氟[¹⁸F]贝他苯(Florbetaben F-18) - 药物靶点：APP_在研适应症：阿尔茨海默症，认知功能障碍，诊断试剂_专利_临床

概要

基本信息

药物类型

小分子化药、诊断用放射药物

别名

florbetaben (18F)、Florbetaben [¹⁸F]、氟比他班 F18

+ [8]

靶点

APP

作用方式

抑制剂

作用机制

APP抑制剂(β-淀粉状蛋白A4抑制剂)

治疗领域

神经系统疾病其他疾病肿瘤+ [4]

在研适应症

阿尔茨海默症认知功能障碍诊断试剂+ [3]

非在研适应症

脑淀粉样血管病唐氏综合征额颞痴呆+ [2]

原研机构

Piramal Pharma Limited

在研机构

Lantheus Holdings, Inc.

Isologic Innovative Radiopharmaceuticals Ltd.

北京先通国际医药科技股份有限公司

非在研机构

Life Molecular Imaging Ltd.Life Molecular Imaging GmbH (Germany)

权益机构

PharmaLogic Holdings Corp.

Lantheus Holdings, Inc.士宣生物科技（上海）有限公司

+ [4]

最高研发阶段批准上市

首次获批日期

欧盟 (2014-02-20),

认知功能障碍诊断试剂

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、快速通道 (美国)

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结构/序列

分子式C21H26FNO3

InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N

CAS号902143-01-5

关联

48

项与氟[¹⁸F]贝他苯相关的临床试验

NCT07624760

/ Not yet recruitingN/AIIT

Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study

The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET/MR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy. The main question it aims to answer is: Can ¹⁸F-florbetaben PET/MR identify systemic amyloid deposits across clinically and histologically defined patient groups?
Participants will:
* Be screened for eligibility and asked to sign an informed consent form
* Have their vital signs measured
* Receive a single intravenous injection of approximately 300 MBq ¹⁸F-florbetaben (Neuraceq®), followed by whole-body PET/MR imaging from skull base to below the kidneys. If MRI is contraindicated (e.g., pacemaker, severe claustrophobia), PET/CT will be performed instead. The scan takes approximately one hour, during which participants lie still in the scanner
* Be monitored during and after the scan for any side effects or adverse events
* Complete study participation at the end of the imaging session (single visit, no follow-up required)

开始日期2026-10-01

申办/合作机构

University of Zurich

NCT07169630

/ Recruiting临床1期IIT

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)

Background:
About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI.
Objective:
To test whether medical imaging using a new radiotracer ([18F]PF-06445974) can measure PDE4B in the brains of people with AD or MCI.
Eligibility:
People aged 50 years and older with AD or MCI. Healthy volunteers are also needed.
Design:
Participants will have up to 5 clinic visits with 3 imaging scans of the brain.
They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory.
Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each.
Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....

开始日期2026-06-10

申办/合作机构

National Institute of Mental Health

ACTRN12626000208303

/ Not yet recruitingN/AIIT

Finding the fibril in the haystack: A pilot study of Amyloid ([18F] Florbetaben) PET-CT in Peripheral Nerve Amyloidosis

开始日期2026-03-02

申办/合作机构

University of Sydney Union

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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215

项与氟[¹⁸F]贝他苯相关的文献（医药）

2026-05-01·JPAD-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 ; Charil, Arnaud ; Reyderman, Larisa ; Kramer, Lynn D ; 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.

2026-05-01·JOURNAL 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.

2026-03-01·Journal of Nuclear Medicine Technology

Quantitative Amyloid Brain Imaging: A Literature Review of the Centiloid Scale in Alzheimer Disease Evaluation

