Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

开始日期2023-06-09

申办/合作机构

University of Southern California

[+2]

NCT06141356

/ RecruitingN/AIIT

[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects.
Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.

开始日期2023-01-30

申办/合作机构

北京协和医院

EUCTR2022-002585-33-IT

/ Not yet recruiting临床3期IIT

A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography (PET-CT) - PETAL

开始日期2023-01-19

申办/合作机构

Fondazione Toscana Gabriele Monasterio

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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224

项与氟[¹⁸F]贝他苯相关的文献（医药）

2025-07-01·JACC-Cardiovascular Imaging

Established and Emerging Fluorine-18–Labeled Cardiac PET Radiotracers

Review

作者: Malhotra, Saurabh ; Dilsizian, Vasken ; Packard, René R Sevag ; Pelletier-Galarneau, Matthieu ; Dorbala, Sharmila ; Chen, Wengen

Positron emission tomography (PET)/computed tomography is a major imaging strategy for cardiovascular disease characterization. Whereas multiple radioisotopes can be used for PET imaging of cardiac disease processes, fluorine-18 (¹⁸F) presents key advantages. These include availability as a unit dose given a favorable half-life of 109.7 minutes and a short positron range leading to a high spatial resolution. In this context, there is growing interest in the development of novel ¹⁸F-labeled probes applied to cardiac PET imaging, which in turn provide clinicians with new methods to evaluate disease pathways of interest. Beyond ¹⁸F-fluorodeoxyglucose, used in routine clinical practice to scrutinize myocardial viability, cardiac sarcoidosis, as well as prosthetic valve and cardiac device infection, new ¹⁸F-labeled radiopharmaceuticals have undergone clinical evaluation. These include ¹⁸F-flurpiridaz, which was recently approved by the U.S. Food and Drug Administration for myocardial perfusion imaging and that is also amenable to accurate myocardial blood flow quantitation, ¹⁸F-sodium fluoride to detect metabolically active epicardial coronary atherosclerotic lesions, and the ¹⁸F-labeled amyloid radiotracers florbetapir, flutemetamol, and florbetaben. This review will further explore emerging ¹⁸F-labeled probes applied to cardiac sarcoidosis, myocardial innervation, and ongoing fibrosis/fibroblast activation.

2025-05-04·Journal of Sulfur Chemistry

Small molecule heterocycles: design and synthesis of novel fluorescent Benzothiazoles for early detection of Alzheimer’s disease

作者: Sharma, Vijay ; Sundaram, G.S.M.

Diagnostic agents capable of imaging β-amyloid (Aβ) plaques at prodromal stages could provide noninvasive tools to assess plaque burden and assist in determining efficacy of disease-modifying therapeutic interventions in vivo.To accomplish this goal, FDA approved 18F-incorporated tracers, such as Florbetapir, Flutemetamol, and Florbetaben may allow quant. anal. of therapeutic efficacy of disease-modifying treatments that attenuate Aβ pathophysiol. in vivo.Although promising, these tracers show high off-target binding.Importantly, current anti-amyloid therapy also targets diffuse amyloid plaques (included in revised NIAAA criteria for detecting AD) and other forms of amyloid plaques.Therefore, mols. capable of detecting both diffuse and fibrillar plaque pathol. can potentially offer better quant. tools for interrogating efficacy of anti-amyloid therapy.To achieve this goal, herein, we report synthesis and characterization of new small organic mols.: ((Z,E)-4-(2-(6-(2-Fluoroethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline), ((Z)-4-(2-(6-(2-(2-(3-Fluoropropoxy)ethoxy)ethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline) and ((E)-4-(2-(6-(2-(2-(3-Fluoropropoxy)ethoxy)ethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline) We also report preliminary investigations on binding affinity in vitro.While demonstrated a relatively higher affinity, both and showed moderate affinity for Aβ1-42 aggregates in vitro.Furthermore, all 3 agents showed ability to detect Aβ fibrillar and diffuse plaque pathol. in brain sections of APP/PS1 transgenic mice and post-mortem confirmed AD human brain tissue sections.

2025-04-01·JOURNAL OF ALZHEIMERS DISEASE

Synergistic associations of amyloid-β and phosphorylated tau with tau aggregation and cognitive decline in Alzheimer's disease

Article

作者: Ba, Maowen ; Kong, Min ; Ma, Guozhao ; Jia, Pengyuan ; Zhang, Chunhua ; Tai, Yaojun

Background:

The pathological hallmarks of Alzheimer's disease (AD) include the amyloid-β (Aβ) plaques and phosphorylated tau (p-tau) forming neurofibrillary tangles. Understanding the pathophysiological cascade related to Aβ and tau process is crucial.

