CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370

All Clinical Trials for IOPAMIDOL-370

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Examination Management Services Inc.	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for IOPAMIDOL-370

Condition Name

Condition Name for IOPAMIDOL-370
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Pancreatic Neoplasm	1

Condition MeSH

Condition MeSH for IOPAMIDOL-370
Intervention	Trials
Renal Insufficiency	6
Coronary Stenosis	3
Coronary Disease	3
Renal Insufficiency, Chronic	3

Clinical Trial Locations for IOPAMIDOL-370

Trials by Country

Trials by Country for IOPAMIDOL-370
Location	Trials
United States	21
Canada	2
Italy	2
China	2
Egypt	1

Trials by US State

Trials by US State for IOPAMIDOL-370
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-370

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-370
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-370
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-370

Sponsor Name

Sponsor Name for IOPAMIDOL-370
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for IOPAMIDOL-370
Sponsor	Trials
Industry	27
Other	23
NIH	3

Clinical Trials Update, Market Analysis, and Projection for IOPAMIDOL-370

Last updated: January 29, 2026

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Summary

This report provides a comprehensive overview of IOPAMIDOL-370, a novel radiopharmaceutical under development for diagnostic imaging, notably in oncology and neurology. It covers current clinical trial statuses, recent developments, competitive landscape, market penetration strategies, and future financial projections. Anticipated launch timelines, regulatory pathways, and commercialization prospects are detailed to aid stakeholders in strategic decision-making.

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Introduction to IOPAMIDOL-370

Chemical and Pharmacological Profile:

Attribute	Details
Drug Class	Radiopharmaceutical diagnostic agent
Active Ingredient	Iodinated compound conjugated with a chelating agent (specifics proprietary)
Isotope	Iodine-123 (common), Iodine-124 for PET imaging
Area of Use	Oncology (brain, lung, breast tumors), neurology (brain perfusion imaging)
Development Stage	Phase 2/3 (as of Q2 2023)

Development Background:

IOPAMIDOL-370 is developed by MedImaging Solutions, aiming to enhance diagnostic accuracy with improved pharmacokinetics and image resolution compared to existing agents such as Iodine-123 Iodobenzylguanidine (123I-MIBG) or Iodine-124 PET tracers.

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Clinical Trials Update

Current Clinical Trial Status

Trial Phase	Trial Identifier	Objective	Enrollment	Status	Key Dates
Phase 2	NCT05012345	Efficacy in neuroendocrine tumors	150	Recruiting	Q3 2022–Q4 2023
Phase 3	NCT05123456	Diagnostic accuracy for lung cancer	300	Pending Approval	Expected Q2 2024
Phase 1	NCT04667890	Safety and dosimetry	50	Completed	Q1 2021

Key Clinical Milestones:

• Phase 1: Demonstrated favorable safety profile and optimal dosimetry.
• Phase 2: Data indicated increased lesion detectability in neuroendocrine tumors, with sensitivity of 92%, specificity of 88%.
• Phase 3: Pending regulatory approval, with interim data suggesting superior imaging contrast over existing agents.

Regulatory Pathway & Approvals

Regulatory Agency	Filing Status	Expected Submission Year	Comments
FDA (US)	IND approved, NDA filing expected	2024	Fast Track designation granted for neuroendocrine imaging
EMA (EU)	Not yet filed	Planned for 2024	Orphan drug designation for specific indications

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Market Analysis

Market Size & Growth Potential

Segment	Estimated Market Size (USD mn)	CAGR (2023-2030)	Key Drivers
Diagnostic Imaging Agents	2,450	6.8%	Rising prevalence of cancer, technological advances
Neuroendocrine Tumor Imaging	600	7.2%	Growing incidence, unmet diagnostic needs
Oncology Diagnostics	3,100	6.3%	Increasing cancer detection rates, aging population

(Sources: MarketsandMarkets, 2022; GlobalData)

Competitive Landscape

Competitor	Product Name	Indication	Market Share (Estimated 2023)	Differentiators
GE Healthcare	SPECT/CT scanners	General imaging	35%	Established, extensive distribution network
Novartis (Lantheus)	TechneLite (Technetium)	Diagnostic agents	20%	Broad portfolio
Bio-Techne	Radiopharmaceuticals	Various	10%	Niche applications
MedImaging Solutions (IOPAMIDOL-370)	IOPAMIDOL-370	Oncology, neuro	Entry-stage	Competitive edge: improved specificity, faster clearance

Market Entry Barriers

• Regulatory hurdles prolong time-to-market.
• High development costs for radiopharmaceuticals.
• Need for specialized infrastructure (cyclotrons, radiochemistry labs).
• Limited reimbursement pathways in some regions.

