[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

NCT05184088 / RecruitingPhase 3

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.

Start Date13 Jan 2023

Sponsor / Collaborator

Life Molecular Imaging Ltd.

[+1]

NCT05361382 / RecruitingPhase 1IIT

Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

Start Date23 Nov 2021

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Florbetaben F-18

100 Translational Medicine associated with Florbetaben F-18

100 Patents (Medical) associated with Florbetaben F-18

Literatures (Medical) associated with Florbetaben F-18

01 Aug 2024·Alzheimers & Dementia

Florbetaben amyloid PET acquisition time: Influence on Centiloids and interpretation

Article

Author: Carlson, Mackenzie L. ; Mormino, Elizabeth C. ; Vossler, Hillary A. ; Zeineh, Michael ; Landau, Susan ; Harrison, Theresa M. ; Sha, Sharon J. ; Young, Christina B. ; Zaharchuk, Greg ; Wagner, Anthony ; Davidzon, Guido A. ; Rathmann‐Bloch, Julia ; Poston, Kathleen L. ; Johns, Emily ; Smith, Viktorija ; Henderson, Victor ; Winer, Joseph R. ; Park, Jennifer ; Younes, Kyan

Abstract:

INTRODUCTION:

Amyloid positron emission tomography (PET) acquisition timing impacts quantification.

METHODS:

In florbetaben (FBB) PET scans of 245 adults with and without cognitive impairment, we investigated the impact of post‐injection acquisition time on Centiloids (CLs) across five reference regions. CL equations for FBB were derived using standard methods, using FBB data collected between 90 and 110 min with paired Pittsburgh compound B data. Linear mixed models and t‐tests evaluated the impact of acquisition time on CL increases.

RESULTS:

CL values increased significantly over the scan using the whole cerebellum, cerebellar gray matter, and brainstem as reference regions, particularly in amyloid‐positive individuals. In contrast, CLs based on white matter–containing reference regions decreased across the scan.

DISCUSSION:

The quantification of CLs in FBB PET imaging is influenced by both the overall scan acquisition time and the choice of reference region. Standardized acquisition protocols or the application of acquisition time–specific CL equations should be implemented in clinical protocols.

Highlights:

Acquisition timing affects florbetaben positron emission tomography (PET) scan quantification, especially in amyloid‐positive participants.The impact of acquisition timing on quantification varies across common reference regions.Consistent acquisitions and/or appropriate post‐injection adjustments are needed to ensure comparability of PET data.

02 Jul 2024·Chembiochem : a European journal of chemical biology

Role of Amyloidogenic and Non‐Amyloidogenic Protein Spaces in Neurodegenerative Diseases and their Mitigation Using Theranostic Agents

Review

Author: Gupta, Vishakha ; Murugan, N. Arul ; Kumar, Virendra ; Ramesh, Madhu ; Suri, Kapali ; Govindaraju, Thimmaiah ; Bhandari, Mansi

Abstract:

Neurodegenerative diseases (NDDs) refer to a complex heterogeneous group of diseases which are associated with the accumulation of amyloid fibrils or plaques in the brain leading to progressive loss of neuronal functions. Alzheimer's disease is one of the major NDD responsible for 60–80 % of all dementia cases. Currently, there are no curative or disease‐reversing/modifying molecules for many of the NDDs except a few such as donepezil, rivastigmine, galantamine, carbidopa and levodopa which treat the disease‐associated symptoms. Similarly, there are very few FDA‐approved tracers such as flortaucipir (Tauvid) for tau fibril imaging and florbetaben (Neuraceq), flutemetamol (Vizamyl), and florbetapir (Amyvid) for amyloid imaging available for diagnosis. Recent advances in the cryogenic electron microscopy reported distinctly different microstructures for tau fibrils associated with different tauopathies highlighting the possibility to develop tauopathy‐specific imaging agents and therapeutics. In addition, it is important to identify the proteins that are associated with disease development and progression to know about their 3D structure to develop various diagnostics, therapeutics and theranostic agents. The current article discusses in detail the disease‐associated amyloid and non‐amyloid proteins along with their structural insights. We comprehensively discussed various novel proteins associated with NDDs and their implications in disease pathology. In addition, we document various emerging chemical compounds developed for diagnosis and therapy of different NDDs with special emphasis on theranostic agents for better management of NDDs.