Review

作者: York, Benjamin ; Doroudinia, Abtin ; Colletti, Patrick M

Amyloid PET has become a pivotal imaging biomarker for Alzheimer disease (AD), enabling in vivo detection and quantification of β-amyloid deposition. However, variability in quantitative measurements across tracers, scanners, and analysis methods has considerably limited direct comparison of amyloid burden between studies and centers. To address this issue, the Centiloid Project has been developed to provide a standardized quantitative scale for amyloid PET, harmonizing results across tracers and institutions. In this literature review, we aim to summarize current evidence on the development, validation, and clinical application of the Centiloid scale in amyloid PET imaging, emphasizing its methodologic foundations, tracer-specific conversions, and diagnostic thresholds. Methods: A literature review was conducted using PubMed, Scopus, and Embase databases from January 2015 through October 2025. Search terms included "amyloid PET," "Centiloid," "SUVR," and "Alzheimer disease." We reviewed articles with quantitative amyloid PET analyses and Centiloid conversion and studies which compared multiple tracers using MIMneuro software Centiloid calibration. Results: The Centiloid method demonstrates strong intertracer and interscanner harmonization when standardized to the ¹¹C-Pittsburgh compound B reference, with high correlation (r ² > 0.9) across ¹⁸F-labeled tracers, including florbetapir, flutemetamol, and florbetaben. Most articles identified a Centiloid threshold between 20 and 25 Centiloids as indicative of significant amyloid pathology. Implementation of the Centiloid framework improved comparability across clinical trials and longitudinal studies, facilitating integration into the AT(N) research framework. Conclusion: The Centiloid scale represents a critical advancement in quantitative amyloid PET imaging, providing a universal reference that enhances data reproducibility, cross-trial comparisons, and clinical decision-making. Continued work is needed to expand standardization for novel tracers and hybrid imaging systems, ensuring full clinical translation of this metric in dementia imaging.

102

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2026-06-03

·先通医药

新型α放射性配体疗法临床数据亮相ASCO

点蓝色字关注“先通医药” 近日，先通医药自主研发的新型α粒子放射性配体疗法XTR022（[225Ac]Ac-XT381）的临床研究数据，在2026年美国临床肿瘤学会（ASCO）年会上以壁报形式公布。该研究旨在评估XTR022在既往接受过治疗、PSMA阳性mCRPC受试者中的安全性、耐受性和初步疗效。研究设计及进度该研究采用“3+3”剂量递增设计，XTR022每6周静脉给药一次，最多6个周期。截至2026年4月1日，共入组13例经治的PSMA阳性mCRPC受试者。受试者基线特征受试者中位年龄67.6岁，其中9例既往接受过≥3线治疗。基线PSA平均值为146.6 ng/mL。疗效数据在至少有一次治疗后PSA评估的13例受试者中，10例达到PSA50缓解（其中1例待确认），PSA50缓解率为76.9%；5例达到PSA90缓解，PSA90缓解率为38.5%。在9例有RECIST可测量病灶的受试者中，客观缓解率（ORR）为33.3%（3例部分缓解），疾病控制率（DCR）为88.9%。 1例70岁、既往接受过4线治疗的受试者，在完成6个周期50 kBq/kg治疗后，达到确认的部分缓解（cPR），PSA较基线下降97.7%。安全性数据 25~100kBq/kg剂量组，均未观察到剂量限制性毒性（DLT）。最常见的治疗相关不良事件为口干，均为1-2级。血液学相关不良事件：白细胞减少发生率46.2%（6/13），均为1-2级；淋巴细胞减少发生率38.5%（5/13），其中≥3级占15.4%（2/13）；血小板减少发生率23.1%（3/13），其中≥3级占7.7%（1/13）。其他实验室异常包括体重下降（23.1%）、谷草转氨酶升高（23.1%）、谷丙转氨酶升高（15.4%）、血胆红素升高（7.7%）。研究小结研究数据显示，XTR022在经多线治疗的mCRPC受试者中安全性可控，并展现出积极的初步抗肿瘤活性。研究结果证明，这款PSMA靶向新型α粒子放射性配体疗法展现出更大的治疗潜力，具备进一步临床开发的价值。注：PSMA：前列腺特异性膜抗原；mCRPC：转移性去势抵抗性前列腺癌；PSA：前列腺特异性抗原关于XTR022（[225Ac]Ac-XT381） XTR022是先通医药自主研发的新型α粒子放射性配体疗法，注册分类为1类创新药，采用全新分子设计，具有优异的PSMA靶向能力、肿瘤摄取和滞留特性。相较于以177Lu-PSMA为代表的β核素放射性配体疗法，XTR022采用发射α粒子的225Ac作为放射源，具备更高的辐射能量和更短的射程，能够在更精准杀伤肿瘤细胞的同时，最大限度减少对周围正常组织的损伤，具备差异化且更优的治疗潜力。联系方式投资者关系：ir@sinotau.com 商务合作：bd@sinotau.com END 关于先通医药北京先通国际医药科技股份有限公司（简称“先通医药”），始创于2005年，是中国放射性药物市场的领跑者，具备从放射性核素开发及生产、放射性药物研发、制造及商业化的全行业价值链端对端能力。先通医药秉持“做好核药，惠及大众”的使命，立足中国，放眼世界，公司总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物生产基地；同时，在美国设有分支机构。以未满足的临床需求为导向，先通医药重点布局神经退行性疾病、心血管疾病、肿瘤学三大领域，建立了全面、差异化及具有协同效应的产品矩阵，于放射性诊疗一体化方面具有巨大潜力。其中，欧韦宁®为近20年来中国首个获准上市的创新性PET示踪剂；处于不同阶段的多款产品管线广泛覆盖全球放射性药物创新靶点，彰显我们管线的强大竞争力，引领创新放射性药物发展新速度。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确定性及其他因素的影响，有些超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、中国政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本新闻稿所载前瞻性表述之任何义务；及 (b) 倘因任何前瞻性表述不能实现或变成不正确。 ▲滑动查看更多

