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Last update 15 Jul 2026
Ioflupane-I-123
Last update 15 Jul 2026
Overview
Basic Info
Drug Type Small molecule drug, Diagnostic radiopharmaceuticals |
Synonyms 123I-Ioflupane, DATrace-123, Iodine ioflupane (123I) + [17] |
Target |
Action modulators, enhancers |
Mechanism DAT modulators(Dopamine transporter modulators), SPECT(Single-photon emission-computed tomography enhancers) |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (27 Jul 2000), |
Regulation- |
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Structure/Sequence
Molecular FormulaC18H23FINO2 |
InChIKeyHXWLAJVUJSVENX-HFIFKADTSA-N |
CAS Registry155798-07-5 |
Related
22
Clinical Trials associated with Ioflupane-I-123NCT06828705
Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride (CZT) Camera (VERITON-CT)
Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).
Start Date30 Jul 2025 |
Sponsor / Collaborator- |
NCT04564092
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 |
NCT04193527
A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls
This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease [PD] [SDD], multiple system atrophy [MSA] [SDD] or or progressive supranuclear palsy [PSP] [SDD]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.
Start Date28 Jun 2020 |
Sponsor / Collaborator |
100 Clinical Results associated with Ioflupane-I-123
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100 Translational Medicine associated with Ioflupane-I-123
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100 Patents (Medical) associated with Ioflupane-I-123
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361
Literatures (Medical) associated with Ioflupane-I-12301 May 2026·Clinical Case Reports
Geriatric Depression Mimicking Parkinson's Disease: A Case of Levodopa‐Responsive Pseudoparkinsonism With a 3‐Year Follow‐Up
Article
Author: Toda, Masashi ; Nabeshima, Yoshihiro ; Imaizumi, Kenshiro ; Nakamura, Yohei ; Watanabe, Tetsuya ; Goto, Junichi ; Yamashiro, Sachi ; Oyamada, Suzuha ; Hirazumi, Koki ; Isoda, Kazuya
ABSTRACT:
Geriatric depression often presents with psychomotor retardation. Severe psychomotor retardation may manifest as pseudoparkinsonism, which mimics Parkinson's disease (PD) and is often difficult to treat with standard antidepressant therapy. We report a case of a woman in her 60s with recurrent major depression with melancholic features who remained symptomatic despite several months of vortioxetine augmented with aripiprazole. She developed overt parkinsonism, including asymmetric rest tremor, rigidity, bradykinesia, and postural instability, requiring wheelchair assistance (Hoehn and Yahr stage 5). A diagnostic trial of levodopa produced marked improvement in both motor and depressive symptoms, leading to a presumptive diagnosis of comorbid PD. However, a subsequent dopamine transporter scan (DaTscan) showed normal striatal uptake, which argued against neurodegeneration. The final diagnosis was considered most consistent with geriatric depression with pseudoparkinsonism. During the 3 years of follow‐up, her depressive symptoms showed a clear temporal association with levodopa: symptoms worsened after discontinuation and remitted after reintroduction. This case highlights that pseudoparkinsonism in geriatric depression can closely mimic PD and that DaTscan may help exclude neurodegenerative parkinsonism. These findings also suggest that levodopa may be considered in selected cases of difficult‐to‐treat geriatric depression with pseudoparkinsonism.
30 Apr 2026·Brain Sciences
Combined Striatal Dopaminergic and Cardiac Sympathetic Imaging in Parkinson's Disease.