01 Feb 2024·European Journal of Nuclear Medicine and Molecular Imaging

Impact of simulated reduced injected dose on the assessment of amyloid PET scans

Article

Author: Barkhof, Frederik ; Perissinotti, Andrés ; Young, Peter ; Hitzel, Anne ; Baker, Suzanne ; Lubberink, Mark ; Niñerola-Baizan, Aida ; Collij, Lyduine E ; Farrar, Gill ; Gispert, Juan Domingo ; Schöll, Michael ; Zaidi, Habib ; Garibotto, Valentina ; Heeman, Fiona ; Sanaat, Amirhossein ; Frisoni, Giovanni B ; Rieckmann, Anna ; Axelsson, Jan

Abstract:

Purpose:

To investigate the impact of reduced injected doses on the quantitative and qualitative assessment of the amyloid PET tracers [18F]flutemetamol and [18F]florbetaben.

Methods:

Cognitively impaired and unimpaired individuals (N = 250, 36% Aβ-positive) were included and injected with [18F]flutemetamol (N = 175) or [18F]florbetaben (N = 75). PET scans were acquired in list-mode (90–110 min post-injection) and reduced-dose images were simulated to generate images of 75, 50, 25, 12.5 and 5% of the original injected dose. Images were reconstructed using vendor-provided reconstruction tools and visually assessed for Aβ-pathology. SUVRs were calculated for a global cortical and three smaller regions using a cerebellar cortex reference tissue, and Centiloid was computed. Absolute and percentage differences in SUVR and CL were calculated between dose levels, and the ability to discriminate between Aβ- and Aβ + scans was evaluated using ROC analyses. Finally, intra-reader agreement between the reduced dose and 100% images was evaluated.

Results:

At 5% injected dose, change in SUVR was 3.72% and 3.12%, with absolute change in Centiloid 3.35CL and 4.62CL, for [18F]flutemetamol and [18F]florbetaben, respectively. At 12.5% injected dose, percentage change in SUVR and absolute change in Centiloid were < 1.5%. AUCs for discriminating Aβ- from Aβ + scans were high (AUC ≥ 0.94) across dose levels, and visual assessment showed intra-reader agreement of > 80% for both tracers.

Conclusion:

This proof-of-concept study showed that for both [18F]flutemetamol and [18F]florbetaben, adequate quantitative and qualitative assessments can be obtained at 12.5% of the original injected dose. However, decisions to reduce the injected dose should be made considering the specific clinical or research circumstances.

News (Medical) associated with Florbetaben F-18

29 Oct 2024

·www.prnewswire.com

Life Molecular Imaging and PharmaLogic announce Neuraceq® availability in Cincinnati, OH

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, Oct. 29, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announce their strategic partnership to provide and distribute Neuraceq® from PharmaLogic's radiopharmaceutical manufacturing site located in Cincinnati, OH. The first doses were made available on October, 24th, 2024. Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease 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. "LMI is dedicated to focusing our activities on broadening Neuraceq® market access for patients and physicians who are seeking confirmation of beta-amyloid plaque in the brain, notably for individuals who may be eligible for therapeutics. Expanding Neuraceq® manufacturing in Cincinnati, OH, in collaboration with PharmaLogic, further reinforces our commitment to meeting the increased market demand for patient access to amyloid PET imaging with Neuraceq®. We are proud to support the medical and patient communities in this area," said Colleen Ruby, US Country Head, and Chief Operating Officer, Americas and APAC. James Beatty, VP of Development and Commercialization for PharmaLogic, highlighted the value of this partnership: "Our collaboration with Life Molecular Imaging enhances our ability to support the adoption of newly approved novel therapies for Alzheimer's disease by enabling a broad and reliable access to beta-amyloid PET providing these necessary diagnostics. Together, PharmaLogic is committed to delivering advanced diagnostic solutions that meet the needs of patients and clinicians in the Cincinnati, OH region." 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 pharma 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 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