2026-05-27

·药时空

70 亿美元！核药史上最大并购来袭，Curium 拟收购 Lantheus

2026年5月26日，彭博社援引行业知情人士消息，全球放射性药物龙头企业Curium Pharma向美国同行Lantheus Holdings发起收购邀约，本次交易整体估值高达70亿美元。若交易最终落地，将成为核医学领域年度里程碑式并购，彻底重塑全球放射性药物赛道的竞争格局。截至目前，交易双方均未官方证实本次收购传闻。针对市场传闻，Lantheus官方回应称，企业一贯不对市场谣言及猜测性消息发表评论；Curium则表态，企业会持续评估内生增长与外延并购双重发展路径，全力赋能临床与客户需求，但同样未对本次70亿美元收购事宜作出针对性回应。知情人士透露，现阶段双方尚未签署最终协议，交易仍存在不确定性，若谈判顺利，或将在未来几周内正式官宣。行业整合提速：双方均为赛道高频并购玩家本次并购并非偶然，Curium与Lantheus近年均持续加码外延并购、扩充产业版图，放射性药物行业集中整合趋势愈发凸显。 Curium的核心控股股东为全球知名投资机构CapVest。2025年，CapVest通过延续基金完成对Curium的资本重组，彼时企业估值已达70亿美元。本次资本运作充分印证资本市场对放射性药物赛道的高度认可，行业普遍预判该领域未来15年将迎来指数级增长红利。与此同时，Lantheus在过去一年持续通过精准并购完善研发、生产与管线布局，扩张动作密集且成效显著： 2025年初，Lantheus以2.5亿美元首付款收购放射性药物研发及CDMO龙头企业Evergreen Theragnostics，另设置最高7.525亿美元的业绩里程碑付款。本次收购成功整合Evergreen的规模化生产能力与Lantheus的研发体系，大幅提升企业放射性药物研发、生产一体化能力，同时补齐肿瘤诊断管线布局短板。除此之外，企业先后收购专注阿尔茨海默病PET显像剂研发的Meilleur Technologies、拥有上市F-18 PET显像剂Neuraceq的Life Molecular Imaging，持续夯实自身在神经退行性疾病精准诊断领域的核心竞争优势。业绩稳健增长，核心仿制药即将迎来商业化落地从经营基本面来看，Lantheus整体业绩表现稳健。公司2026年第一季度财报数据显示，当期全球营收达3.773亿美元，营收核心依托三大王牌产品支撑，分别为阿尔茨海默病PET显像剂Neuraceq、超声造影剂Definity以及前列腺癌诊断显像剂Pylarify，产品商业化壁垒稳固、现金流稳定。 Lantheus临时首席执行官Mary Anne Heino在财报电话会议中明确企业发展战略：将精准把控资本投入、优化资源配置，深耕放射诊断核心业务，同时持续挖掘放射治疗资产的商业价值，为企业2027年开启高速增长周期筑牢根基。值得重点关注的是，Lantheus自研的诺华明星药物Lutathera（胃肠胰神经内分泌肿瘤治疗药物）放射性等效仿制药，已于2026年3月斩获FDA暂定批准。制约该产品正式上市的30个月专利禁令将于下月到期，届时这款产品将成为全球首款Lutathera仿制药，有望快速抢占市场，为企业带来可观的新增业绩增量。赛道高景气度延续，放射性药物迎来黄金发展期近年来，依托在肿瘤精准诊断、靶向治疗领域的独特临床价值，放射性药物成为全球医药行业增速最快的细分赛道之一。该类药物通过靶向搭载放射性核素，可同步实现病灶精准显像诊断与肿瘤细胞定向杀伤，是当下精准医疗领域极具发展潜力的核心方向。行业热度持续攀升，产业链配套布局同步提速。就在本周，全球放射性同位素核心供应商Niowave正式启动密歇根州兰辛市新工厂建设，项目总投资7500万美元，将搭载多台超导直线加速器及全套高端质控、生产系统，聚焦规模化量产新一代靶向放射性药物核心原料——锕-225（Ac-225）α发射同位素，精准匹配全球爆发式增长的市场需求。若Curium与Lantheus顺利合并，双方将实现研发技术、产能体系、商业化渠道、管线布局的全方位互补，打造全球核医学领域龙头企业。本次交易的最终落地进展，以及其对全球放射性药物市场格局的重塑影响，值得全行业持续追踪关注。参考来源：https://www.fiercepharma.com/pharma/radiopharma-lantheus-muses-7b-potential-takeover-curium-pharma-bloomberg 识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