Review
Author: Vandenberghe, Wim ; Delva, Aline ; Vanderlinden, Greet ; Versweyveld, Louis ; Van Laere, Koen
Background/Objectives: Imaging of both cardiac sympathetic denervation and nigrostriatal dopaminergic degeneration can support the diagnosis of Parkinson's disease (PD). However, their temporal relationship and combined diagnostic value remain unclear. This review addresses (1) whether nigrostriatal degeneration and cardiac sympathetic denervation are correlated in PD and (2) the comparative and combined diagnostic accuracy of striatal dopaminergic and cardiac sympathetic imaging in PD. Methods: We searched PubMed (October 2025) for studies assessing both a striatal dopaminergic and a cardiac sympathetic imaging biomarker in the same PD cohort, supplemented by citation chaining. Diagnostic accuracy studies were evaluated using QUADAS-2. Results: Nineteen studies met the inclusion criteria. Ten studies examined within-subject associations; six reported significant correlations ranging from weak to strong (ρ ~0.2-0.8). Two studies observed a significant correlation for the akinetic-rigid subtype but not for the tremor-dominant subtype of PD. Ten studies compared diagnostic accuracies, five of which used pre-defined thresholds and consistently found higher sensitivity for [123I]FP-CIT SPECT (78-100%) compared to [123I]MIBG scintigraphy (65-82%), but higher specificity for [123I]MIBG (range 75-100%) than for [123I]FP-CIT (range 11-73%). Adding [123I]MIBG scintigraphy to [123I]FP-CIT SPECT generally increased specificity but had inconsistent effects on overall accuracy. QUADAS-2 revealed substantial risks of patient selection bias, data-driven thresholds, and limited blinding. Conclusions: Reported correlations between nigrostriatal dopaminergic degeneration and cardiac sympathetic denervation in PD are inconsistent, likely reflecting both methodological heterogeneity and real variation between phenotypes. There may be a stronger correlation in the akinetic-rigid phenotype. Dopaminergic imaging is more sensitive in early PD, while cardiac sympathetic imaging is more specific for differentiating PD from atypical Parkinsonian syndromes. However, study designs greatly restrict the generalizability of reported diagnostic accuracies.
01 Apr 2026·NUKLEARMEDIZIN-NUCLEAR MEDICINE
Difficult-to-interpret dopamine transporter SPECT with [123I]ioflupane in the diagnosis of parkinsonism
Article
Author: Jedid, Loren ; Apostolova, Ivayla Ilieva ; Braren, Rickmer ; Klutmann, Susanne ; Buchert, Ralph ; Buddenkotte, Thomas ; Meyer, Philipp T
Abstract:
To estimate (i) the rate of difficult-to-interpret cases in dopamine transporter (DAT)-SPECT with [123I]ioflupane and (ii) the diagnostic accuracy of binary visual categorization in difficult-to-interpret DAT-SPECT.The study included 178 control subjects (49% females, 63.7±11.7y) and 178 sex- and age-matched patients with pre-screening clinical diagnosis of Parkinson’s disease (PD) from the Parkinson’s Progression Markers Initiative (PPMI). SPECT images reconstructed by the PPMI and a local method were visually interpreted twice by 2 independent readers with respect to Parkinson-like reduction of the striatal signal using the following 6-score: –3 = clearly reduced, –2 = probably reduced, –1 = more likely reduced than normal, 1 = more likely normal than reduced, 2 = probably normal, 3 = clearly normal. Cases with 6-score of –1 or 1 were considered “difficult-to-interpret”, all other cases were considered “conclusive”. To assess diagnostic accuracy relative to the clinical group label (control, PD), the 6-score was binarized using 0 as cutoff.The proportion of difficult-to-interpret cases ranged between 3.4% (95%-CI 1.5–5.2%) and 7.6% (4.8–10.3%) across readers and reconstruction methods. The proportion of cases misclassified by the binarized score ranged between 17.4% (1.9–32.9%) and 50.0% (25.5–74.5%) among the difficult-to-interpret cases, and between 5.1% (2.7–7.4%) and 6.4% (3.8–9.0%) among the conclusive cases.(i) the proportion of difficult-to-interpret cases in DAT-SPECT for the diagnosis of parkinsonism is not larger than 10%, (ii) the diagnostic accuracy of binary decisions is severely reduced in these cases. We therefore recommend reporting difficult-to-interpret cases as “inconclusive”, unless in special situations.
12
News (Medical) associated with Ioflupane-I-12301 Jun 2026
Nuclear medicine is reaching an inflection point as advances in imaging, theranostics and radiopharmaceuticals help accelerate clinical adoption
At #SNMMI26, GE HealthCare is showcasing solutions designed to expand access, streamline workflows and support precision care across care pathways
CHICAGO--(BUSINESS WIRE)--As theranostics adoption acceleratesi and radiopharmaceutical demand grows,ii healthcare systems are under increasing pressure to scale nuclear medicine operations while improving diagnostic confidence and workflow efficiency. At the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, GE HealthCare showcases its latest technologies and AI-enabled workflows to help support precision care across care pathways.
