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.
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	University of Alabama at Birmingham	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.
NCT00497328 ↗	COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT	Completed	National University Hospital, Singapore	Phase 2/Phase 3	2007-08-01	This is a randomised controlled trial to investigate the efficacy of preventive regimen of hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR 15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD formula)) undergoing elective percutaneous coronary intervention (PCI).

Clinical Trial Conditions for iohexol

Condition Name

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

Condition MeSH

Condition MeSH for iohexol
Intervention	Trials
Kidney Diseases	9
Renal Insufficiency	8
Acute Kidney Injury	5
Diabetes Mellitus	4

Clinical Trial Locations for iohexol

Trials by Country

Trials by Country for iohexol
Location	Trials
United States	103
France	12
Canada	8
Italy	5
Germany	3

Trials by US State

Trials by US State for iohexol
Location	Trials
California	12
New York	6
Michigan	5
Ohio	4
Texas	4

Clinical Trial Progress for iohexol

Clinical Trial Phase

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

Clinical Trial Status

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

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

Sponsor Type

Sponsor Type for iohexol
Sponsor	Trials
Other	101
Industry	34
NIH	11

Iohexol Clinical Trials Update, Market Analysis, and Projection (2024-2035)

Last updated: April 27, 2026

What is iohexol and how is it used clinically?

Iohexol is a non-ionic, water-soluble iodinated contrast medium used for intravascular and intrathecal imaging, including computed tomography (CT), angiography, and related radiology applications. It is an established small-molecule drug with decades of clinical use, and it is widely supplied as branded and generic products across major markets (US, EU, Japan, and others).

In practice, iohexol competes in the same radiocontrast segment as other iodinated agents (e.g., iopamidol, ioversol, iomeprol) with differentiation based on concentration, osmolality, viscosity, dosing regimes, delivery formats, and patient safety outcomes in specific clinical workflows.

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What clinical trial activity is currently observable for iohexol?

Iohexol’s trial footprint in recent years is dominated by:

• Formulation and supply-chain continuity (stability, packaging, shelf-life, and related quality studies).
• Protocol comparisons where iohexol is an active comparator rather than the primary investigational drug (e.g., imaging protocol optimization).
• Non-registrational studies focused on imaging accuracy, contrast kinetics, and real-world workflow outcomes.

Important market reality: For a long-established contrast agent like iohexol, many “clinical trials updates” in public databases are either (a) small procedural studies or (b) studies where iohexol is a control arm. That limits the ability to translate trial counts into a direct forward-looking product value driver.

Clinical trial indexing note: The standard way to track this activity is ClinicalTrials.gov and EudraCT/EMA-linked records. Public visibility is uneven across geographies, and procedural comparator studies are often not clearly separated from broader diagnostic trials.

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What does the market look like for iodinated contrast media, and where does iohexol sit?

Market segmentation by product class

The iodinated contrast media market divides into:

• Non-ionic, low-osmolality iodinated contrast media (mainstream standard in most modern CT/angiography workflows).
• Legacy ionic formulations (smaller and declining).

Iohexol is part of the non-ionic class and typically sold in multiple strengths (commonly 240 mgI/mL and 300 mgI/mL for many CT uses; additional strengths and indications vary by region and product line).

Competitive set

Iohexol’s main commercial competitive set in CT/angiography includes:

• iopamidol
• ioversol
• iomeprol
• iodixanol (non-ionic but osmolality/chemistry differs and clinical preference varies by setting)

Where iohexol wins commercially is usually not about “new science.” It is about:

• supply reliability and tender performance,
• inventory planning for hospital formularies,
• price-to-performance in national health procurement,
• availability of clinically acceptable concentrations and delivery formats.

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What are the key regulatory and safety constraints shaping demand?

Safety profile as a procurement anchor

Iodinated contrast use is constrained by:

• risk management around contrast-associated acute kidney injury (CA-AKI),
• hypersensitivity risk and premedication protocols in higher-risk populations,
• adherence to dose optimization and imaging appropriateness.

Procurement committees typically prefer products with consistent packaging, predictable supply, and established labeling for use conditions.

Clinical guidelines influence

Radiology and nephrology guidance across regions pushes standardized hydration, risk stratification, and imaging selection. That tends to:

• maintain stable demand for the non-ionic segment,
• reduce variability in preferred agents within hospital systems.

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How does patent status affect iohexol’s growth profile?

Iohexol is not a typical “patentable innovation” story because it is a mature compound with multiple generics globally. The practical growth path for branded or incumbent suppliers is driven by:

• manufacturing scale,
• distribution reach,
• formulation line expansions,
• tender cycles,
• discontinuation risk management and portfolio continuity.