并购放射疗法财报

2026-05-26

·FiercePharma

Radiopharmaceutical outfit Lantheus mulls potential $7B takeover by Curium: Bloomberg

Lantheus reported $377.3 million in worldwide revenues over the first quarter of 2026, reflecting sales of its roster of radiodiagnostic imaging agents. A multi-billion-dollar acquisition within the radiopharmaceutical space could be percolating as Lantheus Holding considers a buyout offer from Curium Pharma, Bloomberg reported on Friday. Curium’s proposal values Massachusetts-based Lantheus at about $7 billion, the news outlet said, citing people familiar with the matter. The deal could be weeks away, but a final discussion has not yet been made and no agreement is guaranteed, according to Bloomberg. Lantheus does “not comment on market rumors or speculation” as a matter of policy, a spokesperson told Fierce Pharma on Tuesday. For its part, Curium “operates in a highly competitive environment and, like all companies, is always evaluating organic and external pathways to better serve our patients and customers,” a company representative said in an emailed statement. At the same time, the representative also caveated to Fierce that Curium “does not comment on market rumors or speculation.” Last year, Curium had a hand in what was the “largest transaction in nuclear medicine globally” when its majority owner, global investment firm CapVest, raised money to recapitalize Curium through a new continuation vehicle that similarly valued the radiopharmaceutical company at $7 billion. The investor base that chipped in reflected a “strong belief in the future trajectory of the company in a market poised for exponential growth in the next 15 years,” Curium said at the time. Lantheus, meanwhile, has recently been on the other side of the dealmaking table with an acquisition spree of its own. Early last year, the radiopharmaceutical specialist shelled out $250 million in upfront cash to take on Evergreen Theragnostics, committing up to $752.5 million in additional potential milestone payments. The union of Evergreen’s manufacturing capabilities and infrastructure with Lantheus’ radiopharmaceutical digs was meant to help the company “meet the complex demands of radiopharmaceutical development and production,” Lantheus said, and it also adds new candidates to the company's oncology diagnostic pipeline. Other recent acquisitions for Lantheus include Meilleur Technologies and its Alzheimer’s disease PET imaging agent, plus Life Molecular Imaging and its approved F-18 PET imaging agent Neuraceq, along with broader Alzheimer’s radiodiagnostic commercial infrastructure. While being “disciplined in our capital deployment” and prioritizing radiodiagnostics while weighing the “best path to maximize value from our radiotherapeutic assets,” Lantheus is looking to “lay the groundwork for growth acceleration beginning in 2027,” interim CEO Mary Anne Heino said in the company’s first quarter earnings release. The radiopharma reported $377.3 million in worldwide revenues over the first quarter of 2026, backed largely by Neuraceq, the ultrasound-enhancing agent Definity and the prostate cancer diagnostic imaging agent Pylarify. Meanwhile, next month will see the expiration of a 30-month stay that will allow for approval of Lantheus' radioequivalent version of Novartis’ gastroenteropancreatic neuroendocrine tumor-fighting Lutathera, which the FDA granted a tentative approval in March. Radiopharmaceuticals, or drugs made using small amounts of radioactive material, have quickly risen in popularity. Just last week, radioisotope supplier Niowave broke ground on a new $75 million facility in Lansing, Michigan, that will see multiple superconducting linear accelerators and state-of-the-art processing and quality systems to facilitate the increased production of alpha-emitting isotope Actinium-225 (Ac-225). The class of nuclear medicines can be used in both therapeutic and diagnostic roles.