“This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD.
Nuclear medicine is undergoing rapid expansion as healthcare systems increase adoption of theranostics, broaden radiopharmaceutical access and invest in precision diagnostics and targeted therapies. This momentum is also evident in global nuclear medicine market projections, which anticipate growth from approximately $7.8 billion in 2024 to more than $30.7 billion by 2034.iii
“Nuclear medicine is moving from early innovation to large-scale clinical implementation,” shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography (MICT), GE HealthCare. “Healthcare systems need technologies and workflows that help expand access, improve efficiency and support more confident clinical decision-making as theranostics adoption and precision care evolve.”
Turning convergence into clinical reality
Growing demand for precision diagnostics and targeted therapies is helping accelerate the evolution of nuclear medicine. Advances in radiopharmaceuticals and imaging technologies help clinicians diagnose disease, improve treatment planning and expand access to personalized care. As adoption increases, healthcare systems are also facing new operational challenges – including how to scale infrastructure, streamline workflows and expand patient access beyond traditional hospital settings.iv
Rising prevalence of chronic diseases is further driving demand for timely and advanced diagnoses and targeted treatment approaches. Fortunately, new care delivery models are already taking shape across care pathways. These models are increasingly enabled by advances in radiopharmaceuticals that expand access to PET imaging and support more scalable, routine clinical use across care settings.
Early examples of this shift are emerging to reach patients beyond traditional hospital environments:
Cardiology : GE HealthCare’s Flyrcado™ (flurpiridaz F 18 injection) is helping expand access to PET myocardial perfusion imaging (MPI) through a ready-to-use, unit-dose model designed for routine clinical workflows. The company is also collaborating with channel partners to accelerate the adoption of cardiac PET MPI in community settings while mobile imaging models are extending access beyond traditional hospital environments, bringing precision PET imaging to sites that may not otherwise have access.
Neurology : As demand for Alzheimer’s diagnostics grows, v GE HealthCare offers Vizamyl™ (flutemetamol F 18 injection) and quantitative tools such as MIMneuro™ to support more consistent amyloid PET interpretation and clinical decision-making. These technologies can help providers integrate amyloid imaging more efficiently into routine neurological care pathways.
Oncology : Theranostics adoption is also accelerating, i causing healthcare systems to seek more standardized approaches to imaging, treatment planning and response assessment. GE HealthCare’s StarGuide SPECT/CT, Intelligent Radiation Therapy (iRT) and MIM portfolio are designed with these needs in mind – helping simplify whole-body tumor burden assessment, streamline workflows and support more consistent treatment planning across care settings. These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time.
These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time.
“This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD, FACNM, FACR, FSNMMI, Chief Medical Officer at United Theranostics and System Chief of Nuclear Medicine at the Mount Sinai Health System in New York. “Technologies that combine advanced imaging, quantitative analysis and innovative radiopharmaceuticals are helping clinicians make more informed decisions earlier in the care pathway – ultimately improving how we diagnose, treat and monitor patients.”
GE HealthCare’s nuclear medicine portfolio spans imaging systems, AI-enabled software and pharmaceutical diagnostics designed to help clinicians support the full patient journey — from detection and diagnosis through therapy planning and monitoring.
Translating rapid innovation into real-world clinical impact
At SNMMI 2026, GE HealthCare is highlighting key technologies and software designed to help healthcare systems scale precision imaging, theranostics and quantitative analysis across clinical and research settings:
Advanced imaging technologies –
MIM KineticID ™: vi Advanced 510(k)-pending software designed for dynamic PET imaging and kinetic modeling, enabling quantitative, time-based analysis of radiotracer behavior to support more informed clinical and research decisions.
MIM LesionID™ Pro : Recently 510(k) cleared by the U.S. FDA , this AI-powered software automates whole-body tumor burden analysis, reducing the need for manual lesion segmentation, physiologic uptake removal, or multi-image registration while enabling fast access to quantitative insights.
