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Last Updated: February 12, 2025

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.
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).
>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
Coronary Artery Disease 3
Diabetic Nephropathies 3
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Condition MeSH

Condition MeSH for Iohexol
Intervention Trials
Kidney Diseases 9
Renal Insufficiency 8
Acute Kidney Injury 5
Coronary Artery Disease 4
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Clinical Trial Locations for Iohexol

Trials by Country

Trials by Country for Iohexol
Location Trials
United States 93
France 10
Canada 8
Italy 5
Spain 3
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Trials by US State

Trials by US State for Iohexol
Location Trials
California 10
New York 5
Colorado 4
Minnesota 4
Maryland 4
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Clinical Trial Progress for Iohexol

Clinical Trial Phase

Clinical Trial Phase for Iohexol
Clinical Trial Phase Trials
Phase 4 18
Phase 3 9
Phase 2/Phase 3 1
[disabled in preview] 31
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Clinical Trial Status

Clinical Trial Status for Iohexol
Clinical Trial Phase Trials
Completed 34
Recruiting 13
Not yet recruiting 10
[disabled in preview] 9
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Clinical Trial Sponsors for Iohexol

Sponsor Name

Sponsor Name for Iohexol
Sponsor Trials
Eli Lilly and Company 5
National Cancer Institute (NCI) 4
Stanford University 3
[disabled in preview] 12
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Sponsor Type

Sponsor Type for Iohexol
Sponsor Trials
Other 94
Industry 32
NIH 10
[disabled in preview] 2
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Iohexol: Clinical Trials, Market Analysis, and Projections

Introduction to Iohexol

Iohexol, marketed under the brand name OMNIPAQUE™ by GE Healthcare, is a widely used iodinated contrast agent for diagnostic imaging procedures. It is employed in various medical imaging techniques, including angiography, computed tomography (CT) scans, and other radiographic procedures. Here, we will delve into the recent clinical trials, market analysis, and future projections for iohexol.

Clinical Trials Update

Phase 1 Clinical Trial of Captisol-enabled Iohexol

Ligand Pharmaceuticals Incorporated has been at the forefront of developing a Captisol-enabled version of iohexol, aimed at reducing renal toxicity associated with traditional contrast agents. The Phase 1 clinical trial of Captisol-enabled (CE) Iohexol was completed in May 2019, with top-line data released in July 2019[1][3].

Key Findings

  • The trial achieved its primary endpoint by demonstrating pharmacokinetic bioequivalence between CE-Iohexol and the reference agent OMNIPAQUE™.
  • CE-Iohexol was found to be safe and well-tolerated, with adverse events consistent with the known safety profile of OMNIPAQUE™.
  • The study indicated that CE-Iohexol could potentially offer less kidney injury in patients with baseline kidney disease, diabetes, and other associated risk factors[3].

Clinical Significance

The development of CE-Iohexol addresses a significant unmet need in the medical field. Contrast-induced acute kidney injury (CI-AKI) is a common issue, particularly in patients undergoing cardiovascular imaging procedures. With more than 50% of these procedures performed on patients aged 65 or older, the risk of renal injury is heightened. The Captisol-enabled formulation aims to establish a new safety standard for contrast agents, potentially reducing this risk[3].

Market Analysis

Global Iohexol Market Size and Growth

The global iohexol market is substantial and growing. As of 2022, the market size was valued at approximately USD 1.5 billion and is projected to grow at a compound annual growth rate (CAGR) of around 6.9% from 2022 to 2032, reaching USD 2.9 billion by 2032[2].

Market Segmentation

The iohexol market is segmented based on product type (0.99, 0.98, and others) and application (contrast agents, diagnostic agents, and others). The contrast agent segment dominates the market, driven by the increasing need for diagnostic imaging procedures[2].

