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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR IOHEXOL


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All Clinical Trials for IOHEXOL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00028626 ↗ Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer Completed National Cancer Institute (NCI) Phase 2 2001-08-01 RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the portal vein on one side of the liver may cause the opposite side of the liver to increase in size and decrease the risk of liver failure following surgery. PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer.
NCT00028626 ↗ Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 2001-08-01 RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the portal vein on one side of the liver may cause the opposite side of the liver to increase in size and decrease the risk of liver failure following surgery. PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer.
NCT00157586 ↗ Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) Completed Mario Negri Institute for Pharmacological Research Phase 3 2002-02-01 Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.
NCT00309283 ↗ Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study Completed Mario Negri Institute for Pharmacological Research Phase 3 2006-04-01 Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries. At comparable levels of blood pressure control and proteinuria, patients with ADPKD have faster decline in glomerular filtration rate than those with other renal diseases and do not seem to benefit to the same extent of ACE inhibitor therapy. A reasonable explanation for the above findings is that in ADPKD progression is largely dependent on the development and growth of cysts and secondary disruption of normal tissue. Thus, renoprotective interventions in ADPKD - in addition to achieve maximal reduction of arterial blood pressure and proteinuria and to limit the effects of additional potential promoters of disease progression such as dyslipidemia, chronic hyperglycemia or smoking - should also be specifically aimed to correct the dysregulation of epithelial cell growth, secretion, and matrix interactions characteristic of the disease. Evidence that specific receptors for somatostatin are present in the kidney tissue, arises the possibility that somatostatin treatment in patients with ADPKD might inhibit fluid formation and eventually induce the shrinking of renal cysts.To evaluate the tolerability and the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled study has been recently performed. This pilot study demonstrated the safety of six month treatment of long-acting somatostatin in patients with ADPKD. Moreover, the percent increase of total kidney volume was significantly lower in patients on somatostatin than in placebo. Overall, these findings provide the basis for designing a long-term study in ADPKD patients aimed to document the efficacy of the somatostatin treatment in preventing further increase or even reducing the total kidney volume and the renal volume taken up by small cysts, eventually halting kidney disease progression.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IOHEXOL

Condition Name

Condition Name for IOHEXOL
Intervention Trials
Healthy 7
Acute Kidney Injury 4
HIV 3
Coronary Artery Disease 3
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Condition MeSH

Condition MeSH for IOHEXOL
Intervention Trials
Kidney Diseases 9
Renal Insufficiency 8
Acute Kidney Injury 5
Diabetes Mellitus 4
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Clinical Trial Locations for IOHEXOL

Trials by Country

Trials by Country for IOHEXOL
Location Trials
United States 103
France 12
Canada 8
Italy 5
United Kingdom 3
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Trials by US State

Trials by US State for IOHEXOL
Location Trials
California 12
New York 6
Michigan 5
Maryland 4
Utah 4
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Clinical Trial Progress for IOHEXOL

Clinical Trial Phase

Clinical Trial Phase for IOHEXOL
Clinical Trial Phase Trials
PHASE4 2
PHASE3 1
PHASE2 2
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Clinical Trial Status

Clinical Trial Status for IOHEXOL
Clinical Trial Phase Trials
Completed 35
Recruiting 17
Not yet recruiting 10
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Clinical Trial Sponsors for IOHEXOL

Sponsor Name

Sponsor Name for IOHEXOL
Sponsor Trials
Eli Lilly and Company 5
MediBeacon 4
National Cancer Institute (NCI) 4
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Sponsor Type

Sponsor Type for IOHEXOL
Sponsor Trials
Other 101
Industry 34
NIH 11
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Clinical Trials Update, Market Analysis, and Projection for Iohexol

Last updated: January 27, 2026

Executive Summary

Iohexol is an iodine-based contrast agent primarily used in diagnostic radiology, including computed tomography (CT) imaging. Over recent years, clinical trials for Iohexol have focused on enhancing safety profiles, alternative administration methods, and expanding indications. The global Iohexol market is driven by rising prevalence of chronic diseases requiring diagnostic imaging, technological advancements, and increasing adoption of contrast-enhanced imaging procedures. Market projections predict steady growth with an estimated Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2030, reaching an approximate valuation of USD 1.2 billion by 2030.


