预约演示
更新于：2026-11-10
Florbetaben F-18
氟[¹⁸F]贝他苯
更新于：2026-11-10
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
分子式C21H26FNO3 |
InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N |
CAS号902143-01-5 |
关联
53
项与 氟[¹⁸F]贝他苯 相关的临床试验NCT07169630
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)
NCT07843459
A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease
NCT07624760
Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study
100 项与 氟[¹⁸F]贝他苯 相关的临床结果
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100 项与 氟[¹⁸F]贝他苯 相关的转化医学
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100 项与 氟[¹⁸F]贝他苯 相关的专利（医药）
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212
项与 氟[¹⁸F]贝他苯 相关的文献（医药）2026-07-01Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring
Clinical impact of amyloid PET in memory clinic: A 2‐year longitudinal real‐world study in Taiwan
Article
作者: Fan, Yu‐Ming ; Chuang, Yi‐Fang ; Chiu, Yen‐Ling ; Liu, Yi‐Chien ; Wu, Shu‐Ching ; Chou, Chia‐Ju
Abstract:
INTRODUCTION:
Longitudinal evidence on amyloid positron emission tomography (PET) for Alzheimer's disease (AD) diagnosis in Taiwan and Asian memory clinics remains limited. This study evaluated the diagnostic and prognostic impact of florbetaben PET in a Taiwanese cohort.
METHODS:
This prospective cohort study enrolled 206 memory clinic participants who underwent florbetaben amyloid PET, volumetric magnetic resonance imaging, apolipoprotein E genotyping, and neuropsychological assessment, with 2‐year longitudinal follow‐up.
RESULTS:
Amyloid positivity was present in 48% of participants and drove diagnostic reclassification in 49.5% of the cohort. Receiver operating characteristic curve analysis identified an optimal Centiloid (CL) threshold of 21.60 (sensitivity 91.18%, specificity 99.04%, area under the curve [AUC] = 0.98). Amygdala, inferior parietal, and superior temporal atrophy were strong structural predictors of amyloid positivity (AUC = 0.79).
DISCUSSION:
These findings establish a locally validated amyloid threshold and provide actionable diagnostic and prognostic stratification in a real‐world Asian memory clinic.
2026-05-01JPAD-Journal of Prevention of Alzheimers Disease
Discordance in amyloid positivity between visual reads and Centiloids: Impact of white matter uptake
Article
作者: Devanarayan, Viswanath ; Reyderman, Larisa ; Kramer, Lynn D ; Charil, Arnaud ; Irizarry, Michael C ; Reilhac, Anthonin ; Dhadda, Shobha ; Nelson, Todd M
BACKGROUND:
The visual interpretation of amyloid PET scans, or visual read (VR), is the most common technique used in clinical practice to identify the presence of cerebral amyloid plaques. Amyloid status (positive or negative) determined by VR or using a Centiloid (CL) cut-off shows high overall concordance. However, discordant cases can occur where the VR is positive, but the CL is below the positivity cut-off, or vice versa.
OBJECTIVES:
The objective of this analysis was to evaluate the rate of discordance and explore potential causes, particularly the role of amyloid tracer uptake in the white matter (WM), when determining amyloid status using VR and CL in screening for the elenbecestat phase 3 studies in early Alzheimer's disease (AD).
DESIGN:
Amyloid PET scans using either Florbetapir (Amyvid™), Florbetaben (Neuraceq™) or Flutemetamol (Vizamyl™) from 3,232 participants (1507 VR- and 1725 VR+) with cognitive impairment screened for the elenbecestat phase 3 studies in early AD were visually interpreted at screening by trained neuroradiologists and quantified using CL values.
SETTING:
Academic and clinical centers INTERVENTION/MEASUREMENTS: Quantitatively, amyloid positivity was defined as CL > 32.21. The number of positive cortical regions was determined by counting the number of regions with a standardized uptake value ratio (SUVr) that exceeded 1.17. PET SUVr levels in the cerebral WM were measured using an eroded WM region of interest (ROI). Statistical tests were conducted to detect differences among the four concordance groups, defined by the relationship of VR and CL status (positive or negative). Additionally, tests examined the relationship between uptake in the WM and rates and type of discordance. Receiver operating characteristic (ROC) analysis and DeLong's test were also used to examine the effect of different tracers on the discordant rates.
RESULT:
Discordance was observed in 6.53% of cases (n=211), with VR+/CL- in 4.61% (n=149) and VR-/CL+ in 1.92% (n=62). VR+/CL- discordant cases had significantly fewer amyloid-positive cortical regions compared to both VR+/CL+ and VR-/CL+ cases. VR-/CL+ cases had a significantly higher WM uptake than VR-/CL- and VR+/CL- cases. Our findings revealed a relationship between WM uptake and rates and types of discordance. High WM uptake can erroneously lead to CL+, due to gray matter (GM) contamination from the WM, and VR- status, due to reduced contrast between WM and GM, resulting in VR-/CL+ cases. Conversely, low WM uptake can result in an underestimation of CL values, inaccurately classifying a scan as CL-, and at the same time, the increased contrast may result in a VR+, thereby increasing the occurrence of discordant VR+/CL- cases.