Objective:

To investigate the impact of Aβ positron emission tomography (PET) and cerebrospinal fluid (CSF) p-tau on tau pathology and cognitive decline in AD.

Methods:

We analyzed 319 older individuals from the Alzheimer's Disease Neuroimaging Initiative (ADNI) who underwent Aβ ( 18 F-florbetapir or 18 F-florbetaben) and tau ( 18 F-flortaucipir) PET scans, along with CSF and cognitive assessments. Aβ positivity (A+) was determined by global standardized uptake value ratio thresholds of ≥1.11 for 18 F-florbetapir or ≥1.08 for 18 F-florbetaben, while p-tau positivity (T+) was defined as CSF p-tau181 levels ≥23 pg/ml. Linear mixed regression models were used to assess the effects of PET Aβ and CSF p-tau181 levels on tau accumulation in predefined Braak regions and cognitive function over time.

Results:

Our results revealed significant differences in PET tau pathology and cognitive decline between A + and A− individuals. We observed that interactions between Aβ and p-tau proteins were associated with tau accumulation and cognitive decline. Additionally, A−/T + individuals exhibited higher levels of tau accumulation in all Braak regions compared to A−/T− counterparts, suggesting a potential independent role of p-tau in tau pathology in the absence of Aβ.

Conclusions:

Our findings suggest that Aβ positivity and elevated CSF p-tau181 levels were associated with tau accumulation and cognitive decline, highlighting the relevance of soluble p-tau as a potential biomarker for further investigation.

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2025-07-01

·PRNewswire

FDA Expands Indications for Neuraceq®, an Amyloid PET Imaging Agent, to Enhance Diagnosis and Care of Patients with Alzheimer's Disease

New indication added for selection of patients for amyloid-directed therapies Quantitative image analysis added Previous limitations of use removed BOSTON, July 1, 2025 /PRNewswire/ -- Life Molecular Imaging, Ltd. (LMI) announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Neuraceq® (florbetaben F18 injection), expanding its indication for selecting patients for amyloid-targeting therapies, as described in the prescribing information of the therapeutic products, and including the utilization of quantitative analysis for positron emission tomography (PET) scans. Key updates to the Neuraceq® label include: Expanded clinical indication to include use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies. Utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation. Broader use for monitoring of therapy and following progression to Alzheimer's disease (AD). Amyloid, a naturally occurring protein, can accumulate into harmful plaques in the brain, thereby causing AD. Neuraceq® binds selectively to these plaques, enabling detection via PET imaging. This capability assists clinicians in determining whether or not AD is contributing to a patient's cognitive symptoms, when combined with other diagnostic evaluations. This aligns with the prescribing information of FDA approved amyloid-targeting therapeutic products. The clinical studies section now includes that amyloid PET scans have been utilized in certain clinical trials to evaluate reductions in amyloid plaque following treatment with amyloid-targeting therapies. "This FDA action is a major advancement in Alzheimer's diagnostics," said Andrew Stephens, Chief Medical Officer at Life Molecular Imaging. "Updating the Neuraceq® label to reflect the revised Appropriate Use Criteria for amyloid PET1 enhances clinicians' ability to support patient decision making and identify individuals who may benefit from amyloid-targeting treatment - ultimately contributing to improved patient outcomes." The safety profile of Neuraceq® has been confirmed to remain unchanged with the new indication. Neuraceq® PET imaging is widely covered under Medicare and many private insurance plans, although policy specifics can vary. Clinicians and patients are encouraged to verify individual coverage details. About Neuraceq® (florbetaben F 18 injection) Indication (approved by FDA on 23 June 2025) Neuraceq® is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products Important Safety Information Risk for Image Interpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during Neuraceq® image interpretation. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a Neuraceq® scan. Perform image interpretation independently of the patient's clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal. Radiation Risk Neuraceq® contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. Common Adverse Reactions The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of pain (3.4%), erythema (1.7%), and irritation (1.1%). Please see the Full Prescribing Information for Neuraceq® at Neuraceq.com About Life Molecular Imaging (LMI) Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit . LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit . References 1) Rabinovici et al. Updated appropriate use criteria for amyloid and tau PET: A report from the Alzheimer's Association and Society for Nuclear Medicine and Molecular Imaging Workgroup. Alzheimers Dement. 2025 Jan;21(1):e14338. doi: 10.1002/alz.14338 For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