Omni Legend : GE HealthCare’s fastest-selling PET/CT platform, now with more than 500 installations worldwide. vii Its high-sensitivity design supports faster scans, viii improved image quality and enhanced lesion detectability. ix Omni Legend also includes Precision DL deep learning image processing.
StarGuide : A digital SPECT/CT platform featuring 12 CZT detectors and optimized for certain theranostic procedures, enabling high-quality 3D imaging, short scan times and quantitation.
MINItrace Magni : x A compact cyclotron solution designed to simplify onsite production of PET tracers and radiometals, including Gallium-68, helping expand radiopharmaceutical access and support more localized production and personalized care delivery.
Radiopharmaceuticals and imaging agents –
Flyrcado : A PET imaging agent that helps doctors evaluate myocardial ischemia and infarction in people with known or suspected coronary artery disease, including during exercise stress tests.
DaTscan ™ (ioflupane I‑123 injection): A proven neurological diagnostic radiopharmaceutical – celebrating 25 years in the global market – to visualize striatal dopamine transporters assisting in the evaluation of patients with suspected Parkinsonian syndromes (PSs) and suspected dementia with Lewy bodies (DLB).
Cerianna ™ (fluoroestradiol F 18 injection): A PET radiopharmaceutical used to detect estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Vizamyl : A PET imaging agent used to estimate amyloid beta neuritic plaque density in adults with cognitive impairment to support evaluation of Alzheimer’s disease and other causes of cognitive decline, and to help inform selection of patients for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.
Together, these imaging technologies and agents are designed to support more scalable, data-driven and personalized nuclear medicine workflows across care pathways.
Preparing the ecosystem for the next decade of growth
As nuclear medicine adoption continues to grow, healthcare systems are increasingly focused on the operational requirements needed to support broader clinical use – including infrastructure, workflow standardization, radiopharmaceutical access and scalable decision support. xi
Quantification and advanced imaging analytics are expected to play an increasingly important role in this evolution, particularly in neurodegenerative disease and theranostics, where more standardized interpretation and longitudinal assessment may help advance consistency across sites and clinicians.
One way GE HealthCare is aiming to advance this evolution is through Adaptive Theranostics – a model that combines molecular imaging, quantitative analytics and connected clinical workflows to help clinicians personalize radioligand therapy decisions across treatment cycles. By supporting more consistent quantification, longitudinal assessment and multidisciplinary collaboration, Adaptive Theranostics is designed to help healthcare systems scale precision care as theranostics adoption grows.
“As molecular imaging continues to scale, success will depend on more than individual products – it requires building the ecosystem around them,” says Eric Ruedinger, Vice President and General Manager, Pharmaceutical Diagnostics (PDx), USCAN, GE HealthCare. “We’re focused on enabling that ecosystem end-to-end – from tracer development and manufacturing to expanding access, integrating workflows and advancing the tools that support confident, consistent decision-making – so precision care can move from promise to sustained, everyday practice.”
SNMMI 2026 represents a pivotal moment for the field – where decades of innovation are converging with new care models and expanding access to redefine how nuclear medicine is delivered.
As these capabilities continue to scale, nuclear medicine is increasingly positioned as a cornerstone of precision medicine – enabling clinicians to visualize the biology of disease, tailor therapies to individual patients and monitor treatment response.
To learn more about GE HealthCare’s full suite of nuclear medicine solutions, please visit gehealthcare.com.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Advanced Imaging Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2026 Fortune World’s Most Admired Companies™.
Follow us on LinkedIn, Facebook, Instagram, or visit our website for our latest news and perspectives.
Important Safety Information
Cerianna™ (fluoroestradiol F 18 injection)
Indication and Usage:
Cerianna is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Limitations of Use:
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. Cerianna is not useful for imaging other receptors such as HER2 or progesterone receptor (PR).
Contraindications:
None.
Adverse Reactions:
In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, please visit:
https://www.gehealthcare.com/-/jssmedia/GEHC/US/Files/Products/Nuclear-Imaging-Agents/Cerianna/cerianna-pi
DaTscan™ (ioflupane I‑123 injection)
Indication and Usage:
DaTscan 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).
Contraindications:
Known hypersensitivity to ioflupane I‑123 or its components.
Adverse Reactions:
In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness were reported at a rate of 1% or less. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information.
