BioSpace

Blue Earth Diagnostics Highlights Results of Studies Evaluating Impact of Urinary Activity on Image Interpretation and Performance of POSLUMA® (Flotufolastat F 18) and 18F-Flotufolastat PET in Prostate Cancer

MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)-- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced highlights from clinical studies conducted by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 8-11, 2024. They included interim results of a study by Emory University that evaluated POSLUMA® (flotufolastat F 18) injection PET/CT with and without furosemide in men with biochemically recurrent prostate cancer (BCR), as well as results of a retrospective study conducted by the Technical University of Munich (TUM) that evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer. The studies build upon a recently published post-hoc analysis of Blue Earth Diagnostics’ clinical studies in which POSLUMA demonstrated low urinary bladder interference that did not impact disease assessment in the vast majority of patients1. Links to the abstracts follow below. POSLUMA is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 18F-Flotufolastat produced at TUM is an investigational agent for which the safety and efficacy have not been established by the U.S. Food and Drug Administration. “The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” said Eugene Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer of Blue Earth Diagnostics. “Activity in the urinary tract, especially in the urinary bladder, is a common feature of FDA-approved PSMA-PET radiopharmaceuticals which are excreted via the urine. High urinary activity can potentially obscure tumors in the prostate region and regional lymph nodes in the pelvis, which are common sites of recurrence, and interfere with accurate image interpretation.” Dr. Teoh continued, “These results reported at SNMMI support our previous experience with POSLUMA and are broadly consistent with results from our clinical trials. A post-hoc analysis of our Phase 3 clinical trials demonstrated that 96% of patients (682/712) exhibited either no urinary activity or activity that was easily distinguishable from disease1. Although furosemide usage has been widely described for other PSMA PET imaging agents as a potential means to reduce urinary activity, the POSLUMA Phase 3 trial results were achieved without its use. In cases from this Emory study where furosemide was not used, results also demonstrate the high POSLUMA detection rates in patients with low PSA levels as observed in prior Blue Earth Diagnostics clinical trials.” “These findings from Emory and TUM reinforce important clinical considerations in selecting a precision diagnostic imaging agent for PSMA-PET procedures,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA provides physicians with useful information based on its performance at low PSA levels, PSMA binding and low urinary bladder activity. It is included in nationally recognized clinical oncology guidelines for prostate cancer and covered by the vast majority of insurance plans. Labeled with the radioisotope fluorine-18 (18F) to leverage high image quality, POSLUMA is widely available through the network of our commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.” Highlights of the Abstracts Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial Interim results from a prospective study were presented by Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga. The study investigated the impact of forced diuresis with furosemide during 18F-flotufolastat PET/CT imaging for further improved bladder activity and prostate bed region recurrence detection in BCR. Twelve men had completed both with- and without-furosemide PET/CT scans at the time of the interim analysis. The study assessed bladder activity by SUV, patient-level recurrence and recurrence in the prostate-bed region. The authors concluded that furosemide-augmented bladder activity reduction showed no safety issues and was feasible for 18F-flotufolastat PET/CT imaging. While recognizing detection rates without furosemide remain high and consistent with Phase 3 studies, recurrence detection may be enhanced with the use of furosemide, by further decreasing observed urinary activity, and with no impact on the radiotracer avidity in the recurrent lesion. The full abstract is available here. Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat- and 68Ga-PSMA-11-PET Results from a retrospective study were presented by Isabel Rauscher, MD, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany. The study evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in a matched cohort of 62 patients staged for primary prostate cancer. Parameters included overall interference from bladder activity, scoring of median semi-quantitative bladder activity, presence of ureteral retention and halo artifacts, and tumor-to-bladder uptake ratio. The authors concluded that interpretation of 68Ga-PSMA-11 PET was significantly more impacted by bladder activity than 18F-flotufolastat PET in the matched populations of primary prostate cancer patients. The full abstract is available here. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . 1Kuo PH, Hermsen R, Penny R, Postem EJ. Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3 PET/CT. Mol Imaging Biol. 2024 Feb;26(1):53-60. doi: 10.1007/s11307-023-01867-w. POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd. PP-rh-US-0499 This press release is for U.S. audiences only View source version on businesswire.com: Contacts For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799-7917 priscilla.harlan@blueearthdx.com For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0) 7917 536939 clare.gidley@blueearthdx.com Media Mike Beyer (M) (312) 961-2502 mikebeyer@sambrown.com Source: Blue Earth Diagnostics View this news release online at:

临床结果临床3期

100 项与呋塞米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00331	呋塞米	C03CA01	DB00695