并购放射疗法上市批准

2025-06-12

·PRNewswire

European Commission Grants Orphan Drug Designation to Florbetaben (18F) for Diagnosis of ATTR Amyloidosis

Florbetaben (18F) has been granted Orphan drug designation for the diagnosis of ATTR amyloidosis Florbetaben (18F) previously received orphan drug designation as a diagnostic agent for the management of amyloid light chain (AL) amyloidosis in both the EU and US The efficacy of florbetaben (18F) in diagnosing cardiac amyloidosis is being evaluated in an ongoing multi-center Phase 3 study BERLIN, June 12, 2025 /PRNewswire/ -- Life Molecular Imaging GmbH (LMI) announces today that florbetaben (18F) has been granted orphan designation by the European Commission for the diagnosis of Transthyretin (ATTR) Amyloidosis. Systemic amyloidosis is a rare group of complex diseases caused by protein misfolding and subsequent deposition in tissues, resulting in progressive organ damage. ATTR amyloidosis appears to be the most common form of amyloidosis, with incidence rates rising, likely due to prior underdiagnosis of the disease. Growing awareness of ATTR amyloidosis among cardiologists is improving recognition and diagnosis, allowing patients to access life-saving therapies. Despite the observed rise in the prevalence and incidence of cardiac ATTR amyloidosis – and its high prevalence among patients with heart failure – the overall frequency in the general population remains below the threshold for orphan drug designation (five cases per ten thousand inhabitants of newly diagnosed patients). As a result, EMA granted orphan drug designation to florbetaben (18F) as a diagnostic agent for ATTR amyloidosis. Florbetaben (18F) was initially developed and approved for the detection of neuritic amyloid plaques in the brains of patients with cognitive decline. Preliminary data suggest that florbetaben (18F) may also detect and quantify ATTR amyloid deposits in the heart and other organs using positron emission tomography (PET) imaging, thereby supporting diagnosis of the condition. The current multi-center Phase 3 trial (NCT05184088) aims to further validate florbetaben (18F)'s efficacy in the diagnosis of cardiac amyloidosis, including the ATTR subtype. "The orphan drug designation for florbetaben (18F) will support our efforts to validate this tracer for the diagnosis of both AL and ATTR cardiac amyloidosis. With the approval of several new treatment options, especially for ATTR cardiac amyloidosis, fast and reliable diagnosis of the disease becomes even more important." said Andrew Stephens, MD, PhD, Chief Medical Officer of LMI. About florbetaben (18F) Neuraceq® (florbetaben (18F)) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Neuraceq has been approved for routine clinical use in this indication by FDA, EMA and MHRA, and has local regulatory approval in other countries such as Canada, China, Japan, Korea, Switzerland, Taiwan. Florbetaben (18F) is currently under investigation as a targeted radiopharmaceutical for the detection of amyloid deposits in the heart and other organs of patients with cardiac and systemic amyloidosis of AL and ATTR type. Most Common Adverse Reactions In clinical trials including demented and non-demented subjects, the most frequently observed adverse drug reactions in 872 subjects with 1090 florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%). About Life Molecular Imaging (LMI) Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit . LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit . For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] For scientific information Iris Hardewig | Clinical Development| Life Molecular Imaging Tel. +49 151 14569896| [email protected] UK-Neuraceq-25-00001 SOURCE Life Molecular Imaging WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准孤儿药并购

2025-05-30

·药智网

核药新贵，拟赴港上市

5月，港股创新药可谓热闹非凡。荣昌生物配售融资近8亿元，恒瑞医药、派格生物先后挂牌上市，先通医药也递交了上市申请。先通医药是核药领域新一代龙头企业，其招股书显示，IPO前估值已达51.88亿元，累计融资超29亿元。此次IPO，先通医药有望拓宽融资渠道，加速其核药产品的研发和商业化，也标志着中国核药产业的资本化进程迈出关键一步。四大核心管线过去两年，先通医药营业收入分别为人民币1023.2万和4406.4万元，相应的净亏损分别为人民币3.09亿和1.56亿元。虽然目前处于亏损，但先通医药已建立从放射性核素开发及生产、放射性药物研发到放射性药物的制造及商业化的完整产业链，为未来盈利打下基础。在研发上，先通药业聚焦肿瘤学、神经退行性疾病、心血管疾病三大领域，包括15候选药物，其中两个已上市，四个产品（即XTR008、XTR006、XTR004及XTR003）具备同类首创或同类最佳潜力。图1 先通医药在研管线图片来源：先通医药招股书XTR008是中国潜在首个靶向SSTR的治疗用放射性配体，目前已处于注册阶段。该药是一种177Lu标记生长抑素受体（SSTR）靶向的放射配体，与诺华的畅销药Lutathera靶点相同。而Lutathera为全球唯一获批用于治疗胃肠胰神经内分泌肿瘤（GEP–NENs）的放射性配体疗法，自2018年上市以来，其销售已增长至2024年的7.24亿美元，突破十亿美元指日可待。XTR008的Ⅲ期临床试验显示，其PFS和疗效指标与Lutathera的Ⅲ期NETTER-1试验中观察到的指标相当或更优，具有BIC潜力。XTR006是一种潜在的同类最佳18F标记的微管蛋白相关单元（tau）靶向的PET诊断用放射性配体。该药采用创新分子设计，有效克服已获批PET示踪剂中观察到的脱靶结合问题，从而极大提高特异性和信噪比，提高成像质量及诊断准确性。目前XTR006正在进行一项关于XTR006的Ⅲ期临床试验，并预期于2027年完成该试验。值得注意的是，先通医药的XTR005是中国唯一获批用于AD诊断的病理靶向的PET示踪剂，而XTR006如果也获批，先通医药将同时拥有Aβ及tau靶向PET示踪剂，在AD诊断领域建立市场优势。XTR004是中国首个亦为唯一一个正在临床开发的PET-MPI示踪剂。该药是一种18F标记的线粒体复合体I靶向的诊断用放射性配体，已完成的一期及二期临床试验证明了XTR004极佳的安全性及诊断效果。先通医药计划在2025年第四季度启动Ⅲ期试验。XTR003为全球首个且唯一一个用于心肌脂肪酸代谢成像的PET示踪剂。该药是一种18F标记的PET诊断用放射性配体，已完成XTR003/18F脱氧葡萄糖（「FDG」）结合显像的健康受试者I期临床试验及Ⅱ期临床试验，计划将于2025年启动一项IIb期临床试验。在生产上，先通医药已建成无锡、中山两大生产基地，总建筑面积超2万平方米，设有共计12条商业规模生产线。此外，先通医药在四川省绵阳市的生产基地预计也将于今年开始投产。千亿蓝海市场先通医药此时赴港IPO，既体现了港股市场对创新药的支持，也反映了核药赛道的火热。核药横跨诊断与治疗两大领域，其核心优势在于通过放射性核素标记的靶向分子实现精准诊疗。而近几年诊疗一体化的放射性配体疗法增长迅猛。诺华公司于2017年收购Advanced Accelerator Applications、2018年收购Endocyte，随后在美国市场推出Lutathera和Pluvicto这两款放射性配体疗法。据诺华财报，2024年这两款核药收入达到21.16亿美元，其中Pluvicto销售额达13.92亿美元，上市不到三年即成为重磅炸弹。治疗用放射性配体旨在将靶向辐射直接递送至癌细胞或其他病灶部位。其结构与ADC类似，包含一个靶向配体，可结合靶向细胞上的特定受体或抗原，并与释放细胞毒性辐射的放射性核素偶联。诊断用放射性配体则透过PET或SPECT等成像技术发射可侦测信号。诊疗一体化采用相同或相似结构的靶向配体，同时搭载诊断性与治疗性（如用于疗程的α╱β射线发射体）放射性核素。诊断用放射性配体可先用于肿瘤或病灶的影像定位，再以具有相同或相近结构靶向配体的治疗用放射性配体作为载体，将治疗性辐射精准递送至目标区域。在此模式下，可以实现从诊断到精准治疗的无缝衔接及治疗效果即时监测，并据此调整方案，提升肿瘤整体管理效果。此外，由于放射性配体疗法在机制上与其他治疗手段大不相同，可避免交叉耐药，还可与核治疗、免疫治疗、化疗等其他治疗方式联用。因此，市场对放射性配体疗法寄予厚望，全球并购潮起，跨国药企加速布局核药资产，诺华、BMS、阿斯利康等通过大额并购抢占先机。例如，百时美施贵宝以41亿美元收购尚无上市产品的RayzeBio，凸显市场对核药潜力的高度认可。据先通医药招股书，核药全球市场规模自2018年的50亿美元增至2024年的97亿美元，复合年增长率达11.7%。预估至2035年将攀升至573亿美元，2024至2035年间复合年增长率为17.5%。而中国市场，政策持续加码核医学发展，2021年八部委联合发布了《医用同位素中长期发展规划（2021-2035年）》的文件。随着科学的进展和技术的突破，以及政策的支持，我国核药领域有望迎来爆发期。中国核药产业迎来爆发期当前中国核药市场已形成以中国同辐、东诚药业为主导的双寡头竞争格局。而随着诊疗一体化的放射性配体疗法的崛起，先通药业、远大医药等新锐企业开始崭露头角。远大医药的核药创新药钇[90Y]微球注射液（商品名：易甘泰）于2022年在国内上市，开启了肝部恶性肿瘤治疗的新方向。2022-2024年易甘泰分别实现销售额超过6000万港元、2亿港元和4.9亿港元，呈现了高速放量增长。另外，恒瑞医药、科伦药业、云南白药等老牌大药企也在核药领域也相继取得突破。例如，恒瑞医药的镥[177Lu]氧奥曲肽注射液、HRS-4357注射液和HRS-9815注射液相继获批临床。科伦药业旗下科伦博泰的放射性核素偶联药物SKB107已获NMPA批准晚期实体瘤骨转移临床。云南白药的创新治疗核药INR102的临床试验申请已获得NMPA批准，同意开展前列腺癌的临床试验。先通医药启动IPO进程或将为中国核药产业高质量发展注入强劲动能。若顺利登陆资本市场，其募集资金将用于加速治疗性核药的临床推进及全球化布局。长期来看，随着政策支持、资本投入与技术突破，中国核药市场有望迎来黄金发展期。#先通医药 #IPO #港股打新 #核药 #放射性药物 #放射性配体 #诊疗一体化 #RDC参考来源：1.先通医药招股书2.诺华公司2024年财报3.科伦博泰生物：科伦博泰放射性核素偶联药物（RDC）SKB107 IND获NMPA批准用于治疗晚期实体瘤骨转移4.药智网：恒瑞给了核药市场一个「小震撼」5.云南白药：云南白药集团创新核药INR102注射液I/IIa期临床试验中心启动会在天津顺利召开声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

临床3期放射疗法IPO临床2期

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	Life Molecular Imaging Ltd.	2014-03-19
认知功能障碍	欧盟	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	冰岛	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	挪威	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	欧盟	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	冰岛	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	挪威	Life Molecular Imaging Ltd.	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	Life Molecular Imaging Ltd.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	西班牙	Life Molecular Imaging Ltd.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	英国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	西班牙	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	英国	Life Molecular Imaging Ltd.	2023-01-13
转甲状腺素蛋白淀粉样变性心肌病	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
转甲状腺素蛋白淀粉样变性心肌病	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13

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临床结果

适应症

分期

评价

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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


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))	膚範衊鹽鏇範簾憲糧夢(簾築鹽願獵獵顧醖觸壓) = 範夢製鬱醖衊觸簾鬱憲糧鑰齋積夢選憲夢衊憲 (窪範糧鬱選齋夢夢蓋構, 0.18) 更多	-	2025-03-05
				11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD))	膚範衊鹽鏇範簾憲糧夢(簾築鹽願獵獵顧醖觸壓) = 蓋壓衊製選艱襯蓋齋衊糧鑰齋積夢選憲夢衊憲 (窪範糧鬱選齋夢夢蓋構, 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)	鑰觸築蓋顧廠選繭淵衊 = 鏇淵衊窪蓋窪鏇壓選壓醖網蓋構範鏇蓋膚網製 (鹹鏇廠糧壓壓遞窪範網, 顧築衊鬱齋鏇窪憲顧遞 ~ 襯願鹽鹹願鹽選範選顧) 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)	襯簾齋廠鬱網觸夢鬱鑰(顧繭醖鏇糧顧鏇簾齋餘) = 繭願鏇艱網膚獵鏇蓋顧獵廠觸繭顧壓廠網構遞 (積鹽窪糧網獵淵構範窪, 鑰蓋廠醖築艱顧鏇鬱廠 ~ 鹽獵餘網範襯憲鏇廠構) 更多	-	2023-09-13
				Florbetaben+11C-ER176 (No Cognitive Impairment)	襯簾齋廠鬱網觸夢鬱鑰(顧繭醖鏇糧顧鏇簾齋餘) = 鏇網鹽築廠醖壓選夢範獵廠觸繭顧壓廠網構遞 (積鹽窪糧網獵淵構範窪, 餘衊醖遞範醖遞範簾鹹 ~ 窪淵構觸艱鹹積積鑰範) 更多
SNMMI2023	N/A	阿尔茨海默症	-	18F-Florbetaben (18F-FBB)	鹹鏇選壓築鹹選構觸餘(糧衊艱膚簾鏇醖顧齋廠) = 願廠廠蓋鹹選選簾膚選網鬱構築糧構蓋選繭餘 (遞觸鏇衊窪壓壓製鏇膚, > ~ 1.585) 更多	-	2023-08-28
AMYPAD Diagnostic and Patient Management Study (EANM2022)	N/A	记忆障碍 amyloid burden	729	18f-florbetaben (FBB)	餘製繭獵鑰鹹廠鑰壓鏇(構願簾積艱網製廠膚壓) = 醖遞構鹽壓築鑰餘蓋簾廠簾選壓壓膚襯襯築廠 (糧壓餘範夢顧鬱餘衊顧, 17.87) 更多	-	2022-09-22
				18f-flutemetamol (FTM)	餘製繭獵鑰鹹廠鑰壓鏇(構願簾積艱網製廠膚壓) = 廠淵遞網構夢遞繭簾憲廠簾選壓壓膚襯襯築廠 (糧壓餘範夢顧鬱餘衊顧, 17.87) 更多
EANM2021	N/A	淀粉样蛋白斑 \| 牙周炎	-	18 F-Florbetaben (Absence of periodontal disease or mild periodontitis)	繭蓋鏇簾窪餘糧範繭艱(衊艱選遞獵範壓鏇繭窪) = 鬱夢鏇鑰窪網選鹹鹽繭鹹窪繭襯願構夢壓襯蓋 (憲鑰鹹齋築簾觸夢鑰積 )	-	2021-09-24
SNMMI2021	N/A	阿尔茨海默症 amyloid	264	F18-Florbetaben (Early phase FBB (eFBB))	範襯鏇網願醖衊夢製壓(簾窪簾鹽積鬱艱獵糧網) = 鏇衊衊觸築糧襯觸獵鏇蓋膚憲鏇餘鹹夢遞遞窪 (積鑰願構醖窪鹹鹹廠鏇 )	积极	2021-05-18
				F18-Florbetaben (Delay-phase FBB (dFBB))	範襯鏇網願醖衊夢製壓(簾窪簾鹽積鬱艱獵糧網) = 壓獵衊壓艱窪鹽襯壓淵蓋膚憲鏇餘鹹夢遞遞窪 (積鑰願構醖窪鹹鹹廠鏇 )
SNMMI2020	N/A	淀粉样蛋白斑	-	18 F-Florbetaben (Young Healthy Controls (YHC))	憲範夢鏇繭鑰襯獵齋蓋(鑰鬱簾憲觸糧淵艱積遞) = 憲網獵簾淵繭廠鏇夢遞築壓範醖醖鏇製夢襯獵 (醖鏇鑰鹽鬱膚憲艱廠鹽, 0.03)	-	2020-05-15
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	觸遞遞觸鏇鏇艱鏇艱構(積構蓋築憲鹹築獵衊構) = 窪齋餘觸築齋簾顧醖遞壓鑰願鑰糧憲範淵鹽顧 (觸夢顧襯艱鹽繭選襯鹹, 2.1) 更多
EANM2019	N/A	-	6	[18F]Florbetaben (Standard PET images)	範襯獵蓋蓋遞構顧膚夢(遞積簾艱鹹窪壓淵鏇窪) = 夢築壓齋製蓋獵淵網遞醖鬱範獵衊廠衊膚鹹網 (獵襯築壓窪選憲積鏇簾 ) 更多	-	2019-09-18
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	觸獵築鹽積構鬱觸遞築(鹽餘襯網願遞選鑰積襯) = 醖襯鏇鹽範窪構網鹽憲遞艱廠網醖艱繭衊網簾 (積築壓選製壓繭餘廠鏇 ) 更多
EANM2019	N/A	过氧物酶体病 gene defect \| very long chain fatty acids (VLVFA)	4	[18F]Florbetaben (X-linked adulthood cerebral adrenoleukodystrophy (X-ACALD) patients)	遞鹹鑰夢製衊製願廠糧(醖壓簾襯獵艱遞鑰構築) = 9.8 ± 2.6 衊觸廠糧窪廠廠觸鬱糧 (鑰齋構觸構鏇憲壓鏇製 ) 更多	-	2019-09-18
				[18F]Florbetaben (Healthy control group)