CLINICAL TRIALS PROFILE FOR IOHEXOL

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.
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	GE Healthcare	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.

Clinical Trial Conditions for iohexol

Condition Name

Condition Name for iohexol
Intervention	Trials
Healthy	7
Acute Kidney Injury	4
Diabetic Nephropathies	3
Hiv	3

Condition MeSH

Condition MeSH for iohexol
Intervention	Trials
Kidney Diseases	9
Renal Insufficiency	8
Acute Kidney Injury	5
Coronary Artery Disease	4

Clinical Trial Locations for iohexol

Trials by Country

Trials by Country for iohexol
Location	Trials
United States	102
France	10
Canada	8
Italy	5
Spain	3

Trials by US State

Trials by US State for iohexol
Location	Trials
California	12
New York	5
Michigan	5
Maryland	4
Utah	4

Clinical Trial Progress for iohexol

Clinical Trial Phase

Clinical Trial Phase for iohexol
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for iohexol
Clinical Trial Phase	Trials
Completed	34
RECRUITING	17
Not yet recruiting	10

Clinical Trial Sponsors for iohexol

Sponsor Name

Sponsor Name for iohexol
Sponsor	Trials
Eli Lilly and Company	5
National Cancer Institute (NCI)	4
Alessandro Doria	3

Sponsor Type

Sponsor Type for iohexol
Sponsor	Trials
Other	100
Industry	33
NIH	11

Clinical Trials Update, Market Analysis, and Projection for Iohexol

Last updated: October 27, 2025

Introduction

Iohexol, a non-ionic, iodine-based contrast agent primarily used in radiographic imaging procedures, has maintained a significant role in diagnostic medicine since its introduction. As healthcare advances towards precision imaging, understanding the current clinical trial landscape, market trajectory, and future outlook for Iohexol is critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Clinical Trials Overview

Ongoing and Recent Clinical Trials

Iohexol’s safety and efficacy profile has been well-established in decades of use. However, recent clinical trials focus on optimizing its administration, reducing adverse reactions, and exploring novel applications. Major trial registries, such as ClinicalTrials.gov, indicate active research in the following domains:

• Adverse Reaction Minimization: Several studies aim to refine dosage regimens and premedication protocols to decrease the incidence of contrast-induced nephropathy (CIN), particularly in vulnerable populations like those with pre-existing renal impairment [1].
• Expanded Diagnostic Applications: Trials are evaluating Iohexol’s utility in advanced imaging techniques, including intraoperative imaging and dynamic perfusion studies, enhancing its versatility [2].
• Comparative Effectiveness: Some comparative studies examine Iohexol against newer contrast agents regarding image quality, safety, and cost-effectiveness, illustrating ongoing efforts to solidify its competitive edge.

Regulatory Status and Market Approvals

Iohexol has obtained regulatory approval from agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), with ongoing post-marketing surveillance to monitor long-term safety. No significant recent indications for new formulations or delivery methods have been announced, but modifications aimed at improving biocompatibility and reducing side effects are under clinical evaluation.

Market Analysis

Market Size and Segments

The global contrast media market, valued at approximately USD 4.3 billion in 2022, is projected to reach around USD 6.4 billion by 2030, growing at a CAGR of 5.4% [3]. Iohexol remains a leading product segment within this market, owing to its widespread acceptance for computed tomography (CT) scans.

Regional Presence:

• North America: Dominates due to high healthcare expenditure, advanced imaging infrastructure, and extensive clinical use.
• Europe: Represents a significant share, supported by aging populations and increased diagnostic procedures.
• Asia-Pacific: Exhibiting rapid growth driven by expanding healthcare access, emerging economies, and increased adoption of diagnostic imaging.

Drivers and Challenges

Drivers:

• Increasing prevalence of chronic diseases necessitating diagnostic imaging.
• Technological advancements making imaging more accessible and accurate.
• Growing awareness about early diagnosis contributing to higher contrast media usage.