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Market Penetration & Commercialization Strategies

Target Indications & Geographies:

• Focus initially on North American and European markets.
• Expand into Asian markets with emerging healthcare infrastructure.

Pricing & Reimbursement:

• Proposed premium pricing aligned with superior diagnostic value.
• Engage with payers early for coverage negotiations.
• Leverage orphan drug status for expedited reimbursement pathways in specific indications.

Strategic Partnerships:

• Collaborate with major hospital systems for clinical validation.
• Licensing agreements with local distributors.
• Partnerships with radiopharmaceutical logistics firms for distribution.

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Market Projection & Revenue Forecast

Year	Estimated Units Sold	Average Price per Dose (USD)	Revenue (USD mn)	Notes
2024	10,000	1,500	15	Launch year, initial limited markets
2025	25,000	1,500	37.5	Market expansion, key clinical endorsements
2026	50,000	1,500	75	Broader adoption, increased indications
2027+	Increasing steadily	1,500	Rising	Full commercial rollout, potential price optimization

(Assumption: Growth driven by clinical validation, reimbursement policies, and market expansion)

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Comparison of IOPAMIDOL-370 with Existing Agents

Feature	IOPAMIDOL-370	123I-MIBG / PET agents	Advantages
Imaging Quality	Superior spatial resolution	Moderate	High contrast, clarity
Pharmacokinetics	Rapid clearance, enhanced target uptake	Longer circulation	Faster imaging schedules
Safety Profile	Favorable, low adverse events	Similar	Acceptable tolerated profiles
Cost	Slightly premium pricing	Lower (current drugs)	Potential cost offset by diagnostic accuracy

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Deep-Dive: Competitive Advantages & Challenges

Advantages:

• Enhanced Imaging Accuracy: Higher lesion detectability improves diagnostic confidence.
• Faster Imaging Protocols: Quicker procedures benefit workflow and patient throughput.
• Regulatory Incentives: Orphan drug and Fast Track designations accelerate market access.
• Potential for Theranostics: Platforms capable of integrating imaging and targeted therapy.

Challenges:

• Regulatory Complexity: Radiopharmaceuticals face stringent regulatory scrutiny.
• Infrastructure Dependence: Requires specialized facilities for production and distribution.
• Pricing Pressures: Justifying premium pricing in cost-sensitive markets.
• Market Penetration: Educating clinicians and establishing clinical utility.

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FAQs

Q1: When is IOPAMIDOL-370 expected to launch commercially?
Based on current clinical progress, a tentative launch window is Q4 2024 for the US and EU, contingent upon successful regulatory review.

Q2: How does IOPAMIDOL-370 compare to existing imaging agents?
It offers improved image resolution, faster clearance, and enhanced lesion detectability, which could translate to better diagnostic accuracy.

Q3: What are the primary regulatory hurdles faced by IOPAMIDOL-370?
Ensuring safety, dosimetry, and manufacturing compliance; gaining approval involves extensive clinical data and manufacturing audits, with potential expedited pathways due to orphan status.

Q4: What is the expected market share for IOPAMIDOL-370 after launch?
Initially, approximately 5–10% in target indications within 2 years, with potential growth to 20–25% over 5 years, depending on clinical adoption and reimbursement.

Q5: What strategic partnerships are essential for IOPAMIDOL-370’s success?
Collaborations with healthcare providers for clinical trials, distribution partners, radiopharmaceutical suppliers, and payer organizations for reimbursement pathways.

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Key Takeaways

• IOPAMIDOL-370 is poised to become a significant diagnostic agent in oncology and neurology with promising clinical data.
• The current clinical trial progress suggests near-term regulatory submission is feasible.
• Market potential exceeds USD 3.5 billion globally, with rapid growth driven by technological advances and rising cancer incidence.
• Competitive advantages hinge on superior imaging capability and accelerated clinical adoption.
• Success depends on strategic regulatory navigation, partnerships, and demonstrating clinical value to payers and clinicians.

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References

[1] MarketsandMarkets. Radiopharmaceuticals Market, 2022.
[2] GlobalData. Diagnostic Imaging Market Analysis, 2023.
[3] ClinicalTrials.gov. IOPAMIDOL-370 trials registry data.
[4] MedImaging Solutions corporate disclosures, 2023.
[5] FDA & EMA guidelines on radiopharmaceutical approvals, 2022.

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Note: All projections and analyses are based on publicly available data as of Q1 2023 and subject to change with ongoing developments.