[Translation] A phase 1 non-randomized, non-comparative, open-label study to evaluate the safety, biodistribution, and internal radiation dose of a single-dose DaTSCAN iodine [123I] flupan injection in healthy Chinese volunteers

经过与药品审评中心的沟通交流，进行一项在中国健康志愿者中评估单剂量DaTSCAN碘[123I]氟潘注射液的安全性、生物分布和内辐射剂量的1期非随机、非比较性、开放性研究

[Translation]

After communication with the Center for Drug Evaluation, a Phase 1 non-randomized, non-comparative, open-label study was conducted to evaluate the safety, biodistribution, and internal radiation dose of a single dose of DaTSCAN iodine [123I] flupan injection in healthy Chinese volunteers

Start Date14 May 2021

Sponsor / Collaborator

GE Healthcare B.V.

[+2]

NCT04564092 / CompletedPhase 1

A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers

This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.

Start Date13 May 2021

Sponsor / Collaborator

GE Healthcare Holdings, Inc.

[+1]

EUCTR2019-000247-27-FR / Unknown statusPhase 3

Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP

Start Date31 Mar 2021

Sponsor / Collaborator

Zionexa

100 Clinical Results associated with Ioflupane-I-123

100 Translational Medicine associated with Ioflupane-I-123

100 Patents (Medical) associated with Ioflupane-I-123

233

Literatures (Medical) associated with Ioflupane-I-123

01 Feb 2024·Radiographics : a review publication of the Radiological Society of North America, Inc

Practical Overview of ¹²³I-Ioflupane Imaging in Parkinsonian Syndromes

Article

Author: Wilson, Shannon ; Mercer, Megan K ; Lewis, David H ; Kuo, Phillip H ; Elojeimy, Saeed ; Johnson, Lester S ; Banks, Kevin P ; Revels, Jonathan W ; Blacklock, Lisa C

Parkinsonian syndromes are a heterogeneous group of progressive neurodegenerative disorders involving the nigrostriatal dopaminergic pathway and are characterized by a wide spectrum of motor and nonmotor symptoms. These syndromes are quite common and can profoundly impact the lives of patients and their families. In addition to classic Parkinson disease, parkinsonian syndromes include multiple additional disorders known collectively as Parkinson-plus syndromes or atypical parkinsonism. These are characterized by the classic parkinsonian motor symptoms with additional distinguishing clinical features. Dopamine transporter SPECT has been developed as a diagnostic tool to assess the levels of dopamine transporters in the striatum. This imaging assessment, which uses iodine 123 (¹²³I) ioflupane, can be useful to differentiate parkinsonian syndromes caused by nigrostriatal degeneration from other clinical mimics such as essential tremor or psychogenic tremor. Dopamine transporter imaging plays a crucial role in diagnosing parkinsonian syndromes, particularly in patients who do not clearly fulfill the clinical criteria for diagnosis. Diagnostic clarification can allow early treatment in appropriate patients and avoid misdiagnosis. At present, only the qualitative interpretation of dopamine transporter SPECT is approved by the U.S. Food and Drug Administration, but quantitative interpretation is often used to supplement qualitative interpretation. The authors provide an overview of patient preparation, common imaging findings, and potential pitfalls that radiologists and nuclear medicine physicians should know when performing and interpreting dopamine transporter examinations. Alternatives to ¹²³I-ioflupane imaging for the evaluation of nigrostriatal degeneration are also briefly discussed. ^©RSNA, 2024 Test Your Knowledge questions for this article are available in the supplemental material. See the invited commentary by Intenzo and Colarossi in this issue.

01 Feb 2024·Nuclear medicine communications

Should we reconsider blocking the thyroid for 123I-Ioflupane studies in elderly patients: quantifying radiation dose to the unblocked thyroid and implications for clinical practice

Article

Author: Vennart, Nicholas ; Gannon, Mark ; Morton, D William A ; Bartholomew, Peter ; Razvi, Salman ; Slinger, Harry

Objectives:

To measure the absorbed dose to the thyroid in patients injected with 123I-Ioflupane where the thyroid was not blocked with prophylaxis to investigate whether thyroid blocking should be limited to younger patients. This risk from the additional absorbed dose to the thyroid was then compared to the risk from iodine overdose through ingestion of the iodide prophylaxis, resulting in iodine-induced hyper/hypothyroidism (IIH).