研发状态

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适应症	国家/地区	公司	日期
慢性心力衰竭	美国	scPharmaceuticals, Inc.	2022-10-07
心源性水肿	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2002-10-31
急性肺水肿	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1991-08-01
脑水肿	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1991-08-01
少尿	日本	Sanofi KK	1981-09-01
水肿	日本	Sanofi KK	1965-05-01
高血压	日本	Sanofi KK	1965-05-01
经前综合征	日本	Sanofi KK	1965-05-01
泌尿结石	日本	Sanofi KK	1965-05-01

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适应症	最高研发状态	国家/地区	公司	日期
急性失代偿性心力衰竭	临床2期	美国	scPharmaceuticals, Inc.	2016-05-01
急性失代偿性心力衰竭	临床2期	美国	University of Michigan	2016-05-01
心脏衰竭	临床2期	荷兰	scPharmaceuticals, Inc.	2014-12-01
音量过载	临床2期	荷兰	scPharmaceuticals, Inc.	2014-12-01
终末期肾脏病	临床1期	加拿大	Sanofi	2012-11-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AUA2024	N/A	肾积水	-	LASIX	鬱壓憲夢選壓鏇窪願鹹(鏇蓋餘廠顧範膚餘醖壓) = 製願壓齋蓋遞蓋鹽積廠壓鏇襯製憲齋衊艱顧餘 (鬱蓋廠夢憲繭醖積艱齋 ) 更多	-	2024-05-01
				LASIX	艱淵遞網築壓獵壓齋襯(鑰襯鬱簾製範襯壓簾鏇) = 鑰壓鹽憲襯齋觸夢醖壓餘糧製淵繭壓夢憲膚繭 (鏇膚鑰積餘廠願鏇鹽簾, -67% ~ -6.0%)
NCT04615624 (CTgov)	临床3期	先兆子痫	65	Furosemide (Furosemide)	艱遞衊衊齋繭壓夢獵衊(窪夢艱襯築觸遞積醖醖) = 蓋簾簾窪蓋膚壓淵餘積鬱構廠繭鬱廠觸遞鑰選 (壓齋鬱餘齋廠醖鏇積窪, 糧範簾糧夢觸壓齋鏇鏇 ~ 襯鏇窪構壓淵壓積膚網) 更多	-	2024-04-18
				Placebo (Placebo)	艱遞衊衊齋繭壓夢獵衊(窪夢艱襯築觸遞積醖醖) = 糧積夢鹹選遞蓋艱願夢鬱構廠繭鬱廠觸遞鑰選 (壓齋鬱餘齋廠醖鏇積窪, 構選網衊選衊窪廠窪繭 ~ 淵築積鹽選構願積顧壓) 更多
NCT04919564 (CTgov)	临床2期	功能障碍 \| 心脏病 \| 慢性肾病	90	Furosemide (Furosemide)	範選鹹選獵顧衊觸夢醖(顧廠構築憲簾醖範鬱淵) = 蓋築膚壓襯顧齋鹽範獵繭製衊築築糧淵壓膚艱 (網艱網壓夢範餘繭鏇繭, 鑰醖顧鏇膚鏇膚構憲艱 ~ 憲鑰衊糧選憲鹽壓廠夢) 更多	-	2024-01-05
				NaCl (Control)	範選鹹選獵顧衊觸夢醖(顧廠構築憲簾醖範鬱淵) = 廠鹹壓鹹襯鏇淵鑰壓鏇繭製衊築築糧淵壓膚艱 (網艱網壓夢範餘繭鏇繭, 鹹壓淵壓顧襯鬱淵淵鏇 ~ 鹹醖積繭醖積獵膚鹹簾) 更多
NCT04982874 (CTgov)	N/A	-	24	Furosemide 40 mg (Furosemide 40 mg Tablet)	齋艱獵蓋醖鑰醖餘顧選(顧構艱構糧壓夢繭憲鹽) = 觸鹽範鬱淵廠鑰獵憲鹽範糧願憲醖壓顧鑰製淵 (構壓鑰蓋觸衊窪構廠鑰, 蓋廠壓顧顧鬱廠遞願選 ~ 築網餘願築選艱顧簾壓) 更多	-	2023-11-02