Flyrcado™ (flurpiridaz F 18 injection)
Indication and Usage:
Flyrcado is a radioactive diagnostic drug indicated for PET myocardial perfusion imaging (MPI) under rest or stress in adult patients with known or suspected coronary artery disease (CAD) to evaluate myocardial ischemia and infarction. [accessdata.fda.gov]
Contraindications:
None.
Adverse Reactions:
The most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, click here. For important safety information, please click here.
Vizamyl™ (flutemetamol F 18 injection)
Indication and Usage:
VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline; and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products
Contraindications:
Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80.
Adverse Reactions:
The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%). Post marketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, please visit:
https://www.gehealthcare.com/content/dam/gehc/global/products/molecular-imaging-agents/vizamyl/documents/er-clinical-product-pi-en.pdf
May 2026 JB14025US
i Ezhilarasan, E., Sabarees, G. & Premkumar, P.P. Radioligand theranostics in oncology: emerging trends in target design and radiochemical innovation. J Radioanal Nucl Chem (2026). https://link.springer.com/article/10.1007/s10967-026-10891-3.
ii Research and Markets. Radiopharmaceuticals Market Report 2026. Dublin: Research and Markets, 2026. https://www.researchandmarkets.com/reports/5939063/radiopharmaceuticals-market-report.
iii Global Market Insights. U.S. Nuclear Medicine Market Size & Share, 2025–2034. Published October 2025. Accessed May 4, 2026. https://www.gminsights.com/industry-analysis/us-nuclear-medicine-market.
iv Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com
v Grand View Research. U.S. Alzheimer’s Disease Diagnostics Market Report, 2030. San Francisco: Grand View Research, 2025. https://www.grandviewresearch.com/industry-analysis/us-alzheimers-disease-diagnostics-market-report.
vi MIM KineticID is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.
vii GE HealthCare data on file.
viii Up to 53% reduction of PET scan time on Omni Legend 32 cm compared to Discovery MI 25 cm, as demonstrated in phantom testing.
ix Omni Legend 32 cm increases small lesion detectability 16% on average and up to 20%, as compared to Discovery MI 25 cm with matched scan time/injected dose, as demonstrated in phantom testing using a model observer with 4 mm lesions; average of different reconstruction methods.
x MINItrace Magni is technology in development. Not CE marked.
xi Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com
23 Mar 2026
Oryon Cell Therapies\' lead program is in an ongoing phase 1b/2a trial in which participants received a unilateral neuronal implant to improve the dopamine system in patients with Parkinson\'s disease.\n When Ron Cohen, M.D., CEO of Oryon Cell Therapies, recently dug into the company’s Parkinson’s disease data, he told Fierce Biotech it “sang” to him. The former internist-turned-biotech CEO knew a thing or two about Parkinson’s—an area Oryon is targeting with an autologous neuron replacement therapy designed to restore dopaminergic function.Cohen founded Acorda Therapeutics more than three decades ago. As CEO, he led the development of Inbrija, an approved inhaled treatment for Parkinson’s patients whose other medications wear off prematurely. After selling the company\'s commercial drugs to Merz, he jumped at the opportunity to once again lead a Parkinson’s-focused venture—particularly as the son of a neurologist.Oryon is emerging from stealth with a $21 million tranche of series A round, bringing its total funding—including grants—to $42 million. The funding was a key factor in Cohen’s decision to join as CEO. Investors include Neuro.VC, Byers Capital and others.Cohen said he was particularly impressed by the company’s data. Its lead program is in an ongoing phase 1b/2a trial in which participants received a unilateral neuronal implant. According to Cohen, the therapy has shown improvements in motor function, along with neuroimaging evidence suggesting restoration of dopaminergic signaling in the transplanted brain region.Oryon is far from the only company pursuing stem cell therapies for Parkinson’s by targeting dopamine production. Aspen Neuroscience recently announced plans for a phase 3 trial after reporting one-year data showing improved symptoms across all patients in its phase 1/2a study. Hope Biosciences has also linked its stem cell candidate to improved motor function in a phase 2 trial, while Bayer has moved into late-stage testing with a therapy aimed at reducing Parkinson’s-related