09 Jul 2024

·www.prnewswire.com

Life Molecular Imaging and Jubilant Radiopharma announce Neuraceq® availability in Mobile, AL

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, July 9, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and Jubilant Radiopharma, a global company that offers radiopharmaceuticals and radiopharmacies for nuclear medicine, announce the expansion of their strategic partnership and licensing agreement to provide and distribute Neuraceq® from Jubilant's single photon emission computed tomography (SPECT) and Positron Emision Tomography (PET) radiopharmaceutical manufacturing site located in Mobile, AL. The first doses have been made available on July 9th, 2024. Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "Expanding Neuraceq® manufacturing in Mobile in collaboration with Jubilant, further reinforces Life Molecular Imaging's commitment to meeting the increasing demand for amyloid detection to confirm eligibility for new therapies. We are excited to support the growing needs of the customers in the region, and to provide Neuraceq® access for the benefit of physicians, patients, and our pharma partners," said Colleen Ruby, US Country and Chief Operating Officer, Americas and APAC. "More than 6.2 million Americans are currently living with Alzheimer's disease. A progressive brain disorder that impacts memory, thinking and language skills, and the ability to carry out the simplest tasks. The Jubilant Radiopharma Team is excited to bring Neuraceq® to physicians and patients in the Mobile, AL area," said Renato Leite, President, Jubilant Radiopharmacies. "The availability of Neuraceq® offers new hope through the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease." 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 pharma 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: | About Jubilant Radiopharma Jubilant Radiopharma, a division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business that comprises development, manufacturing and commercialization of products through its Radiopharmaceuticals business and distribution through its national network of Radiopharmacies. The division's Radiopharmacies business is the second largest radiopharmacy network in the US with 46 pharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals. This business has over 30 years of experience in serving the US nuclear medicine community and its current geographical reach enables it to serve over four million patients yearly. Jubilant Radiopharma is focused on "Improving Lives through Nuclear Medicine". For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging

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05 Apr 2024

·www.prnewswire.com

Life Molecular Imaging and SOFIE announce Neuraceq® availability in Cleveland

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, April 5, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) 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 in Cleveland, Ohio. The first doses have been made available on April 4, 2024. Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "By adding Cleveland to our distribution network, Life Molecular Imaging is thrilled to provide additional availability of Neuraceq®, an important imaging tool for the detection of beta-amyloid plaques in the brain. Our continued collaboration with SOFIE provides greater availability of our approved beta-amyloid tracer Neuraceq®. We believe this additional access to Neuraceq® benefits physicians and patients, as well as our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. Brian Schumer, PharmD, SOFIE COO states, "We are excited to bring Neuraceq® availability to another SOFIE network site. The continued growth and advancement in Alzheimer's disease diagnosis and treatment is very promising for patients and their families. SOFIE is committed to the further expansion and availability of LMI's Neuraceq® PET diagnostic tracer throughout our national PET manufacturing and dispensing network." 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 pharma 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 Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging

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.