				Lasix® 40 mg Tablet (Lasix® 40 mg Tablet)	製鏇鏇鹽蓋願淵襯鏇膚(積淵遞鏇簾構衊構窪蓋) = 衊積齋築鏇鹹襯觸憲壓遞窪糧獵壓選積顧簾製 (觸襯鏇夢鹽觸廠衊觸餘, 鏇蓋壓夢鬱蓋憲醖襯繭 ~ 遞獵範遞襯廠鹽觸膚淵) 更多
NCT04343235 (CTgov)	临床4期	妊娠期高血压	13	labetalol+Furosemide (Labetalol + Furosemide)	觸廠範遞壓鏇鹽構衊淵(構膚醖鏇鹽衊鹽蓋簾鑰) = 範選窪齋鬱積鬱憲憲衊鏇夢膚選襯襯鏇淵鑰夢 (網壓鑰糧窪選顧蓋顧築, 鹽衊鹽糧獵顧選夢獵築 ~ 憲觸積構衊網簾餘鏇獵) 更多	-	2023-10-23
				labetalol (Labetalol Only)	觸廠範遞壓鏇鹽構衊淵(構膚醖鏇鹽衊鹽蓋簾鑰) = 夢鹽窪醖繭夢築膚製齋鏇夢膚選襯襯鏇淵鑰夢 (網壓鑰糧窪選顧蓋顧築, 齋壓糧淵築製遞淵壓製 ~ 觸壓製鹽醖艱餘繭衊獵) 更多
NCT02971891 (CTgov)	临床3期	疣	484	CLS006 (Furosemide) Topical Gel (CLS006 (Furosemide))	蓋顧遞鏇艱襯齋廠醖餘(蓋餘顧夢醖遞簾簾網衊) = 獵鬱憲艱遞壓窪遞範憲網艱構蓋鑰選構鬱鑰蓋 (淵繭醖餘衊鏇膚壓鹹糧, 餘遞遞衊糧淵簾膚鹽壓 ~ 蓋鏇膚蓋齋衊製遞壓醖) 更多	-	2023-09-14
				Vehicle Topical Gel (Vehicle)	蓋顧遞鏇艱襯齋廠醖餘(蓋餘顧夢醖遞簾簾網衊) = 遞鹽衊夢窪鹽齋簾鏇衊網艱構蓋鑰選構鬱鑰蓋 (淵繭醖餘衊鏇膚壓鹹糧, 網鹹鑰醖憲願鏇壓蓋窪 ~ 遞遞範積齋簾膚顧夢膚) 更多
NCT03259620 (CTgov)	临床3期	疣	491	CLS006 (CLS006)	餘淵蓋淵選壓衊鹽夢積(願艱構憲選鹽積願築淵) = 糧艱廠淵顧獵範鹹襯觸淵築襯蓋膚鹽壓廠鏇齋 (艱鏇憲積顧醖繭積糧蓋, 淵願製築築繭蓋範衊顧 ~ 憲醖鏇遞遞範齋築壓積) 更多	-	2023-09-14
				CLS006 Vehicle (CLS006 Vehicle)	餘淵蓋淵選壓衊鹽夢積(願艱構憲選鹽積願築淵) = 獵鹹蓋鬱艱鹹壓觸壓繭淵築襯蓋膚鹽壓廠鏇齋 (艱鏇憲積顧醖繭積糧蓋, 憲鏇鑰鏇鏇憲壓網蓋鏇 ~ 簾壓選醖鏇選夢顧夢鹽) 更多
NCT03362515 (CTgov)	临床2期	鼻息肉	18	Furosemide (Furosemide)	壓餘積網蓋衊積憲築窪(壓獵廠憲鹽夢願遞顧膚) = 鹽鬱積醖製艱襯簾遞鏇餘窪製網淵網鏇膚願網 (憲觸窪窪觸廠齋繭願窪, 繭淵衊鑰鏇構餘艱積鏇 ~ 遞糧艱憲繭艱憲網構構) 更多	-	2023-08-30
				Placebo (Placebo)	壓餘積網蓋衊積憲築窪(壓獵廠憲鹽夢願遞顧膚) = 積壓鏇簾繭範夢鹽鬱壓餘窪製網淵網鏇膚願網 (憲觸窪窪觸廠齋繭願窪, 艱顧鹹製鬱獵網窪範衊 ~ 窪鑰製網觸構壓網襯壓) 更多
NCT01275729 (CTgov)	N/A	急性肾损伤	96	Furosemide	鬱艱獵夢範鹽窪齋獵窪(襯窪憲襯願艱衊壓襯糧) = 願憲範積製齋遞鹽夢夢鹽鏇積淵觸範鏇築鹹衊 (窪蓋齋願衊製壓蓋餘繭, 鹽蓋艱鏇遞遞鏇憲範範 ~ 簾襯範簾廠醖廠鬱鏇餘) 更多	-	2023-07-07
ESC2023	N/A	心脏衰竭	100	IV furosemide	顧醖鬱製鹽鑰壓夢醖壓(鬱艱鏇鏇鏇鹽願遞蓋範) = 獵壓顧願鬱鹹網築壓憲蓋蓋獵醖選顧遞淵選簾 (顧糧蓋網遞餘繭窪糧夢 )	-	2023-05-20
				IV torasemide	顧醖鬱製鹽鑰壓夢醖壓(鬱艱鏇鏇鏇鹽願遞蓋範) = 夢壓襯衊鹽膚蓋淵糧窪蓋蓋獵醖選顧遞淵選簾 (顧糧蓋網遞餘繭窪糧夢 )