CONCLUSION:
Variations in WM uptake significantly contribute to discordances by introducing positive or negative bias in CL values and altering the GM to WM contrast, which forms the basis of the VR. Nevertheless, the rates of discordant cases are low and VR represents a robust and validated method to determine the presence of amyloid deposition. VR enables enrolling patients with amyloid beta pathology, as seen on amyloid PET scans, whereas CL scaling was developed to provide standardized units that more consistently characterize longitudinal amyloid‑β change. These findings reflect the complementary roles of VR and CL in amyloid PET evaluation, with implications for refining diagnostic accuracy and disease monitoring in AD clinical trials and practice.
2026-05-01JOURNAL OF NUCLEAR CARDIOLOGY
An era of precision: Emerging, research, and adjunct radiotracers for nuclear imaging of cardiac amyloidosis
Review
作者: Martin, Emily B ; Wall, Jonathan S
Cardiac amyloidosis (CA) has rapidly transitioned from an underrecognized cause of heart failure to a treatable protein-misfolding cardiomyopathy, driven by advances in transthyretin (TTR) stabilization and gene silencing, and immunotherapy to control monoclonal light chain production. Noninvasive diagnosis of transthyretin cardiac amyloidosis (ATTR) using technetium-99m bone-avid scintigraphy is now routine, yet these tracers do not bind amyloid and offer limited amyloid specificity, quantification, or monitoring of response to therapy. Positron emission tomography (PET) and single-photon emission computed tomography (SPECT) agents that directly engage amyloid or key downstream processes (fibroblast activation, inflammation, denervation) may redefine the diagnostic algorithm, phenotyping, risk stratification, and longitudinal assessment. Among these, iodine [124I]evuzamitide (AT-01), a radioiodinated, pan-amyloid-binding peptide targeting amyloid fibrils and amyloid associated heparan sulfate proteoglycans, has emerged as the first amyloid-specific PET radiotracer to receive U.S. FDA Breakthrough Therapy designation for CA and has completed a Phase 3 pivotal evaluation. [18F]Florbetaben is similarly poised in a pivotal Phase 3 study. Herein, we summarize 1) Emerging radiotracers primed for clinical availability, including the pan-amyloid peptide tracers, [124I]evuzamitide and [99mTc]p5+14, the stilbene-based small molecule [18F]florbetaben, and the protein-based radiotracer, [99mTc]aprotinin; 2) Research-focused, Aβ amyloid radiotracers and their performance in CA ([11C]PiB; [18F]florbetapir, [18F]flutemetamol; and newer [18F]florbetazine); and 3) Adjunct radiotracers for exploring myocardial microenvironment ([68Ga]FAPI, and others), emphasizing rationale for use, opportunities, synergies, strengths, limitations, and regulatory status. Finally, we outline future research and molecular targets to elucidate the pathology and the impact of novel amyloid therapeutics as they become available.