Iohexol API Market

The global Iohexol Active Pharmaceutical Ingredient (API) market was valued at US$ 506.1 million in 2023 and is anticipated to reach US$ 885.3 million by 2030, with a CAGR of 6.9% during the forecast period 2024-2030. This growth is driven by the increasing demand for precise and high-resolution imaging in the healthcare sector[5].

Market Drivers and Trends

Increasing Demand for Diagnostic Imaging

The growing need for diagnostic imaging methods, particularly in angiography and CT scans, is a key driver of the iohexol market. As the global healthcare sector expands, there is a heightened demand for high-resolution imaging to aid in accurate diagnoses[5].

Technological Advancements

Advancements in medical imaging technologies and the development of safer contrast agents, such as Captisol-enabled iohexol, are expected to further drive market growth. These innovations aim to improve patient safety and the efficacy of diagnostic procedures[3].

Regulatory Environment

The regulatory environment plays a crucial role in the development and approval of new contrast agents. Positive outcomes from clinical trials, such as those seen with CE-Iohexol, can pave the way for regulatory approvals and subsequent market entry[3].

Future Projections

Market Growth Projections

Given the current trends and drivers, the iohexol market is expected to continue its growth trajectory. The projected CAGR of 6.9% from 2022 to 2032 indicates a robust market with significant opportunities for expansion[2].

Potential for Safer Contrast Agents

The development of Captisol-enabled iohexol and similar safer formulations is expected to capture a meaningful market share. These products address the unmet need for reducing renal toxicity, which is a critical concern in the medical community[3].

Commercial Partnerships and Licensing

Ligand Pharmaceuticals is exploring potential commercial partnerships for the CE-Iohexol program. Successful partnerships could accelerate the market penetration of this safer contrast agent, further driving market growth[3].

Key Takeaways

  • Clinical Trials Success: The Phase 1 clinical trial of Captisol-enabled iohexol demonstrated pharmacokinetic bioequivalence and safety, offering a promising alternative to traditional contrast agents.
  • Market Growth: The global iohexol market is projected to grow significantly, driven by increasing demand for diagnostic imaging and technological advancements.
  • Safety and Efficacy: The development of safer contrast agents like CE-Iohexol addresses critical safety concerns, particularly renal toxicity, and is expected to capture a substantial market share.
  • Regulatory and Commercial Opportunities: Positive clinical trial outcomes and potential commercial partnerships are key factors in the future success of iohexol-based products.

FAQs

What is the primary goal of the Captisol-enabled iohexol program?

The primary goal is to develop a next-generation contrast agent with reduced risk of renal toxicity for diagnostic imaging procedures.

How significant is the iohexol market?

The global iohexol market was valued at around USD 1.5 billion in 2022 and is projected to reach USD 2.9 billion by 2032.

What are the main drivers of the iohexol market growth?

The main drivers include the increasing need for diagnostic imaging methods, technological advancements, and the development of safer contrast agents.

What is the significance of the Phase 1 clinical trial results for CE-Iohexol?

The trial demonstrated pharmacokinetic bioequivalence and safety, indicating that CE-Iohexol could potentially reduce kidney injury in at-risk patients.

Are there any regulatory hurdles for new contrast agents like CE-Iohexol?

Yes, regulatory approvals are crucial. Positive clinical trial outcomes can facilitate these approvals and subsequent market entry.

Sources

  1. Ligand Pharmaceuticals Incorporated. "Ligand Completes Enrollment of Phase 1 Clinical Trial of Captisol-enabled Iohexol." May 2, 2019.
  2. KD Market Insights. "Iohexol Market Size, Share, Growth, Trends And Future Outlook 2032."
  3. Ligand Pharmaceuticals Incorporated. "Ligand Announces Positive Top Line Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol." July 10, 2019.
  4. PubMed. "Intravascular studies with iohexol (Omnipaque). Results from the first 49 vascular trials."
  5. Valuates Reports. "Global Iohexol API Market Size, Trends, Growth Analysis, and Forecast."

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