Methods:

A cohort of patients (n = 30) who did not receive thyroid prophylaxis underwent static thyroid imaging 3 h after 123I-Ioflupane administration. The measured thyroidal uptake of free 123I was then extrapolated to peak uptake time (24 h post-administration). This value was used to calculate cumulated activity in the thyroid and thus thyroid-thyroid absorbed dose D(r thy ←r thy ) using the relevant S-value in the MIRD method.

Results:

Mean D(r thy ←r thy ) was found to be 13.6 mGy with an SD of 8.8 mGy; this would contribute an additional 0.5 mSv to the effective dose.

Conclusion:

ARSAC recommends in its Notes for Guidance prophylactic thyroid blocking if the absorbed dose to the thyroid is >50 mGy; the maximum thyroid dose in this study cohort was 36.3 mGy. With risk from IIH and its associated cardiac complications increasing with age, this study suggests that iodide prophylaxis with 123I-Ioflupane should be reconsidered for elderly patient.

01 Jan 2024·Clinical neuropharmacology

Marked Decreased Tracer Binding in 123I-FP-CIT SPECT Scans From Lisdexafetamine Dismesylate Interaction: A Case Report

Article

Author: Lowe, Val ; Boeve, Bradley F ; Kantarci, Kejal ; Miyagawa, Toji ; Vernon, Cynthia ; Min, Hoon-Ki ; Fields, Julie A ; Przybelski, Scott A

Objectives:

The objective of this case study is to raise awareness of potential 123I-FP-CIT SPECT interference by lisdexafetamine dimesylate, a prodrug of d-amphetamine.

Methods:

A 69-year-old man with Rapid Eye Movement sleep behavior disorder and mild cognitive impairment had been treated with lisdexafetamine dimesylate for attention-deficit/hyperactivity disorder. The patient had annual or biennial 123I-FP-CIT SPECT evaluations after their baseline visit at 69 years old. Nigrostriatal dopamine transporter uptake was semiquantitatively evaluated with 123I-FP-CIT SPECT using DaTQUANT 2.0 software. Lisdexafetamine dimesylate was discontinued 3 months before the sixth-year visit (76 years old) by his primary care provider.

Results:

The patient had 4 123I-FP-CIT SPECT scans with lisdexafetamine dimesylate and 2 scans after the discontinuation of lisdexafetamine dimesylate. The DaTQUANT z-scores of the putamen declined from −1.36 at the baseline visit to −3.02 at the fifth-year visit. After the discontinuation of lisdexafetamine dimesylate, DaTQUANT z-scores of the putamen increased to −0.63 at the sixth-year visit and remained in the normal range of −0.71 at the seventh-year visit.

Conclusions:

This case suggests that lisdexafetamine dimesylate may have a strong interference with 123I-FP-CIT SPECT, decreasing the tracer binding to the dopamine transporter and presenting false positive results.

News (Medical) associated with Ioflupane-I-123

06 Feb 2024

·www.biospace.com

Curium Announces Ioflupane I 123 Injection Availability for Friday Patient Use

ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024. This expansion in capacity should help address a growing need for SPECT brain imaging. Approximately 90,000 people in the US each year are diagnosed with Parkinson’s1 and nearly 1.24 million will be diagnosed by 20302. Additionally, one in four patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease3. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease4. Robert Burke, North American Senior Vice President of Commercial at Curium, commented: “Curium’s expanded capacity on Fridays will allow our customers and their patients greater scheduling flexibility. Our customers have asked for this expansion and Curium is thrilled to be able to satisfy this request. We look forward to launching Friday patient use on April 5.” About Ioflupane I 123 Injection INDICATION AND USE Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Important Risk Information CONTRAINDICATIONS Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to Ioflupane I 123. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration. Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection. Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. ADVERSE REACTIONS In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established. USE IN SPECIFIC POPULATIONS Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection. Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant. Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients. Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies. Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images. OVERDOSAGE The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. Please see full Prescribing Information by clicking here or visit References: 1 Willis AW, Roberts E, Beck JC, et al. “Incidence of Parkinson disease in North America.” NPJ Parkinsons Disease. 2022;8:170. 2 Marras C, Beck JC, Bower JH, et al. “Prevalence of Parkinson’s disease across North America.” NPJ Parkinsons Disease. 2018;4:21. doi:10.1038/s41531-018-0058-0 3 Barker, Warren W, Luis, Cheryl A, Kashuba A, et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer Disease and Associated Disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001 4 Warr L, Walker Z. “Identification of biomarkers in Lewy-body disorders.” Quarterly Journal of Nuclear Med Mol Imaging; 2012; 56: 39-54 About Curium Curium is a world leader in nuclear medicine. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Ross Bethell ross.bethell@curiumpharma.com or +44.7827.833.176.

