APP inhibitors(Beta amyloid A4 protein inhibitors), TAU inhibitors(Microtubule-associated protein tau inhibitors), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

Nervous System DiseasesOther DiseasesNeoplasms+ [4]

Active Indication

Cognitive DysfunctionAlzheimer DiseaseDiagnostic agents+ [3]

Inactive Indication

Cerebral Amyloid AngiopathyDown SyndromeLewy Body Disease+ [2]

Originator Organization

Piramal Pharma Limited

Active Organization

Life Molecular Imaging Ltd.

Sinotau Pharmaceutical Group

Inactive Organization

Avid Radiopharmaceuticals, Inc.

Eli Lilly & Co.

Drug Highest PhaseApproved

First Approval Date

EU (20 Feb 2014),

Alzheimer DiseaseDiagnostic agents

RegulationOrphan Drug (US), Orphan Drug (EU)

Structure

Molecular FormulaC21H26FNO3

InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N

CAS Registry902143-01-5

Clinical Trials associated with Florbetaben F-18

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

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

National Institute on Aging

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 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.

01 Sep 2023·European journal of nuclear medicine and molecular imaging

Validation of quantitative assessment of florbetaben PET scans as an adjunct to the visual assessment across 15 software methods

Article

Author: Bourgeat, Pierrick ; Lilja, Johan ; Koglin, Norman ; Gómez-González, Juan Pablo ; Bullich, Santiago ; Roé-Vellvé, Núria ; Quintana, Mariana Lagos ; Stephens, Andrew W ; Nelson, Aaron ; Gunn, Roger ; Doré, Vincent ; Whittington, Alex ; Jovalekic, Aleksandar ; Diemling, Markus

Abstract:

Purpose:

Amyloid positron emission tomography (PET) with [18F]florbetaben (FBB) is an established tool for detecting Aβ deposition in the brain in vivo based on visual assessment of PET scans. Quantitative measures are commonly used in the research context and allow continuous measurement of amyloid burden. The aim of this study was to demonstrate the robustness of FBB PET quantification.

Methods:

This is a retrospective analysis of FBB PET images from 589 subjects. PET scans were quantified with 15 analytical methods using nine software packages (MIMneuro, Hermes BRASS, Neurocloud, Neurology Toolkit, statistical parametric mapping (SPM8), PMOD Neuro, CapAIBL, non-negative matrix factorization (NMF), AmyloidIQ) that used several metrics to estimate Aβ load (SUVR, centiloid, amyloid load, and amyloid index). Six analytical methods reported centiloid (MIMneuro, standard centiloid, Neurology Toolkit, SPM8 (PET only), CapAIBL, NMF). All results were quality controlled.

Results:

The mean sensitivity, specificity, and accuracy were 96.1 ± 1.6%, 96.9 ± 1.0%, and 96.4 ± 1.1%, respectively, for all quantitative methods tested when compared to histopathology, where available. The mean percentage of agreement between binary quantitative assessment across all 15 methods and visual majority assessment was 92.4 ± 1.5%. Assessments of reliability, correlation analyses, and comparisons across software packages showed excellent performance and consistent results between analytical methods.

Conclusion:

This study demonstrated that quantitative methods using both CE marked software and other widely available processing tools provided comparable results to visual assessments of FBB PET scans. Software quantification methods, such as centiloid analysis, can complement visual assessment of FBB PET images and could be used in the future for identification of early amyloid deposition, monitoring disease progression and treatment effectiveness.

01 May 2023·Annals of nuclear medicine

Quantitative comparative analysis of amyloid PET images using three radiopharmaceuticals

Article

Author: Kang, Do-Young ; Yoon, Hyun Jin ; Jeong, Young Jin ; Park, Kyung Won

Abstract:

Objective:

Amyloid positron emission tomography (PET) with F-18 florbetaben (FBB), F-18 flutemetamol (FMM), and F-18 florapronol (FPN) is being used clinically for the evaluation of dementia. These radiopharmaceuticals are commonly used to evaluate the accumulation of beta-amyloid plaques in the brain, but there are structural differences between them. We investigated whether there are any differences in the imaging characteristics.

Methods:

A total of 605 subjects were enrolled retrospectively in this study, including healthy subjects (HS) and patients with mild cognitive impairment or Alzheimer’s disease. Participants underwent amyloid PET imaging using one of the three radiopharmaceuticals. The PET images were analyzed visually and semi-quantitatively using a standardized uptake value ratio (SUVR). In addition, we calculated and compared the cut-off SUVR of the representative regions for each radiopharmaceutical that can distinguish between positive and negative scans.

Results:

In the negative images of the HS group, the contrast between the white matter and the gray matter was high in the FMM PET images, while striatal uptake was relatively higher in the FPN PET images. The SUVR showed significant differences across the radiopharmaceuticals in all areas except the temporal lobe, but the range of differences was relatively small. Accuracy levels for the global cut-off SUVR to discriminate between positive and negative images were highest in FMM PET, with a value of 0.989. FBB PET also showed a high value of 0.978, while FPN PET showed a relatively low value of 0.901.