As a result, market value growth tracks more closely to:

• imaging volume growth (CT expansion, angiography access),
• patient population growth,
• healthcare spending and procurement modernization,
• replacement of ionic agents by non-ionic products.

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Market analysis and projection: what to model (2024-2035)

Demand drivers

Core demand drivers for iodinated contrast media include:

• continued growth in CT utilization volume,
• expansion of interventional radiology and cardiology imaging,
• aging populations and higher imaging throughput,
• substitution dynamics within non-ionic agents based on tender economics.

Key risks

• price pressure from generics and aggressive tendering,
• supply disruptions (raw material and manufacturing constraints),
• tighter use criteria that reduce repeat scans,
• reputational and utilization risk from adverse event scrutiny.

Projection framing for iohexol specifically

Without a unique mechanism or registrational expansion path, iohexol’s projection should be modeled as: 1) Segment growth (iodinated contrast overall)
2) Share stability or modest share gains/losses based on procurement economics
3) Price erosion typical for generics and older branded molecules

A practical planning model is to project:

• total iodinated contrast market growth,
• apply a non-ionic share,
• apply iohexol’s market share trend,
• apply average selling price (ASP) erosion assumptions.

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Quantitative projection framework (template using measurable levers)

Use this structure for investor-grade modeling:

Lever	Directional assumption (base case)	What it means for iohexol
Imaging volume (CT/angiography)	Up	Higher throughput supports baseline volume growth
Non-ionic share	Stable to up	Keeps iodinated demand in the modern standard class
Iohexol share	Flat to slightly down	Tenders may rotate share among low-osmolality agents
ASP trend	Down	Margin compression from generic competition
Reimbursement/tender intensity	Stable to tougher	Drives pricing and contracting cadence

Because iohexol is mature, the most sensitive projection variables are share shifts and ASP erosion, not “clinical success.”

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Investment and R&D implications: what matters next

Where the next value creation usually comes from

For a mature contrast agent, “next” is rarely a new indication. It is operational and commercial:

• maintaining supply consistency and short lead times,
• winning large tenders through pricing and reliability,
• expanding or optimizing formats for hospital workflow,
• minimizing disruption risk in manufacturing.

How clinical trial updates should be interpreted

Trial publications or registry entries involving iohexol typically:

• support protocol standardization,
• generate incremental evidence for specific workflow endpoints,
• strengthen labeling or clinician comfort where outcomes comparisons exist.

They generally do not change the competitive landscape enough to override generic price pressure unless the trial is tied to a regulator-recognized change or a high-stakes procurement guideline shift.

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Key Takeaways

• Iohexol is a mature iodinated, non-ionic contrast agent with demand tied to imaging volume and procurement economics more than to new clinical mechanism breakthroughs.
• Clinical trial activity is likely dominated by comparator and procedural protocol studies rather than registrational expansion.
• Market value growth is primarily constrained by price erosion and generic competition, while volume tracks CT and interventional imaging utilization.
• Base-case projections should model ASP decline and modest share drift rather than assume step-change market growth from pipeline success.
• Commercial advantage is operational: supply reliability, tender execution, and product-format consistency.

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FAQs

1) Is iohexol still actively used in major diagnostic imaging?
Yes. It remains a widely used iodinated contrast medium for CT and related radiology indications, supplied across major geographies as branded and generic products.

2) Do new clinical trials for iohexol usually lead to major regulatory changes?
Most visible trial activity is procedural or comparator-led, so it typically supports practice standards rather than triggering broad new-label expansions.

3) What drives iohexol revenue most: volume or price?
Revenue is usually more sensitive to pricing (tender economics and generic competition) while unit volume tracks imaging procedure volumes.

4) Who are iohexol’s main commercial competitors?
Other non-ionic iodinated contrast media used in similar imaging settings, including iopamidol, ioversol, iomeprol, and competing non-ionic formulations used across CT and angiography.

5) What should investors watch to forecast iohexol performance?
Tender share changes, ASP trends, supply reliability signals, and any guideline procurement shifts affecting contrast medium selection.

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References

[1] ClinicalTrials.gov. (n.d.). Iohexol studies. https://clinicaltrials.gov/
[2] European Medicines Agency (EMA). (n.d.). Public assessment reports and product information for iodinated contrast media and related active substances. https://www.ema.europa.eu/
[3] American College of Radiology (ACR). (n.d.). Manual on Contrast Media. https://www.acr.org/Clinical-Resources/Contrast-Manual