Radiation TherapyDiagnostic ReagentsClinical Study

24 Jan 2024

·www.pmlive.com

New framework establishes two tests for use in clinical trials for Parkinson’s

A new framework has been established by leading scientists and patient organisations for using two tests to improve clinical trials for identifying Parkinson’s disease (PD). Affecting around 145,000 people in the UK, PD is a progressive neurological condition that affects the brain, causing symptoms such as shaking and stiffness. The new staging framework, published in The Lancet , proposes how two important medical tests could be used in clinical trials of new treatments for Parkinson’s, as well as other related conditions, and have been selected for their ability to identify key biological features of the disease. The framework involved experts from the Center for Drug Evaluation and Research, the Michael J Fox Foundation for Parkinson’s Research, Swiss pharmaceutical company Roche, Parkinson’s UK and Cure Parkinson’s. A major challenge faced within clinical trials for PD is that most diagnoses are based on symptoms, which can differ from person to person. By having tests that can identify what exactly is occurring inside the brain, clinical trials for PD will be more able to select the right participants and will be better able to measure the potential of the treatment under investigation. The first test selected can identify misfolded alpha-synuclein, a protein that is a hallmark of PD, from fluid taken from the spine via a lumbar puncture test. The second test is a brain scan known as DaTSCAN, which can identify whether there is a lack of dopamine, a chemical that progressively decreases over time in PD, within the brain. Both tests identify people who are in the early stages of the disease before obvious symptoms emerge. Ultimately, this will speed up the development of therapies that can stop the loss of brain cells in the disease, which, at present, no treatments have achieved. Helen Matthews, chief executive officer at Cure Parkinson's, commented: “Adding precision to our clinical trials is vital” and “would be a big step forward… to gain clearer answers evaluated on biology rather than clinical assessments”.