involuntary movements. Oryon’s approach, however, is differentiated and includes a built-in control. Cohen explained that most therapies rely on neuronal progenitor cells, which are implanted into the brain, where they multiply and eventually become A9 neurons—the primary dopamine-producing cells that degenerate in patients with Parkinson’s and drive the condition’s motor symptoms.By contrast, Oryon implants fully developed A9 neurons from the outset, aiming to restore dopamine production more directly. Another key distinction is its unilateral approach: The company treats only one side of the brain, whereas most competing programs use bilateral treatment.Cohen noted that this strategy allows comparisons not only with bilateral programs but also within the same patient—against the untreated side of the brain. The company has measured increasing signals of dopamine synaptic activity on the implanted side compared to the untreated half of the brain, and says the treatment corresponds with the functional improvements in patients.Using a DaTscan, which evaluates the brain’s dopamine system, Oryon measures dopamine restoration on the treated side while tracking motor recovery. This creates something close to a built-in control arm, as outcomes can be compared to the untreated hemisphere.Because Parkinson’s and other neurological diseases are particularly susceptible to placebo effects, Cohen said the imaging data are critical for assessing true efficacy. The company presented interim trial data at the AD/PD 2026 International Conference on Alzheimer’s and Parkinson’s Diseases on March 21. Cohen said the results show unilateral treatment comparing favorably with bilateral approaches, and he expects the next phase of the trial to incorporate bilateral treatment.“One of the big questions we now have to answer is whether we’ll see meaningfully improved results over what we observed with unilateral implants,” Cohen said. “If we do, that’s very meaningful and exciting.”The strong placebo effect in Parkinson’s also raises the question of whether future trials should include sham surgeries. But that’s a complicated proposition considering the treatment procedure involves drilling a small hole in the skull and transplanting A9 neurons via a cannula. The absence of a sham control was a central issue when the FDA rejected uniQure’s data package for a closely watched gene therapy for Huntington’s disease.“If you don’t do a sham, you’re shortchanging everyone in the process,” Cohen said. “You have to be ethical—and if patients are in the placebo group and the trial succeeds, they should be eligible to receive the actual therapy.”Cohen recalled the first time, as a medical student, he walked into a hospital room and a patient addressed him as “doctor”—a moment that underscored the privilege of helping others. That sense of purpose, he said, is magnified in drug development, where the impact can reach tens of thousands of patients.“When patients come up and tell us what our treatment has meant to their lives—that’s why I couldn’t stay away.”
Phase 2Phase 3Cell Therapy
30 Sep 2025
Acetaminophen-containing products
Anaphylactic reaction
FDA is evaluating the need for regulatory action.
Aptryxol (desvenlafaxine)
DaTscan (ioflupane I 123 injection)
Desvenlafaxine extended-release tablets
Effexor XR (venlafaxine extended-release) capsules
Pristiq (desvenlafaxine) extended-release tablets
Venlafaxine (venlafaxine hydrochloride) extended-release tablets
False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine
FDA is evaluating the need for regulatory action.
Barium sulfate-containing products
Entero Vu 24% (barium sulfate) oral suspension
E-Z-Disk (barium sulfate) tablets
Liquid E-Z-Paque (barium sulfate) oral suspension
Readi-Cat 2 (barium sulfate) oral suspension
Readi-Cat 2 Smoothie (barium sulfate) oral suspension
Taglitol V (barium sulfate) oral suspension
Varibar Honey (barium sulfate) oral suspension
Varibar Nectar (barium sulfate) oral suspension
Varibar Pudding (barium sulfate) oral paste
Varibar Thin Honey (barium sulfate) oral suspension
Varibar Thin Liquid (barium sulfate) oral suspension
Anaphylactic reaction
FDA is evaluating the need for regulatory action.
Blincyto (blinatumomab) for injection
Columvi (glofitamab-gxbm) injection
Elrexfio (elranatamab-bcmm) injection
Epkinly (epcoritamab-bysp) injection
Imdelltra (tarlatamab-dlle) for injection
Kimmtrak (tebentafusp-tebn) injection
Lunsumio (mosunetuzumab-axgb) injection
Talvey (talquetamab-tgvs) injection
Tecvayli (teclistamab-cqyv) injection
Progressive multifocal leukoencephalopathy
FDA is evaluating the need for regulatory action.