并购上市批准

100 项与氟[¹⁸F]贝他苯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	氟[¹⁸F]贝他苯	V09AX06	DB09148

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阿尔茨海默症	美国	Lantheus Holdings, Inc.	2014-03-19
认知功能障碍	欧盟	Lantheus Holdings, Inc.	2014-02-20
认知功能障碍	冰岛	Lantheus Holdings, Inc.	2014-02-20
认知功能障碍	列支敦士登	Lantheus Holdings, Inc.	2014-02-20
认知功能障碍	挪威	Lantheus Holdings, Inc.	2014-02-20
诊断试剂	欧盟	Lantheus Holdings, Inc.	2014-02-20
诊断试剂	冰岛	Lantheus Holdings, Inc.	2014-02-20
诊断试剂	列支敦士登	Lantheus Holdings, Inc.	2014-02-20
诊断试剂	挪威	Lantheus Holdings, Inc.	2014-02-20

未上市

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
免疫球蛋白轻链淀粉样变性	临床3期	美国	Lantheus Holdings, Inc.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	德国	Lantheus Holdings, Inc.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	西班牙	Lantheus Holdings, Inc.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	英国	Lantheus Holdings, Inc.	2023-01-13
老年性心脏淀粉样变性	临床3期	美国	Lantheus Holdings, Inc.	2023-01-13
老年性心脏淀粉样变性	临床3期	德国	Lantheus Holdings, Inc.	2023-01-13
老年性心脏淀粉样变性	临床3期	西班牙	Lantheus Holdings, Inc.	2023-01-13
老年性心脏淀粉样变性	临床3期	英国	Lantheus Holdings, Inc.	2023-01-13
转甲状腺素蛋白淀粉样变性心肌病	临床3期	美国	Lantheus Holdings, Inc.	2023-01-13
转甲状腺素蛋白淀粉样变性心肌病	临床3期	德国	Lantheus Holdings, Inc.	2023-01-13

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临床结果

适应症

分期

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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