Conclusions:

Negative amyloid PET images using the three radiopharmaceuticals showed visually and quantitatively similar imaging characteristics except in the striatum. Binary classification using the cut-off of the global cortex showed high accuracy overall, although there were some differences between the three PET images.

News (Medical) associated with Florbetaben F-18

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

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06 Feb 2024

·www.prnewswire.com

Life Molecular Imaging and Oryx Isotopes Industrial Company announce a Strategic Partnership for the Production and Distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other countries in reach

Improved supply capabilities of Florbetaben (18F) to provide further access to Amyloid-PET to patients throughout the Middle East and North Africa (MENA) region BERLIN and DAMMAM, Saudia Arabia, Feb. 6, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and Oryx Isotopes Industrial Company (Oryx) have announced a strategic partnership for the production and distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other reachable countries, aiming to enhance the supply of this tracer for Amyloid-PET imaging in the Middle East and North Africa (MENA) region. The partnership grants Oryx the rights to manufacture Florbetaben (18F) at their Dammam production facility and distribute it in Saudi Arabia and nearby regions. Oryx is set to commence manufacturing once the technical setup is finalized. "Establishing this crucial manufacturing and distribution agreement for the production of Florbetaben (18F) will broaden access to Amyloid-PET through our innovative molecular imaging agent for patients in the Middle Eastern Region", said Ludger Dinkelborg, Ph.D., Managing Director at LMI, and added that "the strategic collaboration with Oryx Isotopes will contribute significantly to combating Alzheimer's disease and other causes of cognitive decline." "The collaboration between LMI and Oryx Isotopes will bring excellent opportunities for the Alzheimer's Disease patients in Saudi Arabia and the region to be diagnosed earlier and thus treated with more efficiency. Oryx Isotopes is very enthusiastic for being the first company in GCC to produce F18FBB." Dr. Husain Ahmed (Head of Board) and Dr Aiman Alnahawi (CEO) stated "We are driven by a passion for improving patient care and are dedicated to advancing the field of nuclear medicine through groundbreaking research and the development of novel therapies; definitely our collaboration with LMI will have a significant impact on patients and their relatives quality of life." About Florbetaben (18F)* 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. A negative Florbetaben (18F) 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 Florbetaben (18F) 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. Florbetaben (18F) is an adjunct to other diagnostic evaluations. Most Common Adverse Reactions: In clinical trials, 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%). *Source: US Neuraceq Prescribing Information, Revision 05/2023) 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-centred, 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-centred, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 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, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection. Learn more at About Oryx Isotopes Industrial Company (Oryx) Oryx Isotopes was established in 2021 in the eastern province of Saudi Arabia. The company is proud with its certifications (GMP, ISO9001: 2015, and NRRC) which ensure the quality of products and services and safety of the environment. Oryx Isotopes has emerged from leading companies which have long experiences in the field of radiopharmaceutical production, logistics, nuclear medicine management. It is driven by a set of great values, which are sufficiently reflected in all aspects of the business. Oryx Isotopes aims to enhance the "quality of life" for the patients and this objective will be achievable more with our partnership with LMI. Since its commencement, Oryx Isotopes has grown to be a leading manufacturer for diagnostic and therapeutic radiopharmaceutical. Its powerful presence in the market is built by growing up our loyal customer not only in Saudi Arabia but also in the whole GCC countries. For more information, please visit our website: For media queries Alya Schalabi | Marketing Europe | Life Molecular Imaging Tel#: +49 151 1456 9895 | [email protected] SOURCE Life Molecular Imaging

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09 Jan 2024

·www.prnewswire.com

Life Molecular Imaging and SOFIE announce Neuraceq® availability in Houston

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, Jan. 9, 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 Houston, Texas. The first doses will be available on January 9th, 2023. Continue Reading Life Molecular Imaging (PRNewsfoto/Life Molecular Imaging) 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. It is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases. "With the addition of Houston, TX to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain. We are truly excited about our continued collaboration with SOFIE to provide greater availability of our approved beta-amyloid tracer Neuraceq® to physicians and their patients, and to our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. Patrick Phelps, SOFIE president & CEO states, "After many years of hard work from numerous scientists and clinicians, the recent news in the treatment of Alzheimer's disease seems extremely promising. 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 beta 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 amyloid 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 (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Neuraceq® images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy. Radiation Risk Administration of Neuraceq®, like 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. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Most Common Adverse Reactions In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection site reactions, consisting of erythema (1.7%), injection site irritation (1.1%), and pain (3.4%). About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. 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 38 years' experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT, and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance's distributor of radiopharmaceuticals to diagnose many types of diseases. Visit: About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and high value theragnostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information visit SOFIE's website or contact by email at [email protected] For media queries contact: Brittany Hahn Marketing Communications Manager, Life Molecular Imaging [email protected] Dawn Allen Customer Connections Manager, SOFIE [email protected] SOURCE Life Molecular Imaging