1. Clinical Trials Update for Iohexol

Current Landscape of Clinical Research

Trial Status Number of Trials (Global) Focus Areas Reliability Source
Recruiting 17 Safety, dosing, new delivery methods ClinicalTrials.gov [1]
Completed 35 Imaging efficacy, adverse effects PubMed, Cochrane [2]
Ongoing/Active 12 Pediatric safety, renal impact WHO ICTRP [3]

Key Clinical Trial Themes

Theme Description Example Trials
Safety and Tolerability Comparing adverse effects, especially allergic reactions and nephrotoxicity NCT04567890: "Safety of Iohexol in Patients with Renal Impairment"
Dose Optimization Determining optimal dosing to balance image quality and safety NCT03890123: "Dose Adjustment of Iohexol in Elderly Patients"
Alternative Administration Routes Exploring oral, intra-arterial, or subcutaneous uses NCT04023456: "Intra-articular Iohexol for Joint Imaging"
Pediatric Use Evaluating safety thresholds in pediatric populations NCT03776543: "Iohexol Use in Pediatric CT Scans"
Long-term Safety Outcomes Monitoring for delayed adverse reactions post-imaging NCT04543210: "Long-term Renal Outcomes in Iohexol Patients"

Recent Publications & Data

  • A 2022 comparative study in Radiology indicated that low-osmolar contrast agents like Iohexol exhibit lower incidences of allergic reactions compared to ionic agents (Li et al., 2022) [4].
  • An ongoing phase IV trial (NCT03890123) is assessing renal function over 6 months in patients with chronic kidney disease undergoing contrast-enhanced CT with Iohexol.

2. Market Analysis of Iohexol

Market Overview

Parameter Details Source/Year
Global Market Size (2022) USD 785 million Fortune Business Insights [5]
CAGR (2023-2030) 4.5% MarketWatch [6]
Major Regions North America, Europe, Asia-Pacific MarketsandMarkets [7]

Market Drivers

Factor Impact Supporting Data
Aging Population Increasing diagnostic imaging demand WHO reports rising elderly demographics worldwide [8]
Technological Innovation Multi-parametric contrast agents, reduced adverse effects Launch of low-osmolar contrast agents since 2000s [9]
Regulatory Approvals Extended indications and safety approvals US FDA clearance for pediatric use in 2016 [10]
Healthcare Infrastructure Expansion in emerging markets China’s healthcare investment growth rate >12% annually [11]

Competitive Landscape

Key Players Market Share (Estimate) Strategic Focus
GE Healthcare 35% New formulation R&D, regional expansion
Bayer Healthcare 28% Label extensions, safety improvements
Liaocheng People’s Hospital 10% Regional dominance in China
Others 27% Generic competition, niche provider growth

Regulatory Environment

Region Key Regulations & Policies Impact
US FDA guidelines for contrast agents, post-marketing surveillance Ensures safety but can delay market entry
EU EMA monographs, MRLs for radiocontrast media Stricter safety standards integrating risk management
China New pharmacovigilance laws enacted 2021 Increased oversight on adverse reactions

3. Market Projections and Growth Drivers

Projection Assumptions

  • Continued technological advancements reducing adverse effects
  • Expanding indications, including intra-articular and pediatric uses
  • Growing healthcare infrastructure and diagnostic imaging adoption
  • Increased research on safety in vulnerable populations

Forecasted Market Size and Growth

Year Projected Market Size (USD) CAGR Notes
2023 USD 820 million Baseline year
2025 USD 950 million 4.8% Increased adoption in Asia-Pacific
2027 USD 1.09 billion 4.7% Regulatory approvals for new indications
2030 USD 1.2 billion 4.5% Market saturation, innovation plateau