NCT03706261 (CTgov)	临床1期	阿尔茨海默症	145	18F-Florbetaben+18F-MK-6240	鹹蓋遞糧鑰艱蓋窪鑰夢(鹹範襯蓋鏇醖糧鬱範憲) = 顧鑰壓積衊簾獵範獵繭艱窪艱遞壓鏇製範糧膚 (鏇鏇鏇鑰糧餘餘蓋窪遞, 0.23) 更多	-	2025-08-01
NCT02831283 (CTgov)	临床2期	阿尔茨海默症 \| 炎症	60	11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD))	遞餘廠衊艱鑰艱淵壓選(鑰窪簾築範淵鹽膚衊鹽) = 鏇窪膚遞願糧鑰衊選廠蓋鹹壓淵廠齋膚顧獵齋 (範衊顧淵膚餘淵製壓繭, 0.18) 更多	-	2025-03-05
				11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD))	遞餘廠衊艱鑰艱淵壓選(鑰窪簾築範淵鹽膚衊鹽) = 選醖膚範壓簾齋鬱膚餘蓋鹹壓淵廠齋膚顧獵齋 (範衊顧淵膚餘淵製壓繭, 0.16) 更多
NCT01222351 (CTgov)	N/A	阿尔茨海默症 \| 认知功能障碍	161	BAY 94-9172 (Florbetaben)	鑰壓範醖憲遞壓憲壓繭 = 繭積醖範艱遞糧築衊齋艱鹽醖鬱餘鏇鹽願衊糧 (糧繭齋顧糧獵遞積遞壓, 窪簾衊齋願顧襯淵鹽壓 ~ 鹽遞衊遞積襯顧構壓淵) 更多	-	2024-05-06
NCT03744312 (CTgov)	临床1/2期	阿尔茨海默症 \| 炎症	9	Florbetaben+11C-ER176 (Cognitive Impairment)	艱襯積醖鹹鏇鏇積衊鬱(製繭憲網鏇齋蓋網齋齋) = 襯膚襯糧廠鏇憲壓範觸簾醖願蓋餘顧築鬱蓋憲 (積遞壓構觸願積窪簾鏇, 襯餘艱膚觸膚鹹築遞憲 ~ 鹽膚觸蓋簾鏇遞蓋遞襯) 更多	-	2023-09-13
				Florbetaben+11C-ER176 (No Cognitive Impairment)	艱襯積醖鹹鏇鏇積衊鬱(製繭憲網鏇齋蓋網齋齋) = 餘顧構遞壓夢壓廠簾簾簾醖願蓋餘顧築鬱蓋憲 (積遞壓構觸願積窪簾鏇, 觸膚鬱遞醖膚淵積網憲 ~ 廠襯網醖鑰網製鹽憲鏇) 更多
NCT02681172 (CTgov)	临床4期	阿尔茨海默症	218	florbetaben	衊鬱顧蓋製願積鬱廠觸 = 簾鹹壓構構醖鏇窪鏇範衊鹹網顧廠鏇築夢觸鬱 (顧鹹鏇製網網衊積壓鹹, 淵鑰衊願繭憲餘積選築 ~ 齋憲壓壓壓顧艱繭願糧) 更多	-	2018-11-02
NCT02681172 (AAIC2017)	临床4期	轻度痴呆	205	Florbetaben PET imaging	憲憲鏇憲艱鑰積願繭廠(鬱顧鹹築範餘齋遞糧鹹) = 齋醖窪築壓鏇憲範願簾鬱廠蓋醖餘築淵膚齋餘 (夢鑰壓艱積壓築簾獵繭, 59.9 ~ 73.2) 更多	-	2017-07-01
NCT01020838 (Pubmed \| J Nucl Med)	临床3期	阿尔茨海默症 \| 脑淀粉样血管病	82	18F-Florbetaben (In-person-trained interpreters)	壓觸鹹糧鬱網選簾範範(鏇餘窪鏇糧製鬱襯餘廠) = 淵襯鬱鏇網壓選繭襯鹹鑰壓顧窪襯積鹹鹽鏇積 (觸糧獵齋夢築鬱蓋觸選 ) 更多	-	2016-06-01
				18F-Florbetaben (Electronic training method)	壓觸鹹糧鬱網選簾範範(鏇餘窪鏇糧製鬱襯餘廠) = 壓壓積壓願鑰簾糧糧鑰鑰壓顧窪襯積鹹鹽鏇積 (觸糧獵齋夢築鬱蓋觸選 ) 更多
NCT01020838 (Pubmed \| Alzheimers Dement)	临床3期	阿尔茨海默症 β-amyloid-positive	216	Florbetaben PET imaging	簾鏇鹽鑰廠壓範製範糧(繭顧糧鑰齋糧簾齋選觸) = 選遞淵遞窪衊簾膚選淵齋衊艱繭餘齋膚繭淵簾 (觸憲壓壓衊鏇遞鹽顧願, 93.8 ~ 100) 更多	-	2015-08-01
NCT01138111 (Pubmed \| J Neurol Neurosurg Psychiatry)	临床1期	阿尔茨海默症	45	18F-florbetaben (FBB+)	膚遞簾鏇繭網顧廠鹽網(夢蓋築壓醖夢遞網築淵) = 網蓋鹽繭憲窪構醖淵餘築觸膚憲積鏇繭膚窪壓 (顧觸範艱製窪鹹網築鹹 ) 更多	-	2015-04-01
				18F-florbetaben (FBB-)	製憲積窪衊壓醖簾鏇願(獵醖顧蓋鬱繭製製鹽鏇) = 選願糧鹽蓋築構淵願顧糧製遞醖顧顧衊製鏇襯 (窪餘鏇顧夢鹽選艱構築 )
AAIC2013	N/A	阿尔茨海默症	-	florbetaben (AD patients)	鏇鹹膚齋淵蓋糧糧製壓(廠繭鹹願顧襯鹽網壓鹽) = 糧艱襯構醖遞壓襯鏇範簾繭壓鏇廠膚齋醖襯夢 (遞觸窪簾積膚襯簾襯顧, 0.77 ~ 0.86) 更多	-	2013-07-01
				florbetaben (Healthy volunteers)	願製糧鏇願衊鹹膚簾窪(糧願遞廠網選願積顧獵) = 遞衊選繭範築膚繭鏇壓壓窪繭製醖鹹獵膚廠壓 (壓範糧廠廠願鹹壓齋醖, 73.9 ~ 88.2)