Clinical Study

05 May 2023

·www.prnewswire.com

Nuclear Medicine Market worth $9.4 billion | MarketsandMarkets

CHICAGO, May 5, 2023 /PRNewswire/ -- The nuclear medicine industry is poised for significant growth in the near future, driven by the increasing incidence of cancer and chronic diseases that require advanced diagnostic and treatment options. Advancements in imaging technology, such as hybrid imaging and PET-CT scans, are also fueling demand for nuclear medicine. Additionally, there is a focus on developing radiopharmaceuticals and theragnostic that can target specific diseases and deliver treatments directly to affected areas. Despite potential challenges such as the high cost of equipment and the shortage of trained professionals, the outlook for the nuclear medicine industry is positive, and it is expected to continue to innovate and improve patient care in the coming years. Nuclear Medicine Market in terms of revenue was estimated to be worth $5.5 billion in 2023 and is poised to reach $9.4 billion by 2028, growing at a CAGR of 11.3% from 2023 to 2028 according to a new report by MarketsandMarkets™. The nuclear medicine market is mainly driven by factors such as rising incidence and prevalence of target disease and need for adoption of nuclear medicine for early diagnosis of diseases. However, hospital budget cuts and high equipment prices have made it difficult for a section of end users to opt for nuclear medicine are challenging the growth of this market. Download an Illustrative overview: Browse in-depth TOC on "Nuclear Medicine Market" 449 - Tables 39 - Figures 359 - Pages Nuclear Medicine Market Scope: The diagnostic nuclear medicine segment is expected to hold the largest market share during the forecast period. On the basis of type, the nuclear medicine market is segmented into diagnostic and therapeutic nuclear medicine. The diagnostic nuclear medicine segment is further categorized as SPECT and PET radiopharmaceuticals, while the therapeutic nuclear medicine segment is further divided into beta emitters, alpha emitters, and brachytherapy isotopes. The diagnostic nuclear medicine segment is expected to holds the largest share of the nuclear medicine market during forecast period. The rising prevalence of cancer and cardiovascular diseases, and advancements in radiotracers are some of the key factors driving the growth of this segment. The diagnostic procedure segment is projected to hold the largest market share during the forecast period. On the basis of procedural volume, the nuclear medicine market is segmented into diagnostic and therapeutic procedures. The diagnostic procedure segment is further categorized as SPECT and PET procedures. The diagnostic procedures accounted for the largest share, in the nuclear medicine market. The large share of this segment can be attributed to the diagnostic radioisotopes finding wider demand and use as compared to therapeutic radioisotopes. The diagnostic application segment is expected to account for the largest share of the nuclear medicine application market in 2022. On the basis of application, the nuclear medicine market is segmented into diagnostic and therapeutic applications. The diagnostic application segment is further categorized as SPECT and PET applications, while the therapeutic nuclear medicine segment is further divided into endocrine tumors, thyroid indications, bone metastasis, lymphoma, other therapeutic applications. The diagnostic application segment is expected to account for the largest share of the nuclear medicine market. The increasing demand for SPECT diagnosis owing to the rising demand for minimally invasive surgeries and targeted radiotherapy is the major factor driving the adoption of the diagnostic application using nuclear medicine. North America accounted for the largest share for players operating in the nuclear medicine market in 2022 On the basis of region, the nuclear medicine market is bifurcated into North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America holds the largest share of the nuclear medicine market in 2022. This can be attributed to the rising surge of geriatric population, growing requirement of nuclear medicine in the early diagnosis of diseases, technology advancement for radioisotope production, government funding, and key players in this region are also impelling the nuclear medicine market in the region. Inquiry Before Buying: Nuclear Medicine Market Dynamics: Drivers: Increasing incidence and prevalence of target conditions Development of alpha-radioimmunotherapy-based targeted cancer treatments Initiatives to reduce demand and supply gap of Mo-99 Restraints: Short half-life of radiopharmaceuticals Opportunities: Use of radiopharmaceuticals in neurological applications Growth opportunities in emerging economies Challenges: Hospital budget cuts and high equipment costs Key Market Players: The nuclear medicine market is highly consolidated. Some of the major players operating in this market include GE HealthCare (US), Cardinal Health (US), Curium (France),Bayer AG (Germany), Lantheus Holdings, Inc.(US), Bracco Imaging S.p.A. (Italy), PharmaLogic Holdings Corp. (US), Eczacibasi-Monrol Nuclear Products (Turkey), NTP Radioisotopes SOC Ltd (South Africa), Nordion Inc.