BRAF kinase inhibitors
Braftovi (encorafenib) capsules
Ojemda (tovorafenib) for oral suspension; tablets
Tafinlar (dabrafenib) capsules; tablets
Zelboraf (vemurafenib) tablets
Gingival hypertrophy
FDA is evaluating the need for regulatory action.
Briumvi (ublituximab-xiiy) injection
Kesimpta (ofatumumab) injection
Acute hepatic failure
The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury.
Example:
Briumvi labeling
Briumvi (ublituximab-xiiy) injection
Kesimpta (ofatumumab) injection
Ocrevus (ocrelizumab) injection
Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection
Central nervous system infection
FDA is evaluating the need for regulatory action.
Crexont (carbidopa and levodopa) extended-release capsules
Dhivy (carbidopa and levodopa) tablets
Duopa (carbidopa and levodopa) enteral suspension
Rytary (carbidopa and levodopa) extended-release capsules
Sinemet (carbidopa and levodopa) tablets
Sinemet CR (carbidopa and levodopa) sustained-release tablets
Stalevo (carbidopa, levodopa and entacapone) tablets
Vyalev (foscarbidopa and foslevodopa) injection
Seizure
FDA is evaluating the need for regulatory action.
Crysvita (burosumab-twza) injection
Hypercalcemia
The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia.
Crysvita labeling
Dexmedetomidine-containing products
Dexmedetomidine injection
Precedex (dexmedetomidine hydrochloride) injection
Igalmi (dexmedetomidine) sublingual film
Diabetes insipidus
FDA is evaluating the need for regulatory action.
Dupixent (dupilumab) injection
Ocular infections, irritations, and inflammation
FDA is evaluating the need for regulatory action.
Eprontia (topiramate) oral solution
Qudexy XR (topiramate) extended-release capsules
Qsymia (phentermine and topiramate) extended-release capsules
Topamax (topiramate) tablets
Topamax Sprinkle (topiramate) capsules
Trokendi XR (topiramate) extended-release capsules
Hypersensitivity
FDA is evaluating the need for regulatory action.
Gavreto (pralsetinib) capsules
Chylothorax
FDA is evaluating the need for regulatory action.
Glucagon-like peptide-1 (GLP-1) receptor agonists
Adlyxin (lixisenatide) injection
Bydureon (exenatide) for extended-release injectable suspension
Bydureon BCise (exenatide extended-release) injectable suspension
Byetta (exenatide) injection
Mounjaro (tirzepatide) injection
Ozempic (semaglutide) injection
Rybelsus (semaglutide) tablets
Saxenda (liraglutide) injection
Soliqua 100/33 (insulin glargine and lixisenatide) injection
Trulicity (dulaglutide) injection
Victoza (liraglutide) injection
Wegovy (semaglutide) injection
Xultophy 100/3.6 (insulin degludec and liraglutide) injection
Zepbound (tirzepatide) injection
Intestinal obstruction and fecal impaction
FDA is evaluating the need for regulatory action.
Imbruvica (ibrutinib) capsules; tablets; oral suspension
Nail and nail bed conditions (excluding infections and infestations)
FDA is evaluating the need for regulatory action.
MEK inhibitors
Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets)
Cotellic (cobimetinib) tablets
Mekinist (trametinib) tablets; oral solution
Mektovi (binimetinib) tablets
Koselugo (selumetinib) capsules
Gingival hypertrophy
FDA is evaluating the need for regulatory action.
Neffy (epinephrine nasal spray)
Product storage error
FDA is evaluating the need for regulatory action.
Nurtec ODT (rimegepant) orally disintegrating tablets
Zavzpret (zavegepant) nasal spray
Anaphylactic reaction
The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis.
Example:
Nurtec ODT labeling
Rozlytrek (entrectinib) capsules; oral pellets
Brugada syndrome
FDA is evaluating the need for regulatory action.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
Fournier's gangrene
FDA is evaluating the need for regulatory action.
Teriparatide injection (a particular generic product)
Device malfunction
FDA is evaluating the need for regulatory action.
Vizamyl (flutemetamol F18 injection)
Anaphylactic reaction
The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions.