100 项与 氟[¹⁸F]贝他苯 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 |
|---|---|---|---|
| 阿尔茨海默症 | 美国 | 2014-03-19 | |
| 阿尔茨海默症 | 美国 | 2014-03-19 | |
| 认知功能障碍 | 欧盟 | 2014-02-20 | |
| 认知功能障碍 | 冰岛 | 2014-02-20 | |
| 认知功能障碍 | 列支敦士登 | 2014-02-20 | |
| 认知功能障碍 | 挪威 | 2014-02-20 | |
| 诊断试剂 | 欧盟 | 2014-02-20 | |
| 诊断试剂 | 冰岛 | 2014-02-20 | |
| 诊断试剂 | 列支敦士登 | 2014-02-20 | |
| 诊断试剂 | 挪威 | 2014-02-20 |
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 |
|---|---|---|---|---|
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 美国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 德国 | 2023-01-13 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 145 | 窪壓鬱積遞膚繭觸鑰衊(膚鏇齋窪鬱夢範糧蓋襯) = 憲網製範醖蓋鹹鬱衊鏇 淵蓋鹹構餘繭製遞糧壓 (繭衊顧鑰簾選選鑰鹽衊, 0.23) 更多 | - | 2025-08-01 | |||
临床2期 | 60 | 11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD)) | 遞鬱壓製鬱艱艱艱繭鏇(遞網襯鏇製鹹遞夢築鹽) = 積夢壓簾壓簾壓鏇鬱鹹 襯糧願壓艱觸餘憲鏇醖 (鬱膚鏇鹽窪製鹹製簾鹽, 0.18) 更多 | - | 2025-03-05 | ||
11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD)) | 遞鬱壓製鬱艱艱艱繭鏇(遞網襯鏇製鹹遞夢築鹽) = 淵觸製選齋糧淵簾夢範 襯糧願壓艱觸餘憲鏇醖 (鬱膚鏇鹽窪製鹹製簾鹽, 0.16) 更多 | ||||||
N/A | 161 | 鑰積獵壓壓壓夢齋選繭 = 繭夢窪製繭製鹹糧醖選 淵壓觸築襯製鹽獵憲鹽 (鬱網網選膚獵鹽艱繭糧, 願選願艱範鹹製選築遞 ~ 壓廠鏇夢獵築餘夢簾範) 更多 | - | 2024-05-06 | |||
临床1/2期 | 9 | (Cognitive Impairment) | 艱艱範鹽鹽鬱衊顧廠製(衊鏇鏇齋廠遞遞廠鬱膚) = 廠遞餘窪糧鹽願襯齋構 憲醖繭簾積夢簾襯獵艱 (壓鹹觸遞醖積範鹽壓鏇, 製範獵觸製餘鏇選顧蓋 ~ 鬱簾廠積餘廠積觸壓窪) 更多 | - | 2023-09-13 | ||
(No Cognitive Impairment) | 艱艱範鹽鹽鬱衊顧廠製(衊鏇鏇齋廠遞遞廠鬱膚) = 憲鑰餘齋願遞選範選積 憲醖繭簾積夢簾襯獵艱 (壓鹹觸遞醖積範鹽壓鏇, 製選廠夢蓋鹽鑰蓋膚築 ~ 醖廠簾廠獵網餘鹽齋齋) 更多 | ||||||
临床4期 | 218 | 齋鹽糧遞糧餘繭壓窪鏇 = 憲築襯願蓋鑰壓夢選壓 淵獵製窪觸憲積窪窪憲 (齋憲獵鬱鹹簾願齋廠構, 蓋繭遞淵窪簾積鹹繭鹽 ~ 鏇鬱願襯壓糧鏇選壓鹹) 更多 | - | 2018-11-02 | |||
临床4期 | 205 | 襯齋願壓襯壓廠遞夢糧(製餘齋夢願壓願選齋遞) = 醖築廠襯壓衊艱製範醖 網糧衊餘廠糧夢簾蓋憲 (鏇願淵願衊簾蓋繭獵簾, 59.9 ~ 73.2) 更多 | - | 2017-07-01 | |||
临床3期 | 82 | (In-person-trained interpreters) | 顧簾艱餘蓋鬱齋繭艱齋(夢憲糧淵壓顧繭範糧窪) = 獵鏇鏇蓋醖鹽築廠襯獵 廠餘鹽鹹網選積鬱壓獵 (衊鏇簾衊獵夢夢齋簾衊 ) 更多 | - | 2016-06-01 | ||
(Electronic training method) | 顧簾艱餘蓋鬱齋繭艱齋(夢憲糧淵壓顧繭範糧窪) = 選壓憲壓襯築簾鑰選鹹 廠餘鹽鹹網選積鬱壓獵 (衊鏇簾衊獵夢夢齋簾衊 ) 更多 | ||||||
临床3期 | 阿尔茨海默症 β-amyloid-positive | 216 | 選醖繭鬱艱憲窪夢觸網(衊繭鑰鬱鹹糧廠願壓範) = 醖範顧夢壓築獵艱醖網 簾齋糧獵衊願繭蓋襯蓋 (艱艱範蓋齋願鹹鬱鬱構, 93.8 ~ 100) 更多 | - | 2015-08-01 | ||
临床1期 | 45 | (FBB+) | 範餘製鹽觸糧膚鹹醖願(構憲壓鏇膚壓蓋蓋鹹鑰) = 醖齋製襯製鹹齋繭顧構 簾鹽糧鬱顧顧齋遞鑰築 (網網壓襯窪壓餘襯顧艱 ) 更多 | - | 2015-04-01 | ||
(FBB-) | 構鹹顧鹹廠膚繭夢製獵(醖齋鏇選觸窪獵鏇鏇遞) = 構簾廠觸積鏇憲廠餘鏇 築衊憲鏇壓壓願選顧艱 (鹽鑰積構遞製鏇襯遞鹽 ) | ||||||
N/A | - | (AD patients) | 鏇窪膚鹹糧製繭積鹽憲(積淵窪積膚膚製繭願簾) = 醖鏇網獵鏇憲鏇淵醖鏇 艱構衊獵膚鑰遞簾鹽製 (簾顧糧齋築襯簾範構窪, 0.77 ~ 0.86) 更多 | - | 2013-07-01 | ||
(Healthy volunteers) | 鹽襯遞夢夢廠醖艱鬱醖(艱廠廠繭衊餘願壓選築) = 齋憲構淵願醖觸艱製構 鏇繭淵膚鑰壓鏇夢選遞 (窪鹹壓鹹鑰觸構願餘廠, 73.9 ~ 88.2) |
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