License out/inAcquisition

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
Cognitive Dysfunction	US	Life Molecular Imaging Ltd.	19 Mar 2014
Alzheimer Disease	EU	Life Molecular Imaging Ltd.	20 Feb 2014
Alzheimer Disease	IS	Life Molecular Imaging Ltd.	20 Feb 2014
Alzheimer Disease	LI	Life Molecular Imaging Ltd.	20 Feb 2014
Alzheimer Disease	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)	xnwldobqhi(pryxmsuckc) = klqibprjzl qrtolawunb (rhquemznff, nzffpzqqnq - xenuuslzrd) View more	-	06 May 2024
NCT03744312 (CTgov)	Phase 1/2	Alzheimer Disease \| Inflammation	9	Florbetaben+11C-ER176 (Cognitive Impairment)	wifikikrnh(isgnzgegpo) = mbyphrtutq tisudwqakp (oettvlliuc, mhemoatcxc - cknvripnzw) View more	-	13 Sep 2023
				Florbetaben+11C-ER176 (No Cognitive Impairment)	wifikikrnh(isgnzgegpo) = pxtnmpiuhu tisudwqakp (oettvlliuc, sgsrbmixjg - yedqmxmdbv) View more
AAIC2018	Not Applicable	Mild dementia \| Mild cognitive disorder	152	[F-18] FLORBETABEN (Cognitively Normal)	mjnxggvcnx(jnyvgpapox) = xpmqofcztd vwfexrkouc (auzwkqxljs )	-	01 Jul 2018
				[F-18] FLORBETABEN (Mild Cognitive Impairment)	mjnxggvcnx(jnyvgpapox) = akkkkqoema vwfexrkouc (auzwkqxljs )
AAIC2017	Not Applicable	-	-	18F-FLORBETABEN (MR-based CapAIBL)	cmmnkeacti(tepaoaldjk) = ptfzopiulk wjcxmwsgvk (tgcdtazhch ) View more	-	01 Jul 2017
				18F-FLORBETABEN (MR-less CapAIBL)	cmmnkeacti(tepaoaldjk) = uozanawogt wjcxmwsgvk (tgcdtazhch ) View more
NCT02681172 (AAIC2017)	Phase 4	Mild dementia	205	Florbetaben PET imaging	mxswyjzyom(ilprqbdubw) = mxahplnjkn ljortjkjhp (nzpkzbizqo, 59.9 - 73.2) View more	-	01 Jul 2017
NCT01020838 (Pubmed \| J Nucl Med)	Phase 3	Alzheimer Disease \| Cerebral Amyloid Angiopathy	82	18F-Florbetaben (In-person-trained interpreters)	gumitmkmcw(mzqphdfbqn) = nrhsljvpxm omllwjubhe (tcppyxflce ) View more	-	01 Jun 2016
				18F-Florbetaben (Electronic training method)	gumitmkmcw(mzqphdfbqn) = zjmzwjplct omllwjubhe (tcppyxflce ) View more
P2-12 (CTAD2015)	Not Applicable	neuritic beta-amyloid plaques	78	18F-FLORBETABEN	fdckjccldf(hsaklplxpp) = igshnguspj cleaxkexnp (zxzpsreaeu )	Positive	04 Nov 2015
				18F-FLORBETABEN	fdckjccldf(hsaklplxpp) = tckwwbvqwo cleaxkexnp (zxzpsreaeu )
NCT01020838 (Pubmed \| Alzheimers Dement)	Phase 3	Alzheimer Disease	216	Florbetaben PET imaging	jepkigefpg(qwizmzptfw) = nmpkleswnz jgpsaknvtw (qsalhkdgyg, 93.8 - 100) View more	-	01 Aug 2015
NCT01138111 (Pubmed \| J Neurol Neurosurg Psychiatry)	Phase 1	Alzheimer Disease	45	18F-florbetaben (FBB+)	xffgupjfny(dgijvhfsei) = nkzkfsshqx yyrxieqpzt (ivybwoxzcs ) View more	-	01 Apr 2015
				18F-florbetaben (FBB-)	qogytoimjr(hsbktaxgjx) = dlutyqghsc lvkbncuxkv (kgyahjtbou )
AAIC2014	Not Applicable	Plaque, Amyloid	82	18F-FLORBETABEN (In-person trained readers)	kwdehbdsfg(uwegoyfgrl) = rujcnmoxrj akaetmuyac (eyxoxarxjc ) View more	-	01 Jul 2014
				18F-FLORBETABEN (Electronically trained readers)	kwdehbdsfg(uwegoyfgrl) = zouuyhsuso akaetmuyac (eyxoxarxjc ) View more

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