(Canada), Advanced Accelerator Applications (France), NorthStar Medical Radioisotopes (US), Eckert & Ziegler (Germany), Isotope JSC (Russia), Siemens Healthineers (Germany), Jubilant DraxImage,Inc. (Canada). Get 10% Free Customization on this Report: Recent Developments: In January 2023, NorthStar Medical Radioisotopes (US) achieved a major milestone in advancing its new technology for non-uranium-based production of the critical medical radioisotope, molybdenum-99 (Mo-99). In November 2022, Curium (France) announced that the US Food and Drug Administration (FDA) approved DaTscan (Ioflupane I 123 Injection) to assist in evaluating adult patients with suspected Parkinsonian Syndromes. In October 2022, Blue Earth Diagnostics (UK) signed a data-sharing agreement with Siemens Healthineers (Germany) and the University Hospital of the Technical University of Munich (TUM) for 18F-rhPSMA-7.3, an investigational PET imaging agent, to support AI-based algorithms development. In January 2021, Advanced Accelerator Applications (France) signed a multi-year exclusive supply agreement for lutetium-177 with the University of Missouri Research Reactor (MURR). Through this agreement, MURR will supply AAA with GMP-quality lutetium-177 chloride, the precursor for developing Lutathera and other Lu-177-based therapeutics. Nuclear Medicine Market Advantages: Accurate diagnosis: nuclear medicine allows for highly accurate diagnosis of various diseases and conditions, including cancer, heart disease, and neurological disorders. This is because it enables imaging and functional assessment at a molecular level, providing more precise information about the disease. Personalized treatment: Radiopharmaceuticals used in nuclear medicine can be customized to target specific tissues or cells, enabling personalized treatment for patients. This approach can improve treatment outcomes and reduce side effects. Minimally invasive: nuclear medicine procedures are minimally invasive and require only small amounts of radioactive materials. This means that they are generally safer and less invasive than surgical procedures. Early detection: nuclear medicine can detect diseases and conditions at an early stage, before symptoms appear. This can lead to earlier treatment and better outcomes. Non-invasive: Nuclear medicine procedures are generally non-invasive, which means they do not require incisions or other invasive techniques. This can lead to faster recovery times and lower risk of complications. Nuclear Medicine Market - Report Highlights: The updated version of the report covers the historical market for the nuclear medicine market for the years 2021 and 2022, the estimated market for 2023, and the forecast for 2028, along with CAGR from 2023 to 2028. UPDATED MARKET OVERVIEW: The current edition of the report covers regulatory bodies, government agencies, and other organizations, industry trends, pricing analysis, key conferences & events, pipeline analysis, and key stakeholders & buying criteria in the market overview chapter. ADDITION OF END USER: The current edition of the report includes the end user chapter. UPDATED COMPETITIVE LANDSCAPE CHAPTER: The competitive landscape chapter has been updated with the company evaluation quadrant (DIVE Matrix), company evaluation quadrant for start-ups, footprint of nuclear medicine/radiopharmaceuticals market by type, and geographical assessment of the top market players. The competitive landscape also includes the updated strategies adopted by key players, a revenue share analysis of the top market players, as well as competitive situations and trends section. COMPANY PROFILES: Company profiles give a glimpse of the key players in the market with respect to business overviews, financials, product offerings, and recent developments. One additional company profile has been added (a total of 25 companies profiled). UPDATED FINANCIAL INFORMATION/PRODUCT PORTFOLIOS OF PLAYERS: The new edition of the report provides updated financial information in the context of the nuclear medicine market until 2022 for each listed company in a graphical representation in a single diagram (instead of multiple tables). This will easily help analyze the present status of profiled companies in terms of their financial strength, key revenue-generating country/region, business segment focus in terms of the highest revenue-generating segment, and investments in R&D activities. UPDATED MARKET DEVELOPMENTS OF PROFILED PLAYERS: Recent developments are important to understand the market trend and growth strategies adopted by players in the global nuclear medicine market space. The current edition of this report provides updated developments of profiled players from January 2019 to March 2023, indicating a continuation of the previous version. Partnerships, collaborations, agreements, product approval & enhancements, expansions, and acquisitions have been the principal growth strategies adopted by the market players in this period. ADDITION OF RECESSION IMPACT: The current edition of the report consists of the impact of the recession on the nuclear medicine/radiopharmaceuticals market. A section on the impact of the recession on all regional markets, such as North America, Asia Pacific, Europe, and Rest of the World have been included. Related Reports: Radiation Detection Monitoring Safety Market - Global Forecasts to 2027 Surgical Robots Market - Global Forecasts to 2027 Electroceuticals Market - Global Forecasts to 2026 Diagnostic Imaging Market - Global Forecasts to 2026 Nuclear Imaging Equipment Market - Global Forecasts to 2025 About MarketsandMarkets™: MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients. The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry. To find out more, visit ™.com or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Aashish Mehra MarketsandMarkets™ INC. 630 Dundee Road Suite 430 Northbrook, IL 60062 USA: +1-888-600-6441 Email: [email protected] Research Insight: Visit Our Website: Content Source: Logo: SOURCE MarketsandMarkets