Challenges:

• Concerns over contrast-induced nephropathy and allergic reactions restrict use in high-risk groups.
• Competition from gadolinium-based agents and newer iodinated contrast agents with improved safety profiles.
• Regulatory scrutiny and safety concerns influence prescribing practices.

Competitive Landscape

Major players include GE Healthcare, Bayer AG (which manufactures Iohexol under the brand name Omnipaque), Bracco Diagnostics, and Guerbet. Bayer’s Iohexol dominates in volume due to strong brand recognition and a broad distribution network.

Market Projection and Future Outlook

Growth Factors

The demand for traditional iodinated contrast agents like Iohexol is expected to remain stable, supported by ongoing clinical applications in routine imaging and interventional procedures. Innovation avenues such as customizable formulations, reduced osmolality, and targeted delivery systems could boost future adoption rates.

Potential for Product Differentiation

While Iohexol’s core remains unchanged, investments in developing formulations with lower osmolality and reduced adverse events could expand its use in high-risk populations, particularly in patients with renal impairment or allergies. Furthermore, integrating Iohexol into hybrid imaging modalities like PET/CT could unlock new markets.

Impact of Regulatory Trends and Digital Health Integration

Regulatory agencies emphasize safety, which may lead to stricter guidelines on contrast media use. However, digital health and AI-powered imaging analytics may improve contrast agent benchmarking, fostering confidence and expanding applications.

Conclusion

Iohexol continues to occupy a vital niche within the contrast media market, supported by extensive clinical validation and widespread clinical application. While newer agents and concerns about safety pose challenges, ongoing clinical innovation and strategic positioning enable Iohexol to sustain its relevance. The future landscape points toward incremental growth driven by technological enhancements, expanded indications, and targeted formulations tailored to high-risk groups.

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Key Takeaways

• Clinical Trials: Ongoing research focuses on safety optimization, expanded diagnostic roles, and comparative effectiveness, promising incremental improvements in Iohexol’s profile.
• Market Dynamics: The contrast media market is robust, with Iohexol maintaining a significant share, especially within CT imaging. Growth is supported by aging populations and technological advancements.
• Future Outlook: Iohexol’s prospects hinge on reformulations that enhance safety, broaden applications, and integrate with emerging imaging technologies. The competitive landscape remains strong but faces challenges from newer agents and safety concerns.
• Regulatory Environment: Stricter safety protocols may influence prescribing patterns but also open avenues for formulation innovations and personalized medicine approaches.
• Strategic Opportunities: Aligning product development with safety profiles, expanding indications, and leveraging digital health integrations can bolster Iohexol’s market position.

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FAQs

1. What are the recent advancements in clinical trials involving Iohexol?
Recent trials primarily focus on reducing adverse reactions, expanding diagnostic applications, and comparing its efficacy and safety against newer contrast agents. Studies also examine optimized dosing protocols in vulnerable patient groups.

2. How does Iohexol’s safety profile compare to other contrast media?
Iohexol is considered safe with a low incidence of adverse effects. However, it still poses risks of contrast-induced nephropathy and allergic reactions, similar to other iodinated agents. New formulations aim to mitigate these concerns further.

3. What markets are expected to drive future demand for Iohexol?
Growth will primarily come from North America and Europe due to high diagnostic imaging volumes, with Asia-Pacific presenting emerging opportunities owing to expanding healthcare infrastructure and diagnostic access.

4. Are there any regulatory challenges facing Iohexol?
Regulatory agencies are increasingly scrutinizing contrast agents' safety, especially concerning nephrotoxicity and allergic reactions. New formulations with improved safety profiles are in development to address these challenges.

5. What are the innovation prospects for Iohexol in the next decade?
Potential innovations include low-osmolality formulations, targeted delivery systems, combination with digital imaging enhancements, and expanded indications such as interventional or intraoperative imaging, all aimed at improving safety and utility.

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Sources

[1] ClinicalTrials.gov, "Contrast Agent Safety Trials," 2022.
[2] Journal of Diagnostic Imaging, "Emerging Applications of Iohexol," 2021.
[3] MarketsandMarkets, "Contrast Media Market Analysis," 2022.