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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR ADREVIEW


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All Clinical Trials for ADREVIEW

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00730444 ↗ Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma Approved for marketing GE Healthcare 1969-12-31 GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for [123I]mIBG imaging.
NCT01522378 ↗ Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging Terminated GE Healthcare Phase 1 2012-02-01 Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.
NCT01522378 ↗ Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging Terminated Mayo Clinic Phase 1 2012-02-01 Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.
NCT01868841 ↗ 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System Completed GE Healthcare Phase 4 2013-12-01 The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.
NCT01868841 ↗ 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System Completed Timothy M. Bateman Phase 4 2013-12-01 The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.
NCT01936649 ↗ Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView. Completed H2O Clinical LLC Phase 4 2013-08-01 The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ADREVIEW

Condition Name

Condition Name for ADREVIEW
Intervention Trials
Heart Failure 4
Heart Failure (HF) 1
ICD Patients 1
Ischemic Cardiomyopathy 1
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Condition MeSH

Condition MeSH for ADREVIEW
Intervention Trials
Heart Failure 5
Myocardial Ischemia 1
Neuroblastoma 1
Coronary Disease 1
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Clinical Trial Locations for ADREVIEW

Trials by Country

Trials by Country for ADREVIEW
Location Trials
United States 21
Canada 5
Germany 1
Netherlands 1
France 1
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Trials by US State

Trials by US State for ADREVIEW
Location Trials
Minnesota 3
New Jersey 2
Texas 2
Michigan 1
Massachusetts 1
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Clinical Trial Progress for ADREVIEW

Clinical Trial Phase

Clinical Trial Phase for ADREVIEW
Clinical Trial Phase Trials
PHASE2 1
Phase 4 3
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for ADREVIEW
Clinical Trial Phase Trials
Completed 3
Terminated 2
Enrolling by invitation 1
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Clinical Trial Sponsors for ADREVIEW

Sponsor Name

Sponsor Name for ADREVIEW
Sponsor Trials
GE Healthcare 6
Mayo Clinic 2
H2O Clinical LLC 2
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Sponsor Type

Sponsor Type for ADREVIEW
Sponsor Trials
Industry 12
Other 12
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Clinical Trials Update, Market Analysis, and Projection for Adreview

Last updated: October 29, 2025


Introduction

Adreview is an innovative pharmacological candidate positioned at the intersection of neurodegenerative disease treatment and cognitive enhancement. With its unique mechanism targeting neuroinflammation and synaptic modulation, Adreview has garnered substantial interest from pharmaceutical companies and investors alike. This report synthesizes recent developments in clinical trials, conducts a comprehensive market analysis, and projects Adreview’s commercial potential over the next five years.


Clinical Trials Update

Current Trial Phases and Outcomes

Adreview is presently progressing through Phase II clinical trials, which commenced in Q4 2021. These trials focus on Mild Cognitive Impairment (MCI) and early Alzheimer’s disease (AD) populations, aiming to evaluate safety, tolerability, and preliminary efficacy. As of Q1 2023, interim data from the trial involving 300 participants indicate promising safety profiles, with adverse events comparable to placebo groups (2%).

Efficacy Signals and Biomarker Results

Preliminary efficacy biomarkers suggest a positive trend: reduced amyloid-beta accumulation, stabilized tau phosphorylation levels, and improvement in cognitive test scores based on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). These results are encouraging, though not yet statistically definitive.

Regulatory Interactions and Future Trials

The sponsor has scheduled meetings with regulatory agencies, including the FDA and EMA, to align on Phase III trial design and accelerated approval pathways. Pending complete Phase II data, plans for a pivotal trial involving approximately 1,200 participants across multiple countries are underway, targeting enrollment completion by late 2024.

Ongoing Challenges

Despite promising signals, challenges remain. The complexities of neurodegenerative disease pathways, high placebo response rates, and the need for long-term efficacy data pose hurdles. Additionally, the novelty of Adreview’s mechanism warrants thorough safety verification in larger populations to preempt adverse effects.


Market Analysis

Global Neurodegenerative Disease Market Overview

The neurodegenerative disease treatment market was valued at approximately USD 15 billion in 2022 and is projected to reach USD 25 billion by 2030, growing at a CAGR of 6.2% (3). Alzheimer’s disease dominates this space, accounting for over 60% of spending. Rising aging populations, increased diagnosis rates, and recent pipeline innovations are primary growth drivers.

Competitive Landscape

Existing therapeutics, primarily cholinesterase inhibitors and NMDA receptor antagonists, address symptoms but lack disease-modifying capabilities. Recently approved drugs such as aducanumab and lecanemab target amyloid plaques, although with debates over clinical benefit and cost-effectiveness.

Adreview’s novel mechanism of neuroinflammation modulation could position it uniquely against amyloid-centric therapies, potentially offering a disease-modifying option with a different safety profile. Major players such as Biogen, Eli Lilly, and Roche are investing heavily in similar targets, emphasizing the competitive nature of the pipeline.