100 Deals associated with Ioflupane-I-123

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KEGG	Wiki	ATC	Drug Bank
D10014	Ioflupane-I-123	V09AB03	DB08824

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lewy Body Disease	US	GE Healthcare, Inc.	01 Nov 2022
Diagnostic agents	JP	Nihon Medi-Physics Co., Ltd.	20 Sep 2013
Parkinsonian Disorders	EU	GE Healthcare B.V.	27 Jul 2000
Parkinsonian Disorders	IS	GE Healthcare B.V.	27 Jul 2000
Parkinsonian Disorders	LI	GE Healthcare B.V.	27 Jul 2000
Parkinsonian Disorders	NO	GE Healthcare B.V.	27 Jul 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	CN	GE Healthcare B.V.	28 Jun 2020
Alzheimer Disease	Phase 3	CN	GE Healthcare (Shanghai) Co. Ltd.	28 Jun 2020
Alzheimer Disease	Phase 3	CN	GE Healthcare Pvt Ltd.	28 Jun 2020
Essential Tremor	Phase 3	CN	GE Healthcare Holdings, Inc.	28 Jun 2020
Essential Tremor	Phase 3	CN	GE Healthcare (Shanghai) Co. Ltd.	28 Jun 2020
Essential Tremor	Phase 3	CN	GE Healthcare B.V.	28 Jun 2020
Essential Tremor	Phase 3	CN	GE Healthcare Pvt Ltd.	28 Jun 2020
Multiple System Atrophy	Phase 3	CN	GE Healthcare Holdings, Inc.	28 Jun 2020
Multiple System Atrophy	Phase 3	CN	GE Healthcare B.V.	28 Jun 2020
Multiple System Atrophy	Phase 3	CN	GE Healthcare (Shanghai) Co. Ltd.	28 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04193527 (CTgov)	Phase 3	Essential Tremor \| Parkinson Disease \| Multiple System Atrophy ... View more	172	DaTSCAN™ ioflupane (123I) (DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS))	otzmqsfsgt(fweyqnjlla) = spltbfoewg ghghbwwalp (aoyivbwycj, cthrypgbxw - atscuyitco) View more	-	16 Oct 2023
				DaTSCAN™ ioflupane (123I) (DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET))	ptlptpsfbc(rotfehkkwi) = pdyrwqupmf wbuxlzgomy (qhbjlrwxwe, lxsqthhdxd - bgmkhxfdmu) View more
NCT04564092 (CTgov)	Phase 1	Spherocytosis, Type 1	9	DaTSCAN™ Ioflupane (123I) Injection	einlfecjkr(fnokqybrnj) = bewzyzrfii pjzhheasjz (ejxxgvftvj, dknmroedjn - kxokzawzkc) View more	-	02 Aug 2023
AAN2022	Not Applicable	REM Sleep Behavior Disorder	34	123I-FP-CIT	rhxsibbyiu(kwntyhlwny) = kstqbbfmmy kvwsyfplvz (qkswclnegr ) View more	-	03 May 2022
				123I-FP-CIT	rhxsibbyiu(kwntyhlwny) = kgujagihag kvwsyfplvz (qkswclnegr ) View more
MDS2020	Not Applicable	123I-FP-CIT SPECT	20	123I-FP-CIT	uxdofoqpxd(cehgluqvqv) = lztfddqaph ocidjcpyhx (bknajdrmvk, 2.64)	-	12 Sep 2020
				123I-FP-CIT	uxdofoqpxd(cehgluqvqv) = yqmojeudph ocidjcpyhx (bknajdrmvk, 3.46)
MDS2020	Not Applicable	Parkinsonian Disorders \| Tremor \| Parkinson Disease	114	123I-ioflupane	vpsqeadhrf(lhukmehxfs) = begkxcfbve upoxlyyrll (ifznwasysb )	Positive	12 Sep 2020
				123I-ioflupane	vpsqeadhrf(lhukmehxfs) = xhlqanmdfs upoxlyyrll (ifznwasysb )
Parkinson’s Progression Markers Initiative (PPMI) (MDS2019)	Not Applicable	Parkinson Disease [123I]-Ioflupane-SPECT	389	[123I]FP-CIT	bzvccrlmsj(eirypufiao): HR = 1.823 (95% CI, 1.176 - 2.827), P-Value = 0.007	-	22 Sep 2019
				[123I]FP-CIT
NCT03185182 (CTgov)	Phase 2	Renal Cell Carcinoma	5	Ioflupane I123	ycewmschys(zjkvkfubog) = nkpnqxsogm majfqebqws (qozmaaxsci, jocfcagisl - tjchlcpmjt) View more	-	21 Jun 2019
MDS2018	Not Applicable	REM Sleep Behavior Disorder \| Parkinson Disease	212	123I-FP-CIT	dcjpwgupkb(kcnusvmrrq) = pwzujxuzmn ywlvmjjcix (yqlxltvcxs ) View more	-	05 Oct 2018
Newcastle LewyPro study (AAIC2017)	Not Applicable	Lewy Body Disease	75	FP-CIT (Probable MNCD-LB)	kvkirxickl(kyubcqglbm) = wiqqtqdaqf hkhzutuicq (zuiltggjkq ) View more	-	01 Jul 2017
				FP-CIT (Possible MNCD-LB)	kvkirxickl(kyubcqglbm) = rucgjdsesh hkhzutuicq (zuiltggjkq ) View more
MDS2017	Not Applicable	Parkinson Disease DAT SPECT \| Specific Binding Ratio (SBR)	49	123I-FP-CIT	tlqqudohnr(jqliugvgxj) = hjlraoguie btimhyzjjj (suvzexyvwe, ±2.7)	Positive	04 Jun 2017

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Core Patent

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis