CLINICAL TRIALS PROFILE FOR IOPAMIDOL

All Clinical Trials for IOPAMIDOL

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

Condition Name

Condition Name for IOPAMIDOL
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
HER2-negative Breast Cancer	1

Condition MeSH

Condition MeSH for IOPAMIDOL
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for IOPAMIDOL

Trials by Country

+

−

Trials by Country for IOPAMIDOL
Location	Trials
United States	20
China	2
Canada	2
Italy	2
Sweden	1

Trials by US State

+

−

Trials by US State for IOPAMIDOL
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for IOPAMIDOL

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for IOPAMIDOL

Sponsor Name

Sponsor Name for IOPAMIDOL
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for IOPAMIDOL
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol: Clinical Trials, Market Analysis, and Projections

Introduction to Iopamidol

Iopamidol is a non-ionic, water-soluble iodinated contrast agent widely used in various medical imaging techniques, including computed tomography (CT) scans, angiography, and excretory urography. It enhances the visibility of blood vessels, organs, and other structures within the body, making it an indispensable tool in diagnostic imaging.

Clinical Trials and Safety Profile

Adverse Reactions and Safety

Clinical trials have shown that iopamidol is generally well-tolerated. In a clinical trial involving 76 pediatric patients undergoing angiocardiography, only 2 adverse reactions (2.6%) were remotely attributed to the contrast media[1].

Comparative Studies

A clinical trial comparing iopamidol with iodixanol, another contrast agent, focused on the overall patient comfort profile. The study involved patients undergoing contrast-enhanced computed tomographic imaging of the abdomen/pelvis. While the study aimed to evaluate patient comfort, it also highlighted the safety and efficacy of iopamidol in such procedures[4].

Pharmacokinetics and Distribution

Iopamidol is distributed between the circulating blood volume and other extracellular fluid, with no significant deposition in tissues. It does not cross the blood-brain barrier to any significant extent and displays little tendency to bind to serum or plasma proteins[1].

Market Analysis

Global Market Size and Growth

The global iopamidol injection market is projected to experience significant growth. By 2033, the market is expected to reach a value of several billion dollars, expanding at a CAGR of around 7% during the forecast period from 2025 to 2033. This growth is driven by the increasing prevalence of diagnostic imaging procedures, rising awareness about early disease detection, and technological advancements in radiology[2][5].

Key Drivers

• Increasing Prevalence of Chronic Diseases: Conditions such as cardiovascular and kidney diseases require frequent imaging tests, driving the demand for iopamidol.
• Advancements in Imaging Technologies: The adoption of advanced imaging techniques like CT and MRI is boosting the market.
• Growing Demand for Minimally Invasive Procedures: Iopamidol's use in procedures like angioplasty and coronary angiography is on the rise[2][3][5].

Market Segmentation

The iopamidol injection market is segmented by application, with major segments including:

• Computed Tomography (CT) Scans
• Angiography
• Excretory Urography
• Other Diagnostic Imaging Procedures

Geographically, the market is dominated by North America and Europe, but the Asia-Pacific region is expected to witness the fastest growth due to increasing healthcare expenditure and improving access to healthcare facilities[2][3][5].

Major Market Players

Key players in the iopamidol market include Bracco Imaging, Bayer AG, GE Healthcare, Guerbet Group, and Daiichi Sankyo Company, Limited. These companies are focusing on developing innovative iopamidol-based contrast agents with improved safety profiles and enhanced imaging capabilities. Strategic collaborations and acquisitions are also common strategies to expand product portfolios and gain a competitive edge[2][3][5].

Market Projections

Regional Outlook

• North America: Expected to dominate the market due to the high prevalence of chronic diseases and well-established healthcare infrastructure.
• Europe: Also a significant market due to similar factors.
• Asia-Pacific: Anticipated to witness the fastest growth driven by rising healthcare expenditure and improving access to healthcare facilities[2][3][5].

Future Trends

• Integration of Artificial Intelligence (AI): AI is being integrated into image interpretation to enhance diagnostic precision and procedural efficiency.
• Sustainable Manufacturing Techniques: There is a growing emphasis on developing sustainable manufacturing techniques and innovative delivery methods.
• Low-Osmolality Formulations: Innovations in low-osmolality formulations are making iopamidol safer and more effective[3][5].

Concentration and Characteristics of Iopamidol Injection

Iopamidol injection is available in various concentrations, including 300 mg/mL, 370 mg/mL, and 400 mg/mL. Its characteristics include high water solubility, low osmolality, and a non-ionic nature, making it a safe and effective contrast agent for a variety of imaging procedures[2].

Key Takeaways

• Iopamidol is a widely used non-ionic iodinated contrast agent with a strong safety profile.
• The global iopamidol injection market is projected to grow significantly, driven by increasing diagnostic imaging procedures and technological advancements.
• North America and Europe are current market leaders, but the Asia-Pacific region is expected to grow rapidly.
• Major market players are investing in R&D to innovate and improve product efficacy.
• Future trends include the integration of AI, sustainable manufacturing, and the development of low-osmolality formulations.

FAQs

What is iopamidol used for?

Iopamidol is used as a contrast agent in various medical imaging techniques, including computed tomography (CT) scans, angiography, and excretory urography to enhance the visibility of internal structures.

What are the common concentrations of iopamidol injection?

The common concentrations of iopamidol injection are 300 mg/mL, 370 mg/mL, and 400 mg/mL.

Which regions are expected to dominate the iopamidol market?

North America and Europe are currently dominating the market, but the Asia-Pacific region is expected to witness the fastest growth.

What are the key drivers of the iopamidol market growth?

The key drivers include the increasing prevalence of chronic diseases, advancements in imaging technologies, and the growing demand for minimally invasive procedures.

Are there any significant side effects associated with iopamidol?

Iopamidol is generally well-tolerated, but it can cause transient changes in red cell and leucocyte counts, serum calcium, and other laboratory parameters, though these are not typically associated with clinical manifestations[1].

How does iopamidol distribute in the body?

Iopamidol is distributed between the circulating blood volume and other extracellular fluid, with no significant deposition in tissues and little tendency to bind to serum or plasma proteins[1].