Regulatory Incentives and Market Entry Strategies

Fast-track designations, Breakthrough Therapy status, and potential orphan drug designations could expedite Adreview’s path to market. Strategic partnerships with stakeholder organizations, health authorities, and insurance providers will be critical for broad adoption.

Pricing and Reimbursement Dynamics

Given the significant burden of AD, premium pricing strategies are feasible, contingent on demonstrated clinical superiority and safety. Payers are increasingly demanding robust evidence of long-term benefit, which can influence reimbursement negotiations.


Market Projection for Adreview

Revenue Forecast (2023–2028)

Assuming successful completion of Phase III trials and regulatory approval by 2025, Adreview could capture segments of the early AD treatment market. The projected revenues are as follows:

  • 2023–2024: Pre-market, limited revenue from early access schemes or compassionate use (~USD 50–100 million in reputation-building partnerships).
  • 2025–2026: Launch phase, with initial adoption in US and EU markets, estimated sales of USD 1.2 billion by 2026.
  • 2027–2028: Expanded global penetration, post-launch optimization, estimated sales reaching USD 3.5 billion annually.

This forecast considers potential competitors, regulatory timelines, and reimbursement environments. Market uptake will depend heavily on clinical data robustness, safety profile, and payer acceptance.

Global Reach and Emerging Markets

Emerging markets will be pivotal for volume expansion, especially as healthcare infrastructure improves. Price adjustments and tiered access strategies will facilitate broader access in the Asia-Pacific and Latin America regions.

Future Growth Opportunities

Beyond cognitive impairment indications, exploring Parkinson’s disease, Lewy body dementia, and other neuroinflammatory conditions could catalyze additional revenue streams. Companion diagnostic development and personalized medicine approaches may enhance clinical success rates.


Strategic Recommendations

  • Accelerate Clinical Development: Focus on completing Phase II and initiating Phase III expeditiously to capitalize on unmet needs.
  • Regulatory Engagement: Engage proactively with health authorities for accelerated pathways, including adaptive trial design possibilities.
  • Partnerships: Explore licensing, co-development, and commercialization collaborations with pharma giants to mitigate development costs and expedite market entry.
  • Market Access: Develop strong health economics and outcomes research (HEOR) data to support pricing and reimbursement negotiations.
  • Pipeline Expansion: Secure funding and partnerships for subsequent indications, broadening Adreview’s therapeutic scope.

Key Takeaways

  • Promising Clinical Data: Adreview’s Phase II data suggests safety and early signals of efficacy, positioning it as a potentially transformative neurodegenerative therapy.
  • Market Potential: The neurodegenerative market’s growth trajectory, driven by demographic shifts and pipeline innovations, supports substantial future revenues for Adreview.
  • Competitive Differentiation: Its novel mechanism may confer advantages over existing treatments, especially in disease modification.
  • Regulatory and Commercial Strategy: Focused engagement with regulators and strategic partnerships are essential to minimize development risks and optimize commercial deployment.
  • Long-term Outlook: With successful trial outcomes and regulatory approval, Adreview could secure a leadership role in a multi-billion-dollar marketplace, assuming favorable reimbursement and market penetration.

FAQs

Q1: What distinguishes Adreview from current Alzheimer’s treatments?
A1: Unlike traditional symptomatic therapies, Adreview targets neuroinflammation and synaptic health, aiming to modify disease progression rather than merely alleviate symptoms.

Q2: What are the main risks associated with Adreview’s development?
A2: Risks include failure to demonstrate statistically significant efficacy, unforeseen adverse effects, delays in regulatory approval, and competitive pressure from other pipeline candidates.

Q3: When is Adreview expected to reach the market?
A3: Pending successful Phase III trials and regulatory approval, the earliest launch could occur by 2025–2026.

Q4: How might pricing influence Adreview’s market adoption?
A4: High efficacy and safety could support premium pricing, but payers will require robust long-term data to justify reimbursement levels.

Q5: What are potential future indications for Adreview?
A5: Besides early AD, potential applications include Parkinson’s disease, Lewy body dementia, and other neuroinflammatory and neurodegenerative disorders.


References

  1. ClinicalTrials.gov. Adreview Phase II trial data, accessed March 2023.
  2. Internal trial reports and interim results, sponsor disclosures, 2023.
  3. Market Watch: Neurodegenerative Disease Therapeutics Outlook, 2022.
  4. GlobalData: Alzheimer’s Disease Market Analysis, 2022.

Conclusion

Adreview represents a promising entrant in the neurodegenerative therapeutics landscape. Its progression through clinical development stages aligns with an expanding market eager for disease-modifying options. Strategic execution, robust clinical validation, and proactive regulatory engagement will be decisive determinants of its commercial success in the coming years.

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