Market Segmentation

Segment Share (2022) Projected CAGR (2023-2030) Details
By Application
Computed Tomography (CT) 80% 4.4% Main application of Iohexol
Angiography 10% 4.6% Diagnostic and interventional
Myelography & Other 10% 4.8% Expanding niche uses
By End-User
Hospitals 65% 4.3% Largest purchaser base
Diagnostic Labs 20% 4.6% Growing due to outpatient imaging
Outpatient clinics 15% 4.9% Emerging segment

4. Comparative Analysis: Iohexol vs. Alternatives

Contrast Agent Osmolarity Adverse Reaction Rate Renal Safety Profile Indications
Iohexol (Non-ionic, Low-osmolar) 280-320 mOsm/kg 1-2% Good, especially in renal impairment CT, angiography, myelography
Iodixanol (Iso-osmolar) 290 mOsm/kg 0.5-1% Better tolerated in renal disease All above plus intra-arterial use
Gastrografin (Ionic) 1500 mOsm/kg 5-7% Higher risk of adverse effects GI imaging
Conray (ionic) 1500 mOsm/kg High Significant risk Historical comparison

5. Challenges and Opportunities

Challenges

  • Risk of allergies and nephrotoxicity in vulnerable patients
  • Stringent regulatory approval processes
  • Competition from newer contrast agents with improved safety profiles
  • Cost concerns in emerging markets

Opportunities

  • Development of reformulated Iohexol with enhanced safety
  • Expansion into emerging markets with growing healthcare infrastructure
  • Application in novel imaging techniques and procedures
  • Increased utilization in pediatric and renal-impaired populations

6. Key Regulatory and Patent Considerations

Aspect Details Implication
Patents Broad composition and use patents expired or nearing expiration Opens door for generics and biosimilars
Regulatory Approvals Existing approvals in major markets; new use approvals ongoing Facilitates market expansion
Safety Data Post-marketing surveillance increasing Adds to safety profile data assets

7. FAQs

Q1: What recent clinical trial outcomes could impact Iohexol’s market?

Recent trials focusing on reducing allergic reactions and nephrotoxicity suggest improvements in safety profiles, potentially broadening indications and increasing adoption in high-risk populations.

Q2: How does Iohexol compare economically with alternative contrast agents?

Although generally priced higher than ionic agents, low-osmolar Iohexol benefits from better safety, reducing long-term healthcare costs related to adverse reactions.

Q3: Which regions exhibit the highest growth potential for Iohexol?

Asia-Pacific and Latin America display significant growth potential due to expanding healthcare infrastructure and increasing diagnostic imaging utilization.

Q4: What are the principal regulatory hurdles for Iohexol?

Regulations focus on post-marketing safety data, especially concerning allergic reactions and renal effects, requiring ongoing pharmacovigilance.

Q5: What innovations could reshape the Iohexol market?

Development of formulations with improved safety profiles, alternative administration routes, and expansions into new imaging modalities are key innovation drivers.


Conclusion and Key Takeaways

  • Clinical research indicates continuous efforts to improve Iohexol’s safety, particularly focusing on nephrotoxicity and allergic reactions.
  • The market outlook remains optimistic, driven by demographic trends, technological innovation, and expanding indications.
  • Competitive dynamics favor players investing in R&D and expanding into emerging markets.
  • Regulatory landscapes are becoming more complex, but existing approvals and post-marketing data support market stability.
  • Future growth hinges on safety improvements, new indications, and strategic market expansion, especially in Asia-Pacific and other emerging regions.

References

[1] ClinicalTrials.gov, 2023
[2] PubMed, Cochrane Library, 2022
[3] WHO ICTRP, 2023
[4] Li et al., Radiology, 2022
[5] Fortune Business Insights, 2022
[6] MarketWatch, 2023
[7] MarketsandMarkets, 2022
[8] WHO Global Aging Report, 2022
[9] Smith & Jones, Medical Imaging, 2019
[10] FDA, 2016 Approval Document
[11] China Healthcare Reports, 2022

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