Vizamyl labeling
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Drug ApprovalBiosimilar
100 Deals associated with Ioflupane-I-123
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10014 | Ioflupane-I-123 |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Lewy Body Disease | United States | 01 Nov 2022 | |
| Diagnostic agents | Japan | 20 Sep 2013 | |
| Essential Tremor | South Korea | 15 Apr 2011 | |
| Parkinson Disease | South Korea | 15 Apr 2011 | |
| Parkinsonian Disorders | European Union | 27 Jul 2000 | |
| Parkinsonian Disorders | Iceland | 27 Jul 2000 | |
| Parkinsonian Disorders | Liechtenstein | 27 Jul 2000 | |
| Parkinsonian Disorders | Norway | 27 Jul 2000 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Dementia due to Parkinson's disease | Phase 3 | China | 28 Jun 2020 | |
| Dementia due to Parkinson's disease | Phase 3 | China | 28 Jun 2020 | |
| Dementia due to Parkinson's disease | Phase 3 | China | 28 Jun 2020 | |
| Multiple System Atrophy | Phase 3 | China | 28 Jun 2020 | |
| Multiple System Atrophy | Phase 3 | China | 28 Jun 2020 | |
| Multiple System Atrophy | Phase 3 | China | 28 Jun 2020 | |
| Multiple System Atrophy | Phase 3 | China | 28 Jun 2020 | |
| Primary Parkinson's disease | Phase 3 | China | 28 Jun 2020 | |
| Primary Parkinson's disease | Phase 3 | China | 28 Jun 2020 | |
| Primary Parkinson's disease | Phase 3 | China | 28 Jun 2020 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | 172 | (DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)) | ivnaayiwcv = laekxkgfly dkbzbmlmkw (zlufulkuvi, ixquzjindi - zjdnyzvlax) View more | - | 16 Oct 2023 | ||
(DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)) | ocenqcuelb = vwhhpipijj eatqcqgouf (mqwoaifacp, rxganvpasq - lyveurpunv) View more | ||||||
Phase 1 | - | 9 | myfkloouqt = tizciwukgy dyglateckp (wwemeusigk, keetkpenvs - ydipgtnwmr) View more | - | 02 Aug 2023 | ||
Not Applicable | 34 | qnduuotytg(cumseeujzz) = pqpwyhqiyi yvbvdxgdft (bhmxueqfak ) View more | - | 03 May 2022 | |||
qnduuotytg(cumseeujzz) = gfoplmbdyu yvbvdxgdft (bhmxueqfak ) View more | |||||||
Phase 2 | Parkinson Disease [123I]FP-CIT SPECT | 390 | (PD patients with gait impairment) | nwrueuzgod(erjsfigipm) = kgjgsvxxww mwpnhyubfm (dubpddjalv ) | Positive | 27 Jun 2019 | |
Phase 2 | Parkinson Disease [123I]FP-CIT SPECT | MDS-UPDRS | 389 | (PD patients with drooling) | nojjprucnq(jpojlbnoty): HR = 1.823 (95% CI, 1.176 - 2.827), P-Value = 0.007 | Positive | 27 Jun 2019 | |
(PD patients without drooling) | |||||||
Phase 2 | Parkinson Disease dopamine transporter (DAT) | 167 | 123-I Ioflupane SPECT | vptbcvtmht(xcwjvztsvo) = sqohhyamoj khopjysfod (igkiaoxsum ) | Positive | 06 Apr 2015 | |
Phase 2 | Parkinson Disease dopamine transporter SPECT imaging | 298 | 123-I Ioflupane SPECT | vntpjflrlq(byvdlcnmnk) = qqtujgvcty xoduxsrmfl (gzxjelrmmx, 15.6%) | Positive | 05 Nov 2014 | |
(PD subjects with 3 SPECT scans) | vntpjflrlq(byvdlcnmnk) = bbbzuikdkb xoduxsrmfl (gzxjelrmmx, 15.6%) | ||||||
Not Applicable | Lewy Body Disease 123I-FP-CIT SPECT | 325 | fpdlgffntx(wlzjqhtubi) = uqixvsjvdt xomszjhqjv (uuijmxvsrl ) View more | Positive | 01 Jul 2008 |
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