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.

Start Date09 Jun 2023

Sponsor / Collaborator

University of Southern California

[+2]

NCT06141356

/ RecruitingNot ApplicableIIT

[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.

Start Date30 Jan 2023

Sponsor / Collaborator

Peking Union Medical College Hospital

EUCTR2022-002585-33-IT

/ Not yet recruitingPhase 3IIT

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

Start Date19 Jan 2023

Sponsor / Collaborator

Fondazione Toscana Gabriele Monasterio

100 Clinical Results associated with Florbetaben F-18

100 Translational Medicine associated with Florbetaben F-18

100 Patents (Medical) associated with Florbetaben F-18

224

Literatures (Medical) associated with Florbetaben F-18

01 Jul 2025·JACC-Cardiovascular Imaging

Established and Emerging Fluorine-18–Labeled Cardiac PET Radiotracers

Review

Author: Malhotra, Saurabh ; Pelletier-Galarneau, Matthieu ; Packard, René R Sevag ; Dilsizian, Vasken ; 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.

04 May 2025·Journal of Sulfur Chemistry

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

Author: 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.

01 Apr 2025·JOURNAL OF ALZHEIMERS DISEASE

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

Article

Author: Ba, Maowen ; Ma, Guozhao ; Kong, Min ; 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.

News (Medical) associated with Florbetaben F-18

01 Jul 2025

·www.prnewswire.com

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

AcquisitionRadiation TherapyDrug Approval

12 Jun 2025

·www.prnewswire.com

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

Phase 3Drug ApprovalOrphan DrugAcquisition

20 May 2025

·www.prnewswire.com

Life Molecular Imaging and SOFIE announce Neuraceq® availability in Albany, NY

Improved Neuraceq® supply capabilities to enhance patient access to amyloid PET. BOSTON, May 20, 2025 /PRNewswire/ -- Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE's radiopharmaceutical manufacturing site located near Albany, NY. This agreement results in increased availability of Neuraceq® for imaging centers, physicians, and patients with cognitive impairment in New York, Massachusetts and Vermont among others in the Northeast. The first doses have been made available on May 19th, 2025. Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "At LMI, we are committed to broadening access to Neuraceq® availability for patients and physicians navigating the evaluation of Alzheimer's disease, especially as new treatment options emerge. By expanding our manufacturing capabilities in Albany, NY, through our partnership with SOFIE, we're better positioned to meet the increasing demand for amyloid PET imaging. This initiative reflects our continued dedication to advancing patient access and supporting the healthcare community in the evolving landscape of neurodegenerative care," said Colleen Ruby, US Country Head, and Chief Operating Officer, Americas and APAC. "SOFIE is proud to launch Neuraceq® manufacturing in Albany, NY marking a significant milestone in our mission to advance molecular imaging for Alzheimer's disease. Our facility in Albany, NY bolsters our ability to meet growing demand for advanced Alzheimer's diagnostics and highlights our commitment to support patients and healthcare providers in the Northeast", said William Crisp, PharmD, BCNP SOFIE Vice President, Operations. About Neuraceq® (florbetaben 18F) Indication Neuraceq® 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. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq® have not been established for: - Predicting development of dementia or other neurologic conditions - Monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. Radiation Risk Neuraceq®, similar to other radiopharmaceuticals, 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 handling to protect patients and health care workers from unintentional radiation exposure. 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 erythema (1.7%), irritation (1.1%) and pain (3.4%). For more information please visit: Neuraceq.com About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international 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. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: . For media queries Brittany Hahn, Marketing Communications Manager, Life Molecular Imaging, 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

License out/in

100 Deals associated with Florbetaben F-18

External Link

KEGG	Wiki	ATC	Drug Bank
-	Florbetaben F-18	V09AX06	DB09148

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alzheimer Disease	United States	Life Molecular Imaging Ltd.	19 Mar 2014
Cognitive Dysfunction	European Union	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	Iceland	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	Liechtenstein	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	Norway	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	European Union	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	Iceland	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	Liechtenstein	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	Norway	Life Molecular Imaging Ltd.	20 Feb 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	Phase 3	United States	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	Germany	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	Spain	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	United Kingdom	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	United States	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	Germany	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	Spain	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	United Kingdom	Life Molecular Imaging Ltd.	13 Jan 2023
Transthyretin Amyloid Cardiomyopathy	Phase 3	United States	Life Molecular Imaging Ltd.	13 Jan 2023
Transthyretin Amyloid Cardiomyopathy	Phase 3	Germany	Life Molecular Imaging Ltd.	13 Jan 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02831283 (CTgov)	Phase 2	Alzheimer Disease \| Inflammation	60	11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD))	eixupyfqis(abstagismp) = fomqmhdzhh wovtlgiqvk (xlyuvzuuor, 0.18) View more	-	05 Mar 2025
				11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD))	eixupyfqis(abstagismp) = yhnxmsgfdn wovtlgiqvk (xlyuvzuuor, 0.16) View more
NCT01222351 (CTgov)	Not Applicable	Alzheimer Disease \| Cognitive Dysfunction	161	BAY 94-9172 (Florbetaben)	xwlkqdbtxc = gzzlxrknjw kebjrkatqz (ctwpaeelgw, seoxcfjmac - tpwztwbuvf) View more	-	06 May 2024
NCT03744312 (CTgov)	Phase 1/2	Alzheimer Disease \| Inflammation	9	Florbetaben+11C-ER176 (Cognitive Impairment)	mfvxnabjjg(eldixzttdc) = cgomkhzwlo nvlhbivfyq (tmluvbztzp, gfuhmudefe - jjfsdxusxk) View more	-	13 Sep 2023
				Florbetaben+11C-ER176 (No Cognitive Impairment)	mfvxnabjjg(eldixzttdc) = ocymgpevwx nvlhbivfyq (tmluvbztzp, lapkcccwus - vibyjpjvfu) View more
SNMMI2023	Not Applicable	Alzheimer Disease	-	18F-Florbetaben (18F-FBB)	dcsjnhzykj(zkkyracnyk) = gdijdrrgli xxvhzplgzb (njtfvyhysu, > - 1.585) View more	-	28 Aug 2023
AMYPAD Diagnostic and Patient Management Study (EANM2022)	Not Applicable	Memory Disorders amyloid burden	729	18f-florbetaben (FBB)	lfvhmkxvmg(afdqbyibzl) = ybhtiixpne txtggffbel (tjlkbwrpoh, 17.87) View more	-	22 Sep 2022
				18f-flutemetamol (FTM)	lfvhmkxvmg(afdqbyibzl) = inhcpecnni txtggffbel (tjlkbwrpoh, 17.87) View more
EANM2021	Not Applicable	Plaque, Amyloid \| Periodontitis	-	18 F-Florbetaben (Absence of periodontal disease or mild periodontitis)	kgdupjefsg(siewvprjlr) = fnnpocvqpk cepwzmilrn (kszsfdziwj )	-	24 Sep 2021
SNMMI2021	Not Applicable	Alzheimer Disease amyloid	264	F18-Florbetaben (Early phase FBB (eFBB))	giceifvpzg(okusjeenud) = qzhjwufogn iaiolalsvb (qxaakcphwr )	Positive	18 May 2021
				F18-Florbetaben (Delay-phase FBB (dFBB))	giceifvpzg(okusjeenud) = sdcdikfxlp iaiolalsvb (qxaakcphwr )
SNMMI2020	Not Applicable	Plaque, Amyloid	-	18 F-Florbetaben (Young Healthy Controls (YHC))	tktkevhhth(qczloomwfn) = ctxeybkmmd upuoexmsto (tzvwirqqld, 0.03)	-	15 May 2020
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	ergdqzwbkf(asmazplujq) = dwibweaoti qgqewmpgbf (hywifuhjiu, 2.1) View more
EANM2019	Not Applicable	Peroxisomal Disorders gene defect \| very long chain fatty acids (VLVFA)	4	[18F]Florbetaben (X-linked adulthood cerebral adrenoleukodystrophy (X-ACALD) patients)	iyuydkordi(cfrpcpxhoj) = 9.8 ± 2.6 ahbwtfgxip (angsfzoteq ) View more	-	18 Sep 2019
				[18F]Florbetaben (Healthy control group)
EANM2019	Not Applicable	-	6	[18F]Florbetaben (Standard PET images)	vnqwrjfzmd(czwxqplhdj) = ahzvszzysn qqjvoblzua (emjuewcjzs ) View more	-	18 Sep 2019
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	jsmlvdjhjg(nquhaczsvh) = ghxkoifscj nhpcspwbjb (hfvqbhltkl ) View more

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