to view more data

Indication	Country/Location	Organization	Date
Alzheimer Disease	US	Life Molecular Imaging Ltd.	19 Mar 2014
Cognitive Dysfunction	EU	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	IS	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	LI	Life Molecular Imaging Ltd.	20 Feb 2014
Cognitive Dysfunction	NO	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	EU	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	IS	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	LI	Life Molecular Imaging Ltd.	20 Feb 2014
Diagnostic agents	NO	Life Molecular Imaging Ltd.	20 Feb 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Amyloid Neuropathies, Familial	Phase 3	US	Life Molecular Imaging Ltd.	13 Jan 2023
Amyloid Neuropathies, Familial	Phase 3	DE	Life Molecular Imaging Ltd.	13 Jan 2023
Amyloid Neuropathies, Familial	Phase 3	ES	Life Molecular Imaging Ltd.	13 Jan 2023
Amyloid Neuropathies, Familial	Phase 3	GB	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	US	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	DE	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	ES	Life Molecular Imaging Ltd.	13 Jan 2023
Immunoglobulin Light-Chain Amyloidosis	Phase 3	GB	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	US	Life Molecular Imaging Ltd.	13 Jan 2023
Senile cardiac amyloidosis	Phase 3	DE	Life Molecular Imaging Ltd.	13 Jan 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01222351 (CTgov)	Not Applicable	Alzheimer Disease \| Cognitive Dysfunction	161	BAY 94-9172 (Florbetaben)	fpfhyhaggg(lsjnguceae) = sbphdymmio cbiwjtncij (tmxnexsnpl, hggadhthvy - qanukkxrdy) View more	-	06 May 2024
NCT03744312 (CTgov)	Phase 1/2	Alzheimer Disease \| Inflammation	9	Florbetaben+11C-ER176 (Cognitive Impairment)	tgunmamreo(guytqvwqyf) = jcbazoogbd jlmfamavdr (ovgxzxdeax, ygcmslvusa - xfvpwsxogz) View more	-	13 Sep 2023
				Florbetaben+11C-ER176 (No Cognitive Impairment)	tgunmamreo(guytqvwqyf) = iugwzjdpwt jlmfamavdr (ovgxzxdeax, lrxazgvqqk - ubvkfhtfgp) View more
SNMMI2023	Not Applicable	Alzheimer Disease	-	18F-Florbetaben (18F-FBB)	lplhtjtsst(eospvmdzum) = tagvbkyphz zdxgnlhlli (faeyxorbfn, > - 1.585) View more	-	28 Aug 2023
AMYPAD Diagnostic and Patient Management Study (EANM2022)	Not Applicable	Memory Disorders amyloid burden	729	18f-florbetaben (FBB)	ygicfgwreg(nknpohvqsm) = oynwtulubz snzgtaulfc (jhpaggetrs, 17.87) View more	-	22 Sep 2022
				18f-flutemetamol (FTM)	ygicfgwreg(nknpohvqsm) = iqclltqmml snzgtaulfc (jhpaggetrs, 17.87) View more
EANM2021	Not Applicable	Plaque, Amyloid \| Periodontitis	-	18 F-Florbetaben (Absence of periodontal disease or mild periodontitis)	bcofpropkk(evkmwldnqb) = ddaafwishe nhcxsonffa (ccllvsdceu )	-	24 Sep 2021
SNMMI2020	Not Applicable	Plaque, Amyloid	-	18 F-Florbetaben (Young Healthy Controls (YHC))	pvsvtcnvsf(nowjeowqvk) = sgooqoneeu lgcwrzwydm (ohafqetnyl, 0.03)	-	15 May 2020
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	obpwjhxasg(nhurpowart) = lfkfnhcokw vcmxdoiyzk (zgqmerstka, 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)	sqofohgxvk(lxhxbclhjv) = 9.8 ± 2.6 cllccdnwvo (tyozsknfrh ) View more	-	18 Sep 2019
				[18F]Florbetaben (Healthy control group)
EANM2019	Not Applicable	-	6	[18F]Florbetaben (Standard PET images)	iroeobgsaq(ybdpstfuxa) = mxudvbnluw ppipslbbbh (iabcjnknaw ) View more	-	18 Sep 2019
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	jlhhgvqybq(eddsykuuuy) = vtzorfhexn ahbqqtjysp (jqqylaffrl ) View more
EANM2018	Not Applicable	-	44	18F-Florbetaben (Amyloid-PET)	luvqefvzex(ltjgdbzsel) = dmsfedivel riqpczecad (nwcnchbsvn )	Positive	18 Sep 2018
AAIC2018	Not Applicable	Mild dementia \| Mild cognitive disorder ApolipoproteinE (APOE) genotype	152	[F-18] FLORBETABEN (Cognitively Normal)	mmravwiwvi(hrisrbhnal) = umxukzmvtd udeppljcri (djomnuyazm )	-	01 Jul 2018
				[F-18] FLORBETABEN (Mild Cognitive Impairment)	mmravwiwvi(hrisrbhnal) = zhdfhazlop udeppljcri (djomnuyazm )

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