CLINICAL TRIALS PROFILE FOR IOVERSOL

All Clinical Trials for IOVERSOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Bayer	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Duke Clinical Research Institute	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT02117115 ↗	Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation	Completed	Washington University School of Medicine	Early Phase 1	2014-06-01	Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
NCT02110810 ↗	Indomethacin Decreases Post-ERCP Pancreatitis	Completed	Instituto Mexicano del Seguro Social	Phase 3	2014-01-01	Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.
NCT00793182 ↗	Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography	Terminated	Guerbet	Phase 4	2009-01-01	The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
NCT00793182 ↗	Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography	Terminated	Mallinckrodt	Phase 4	2009-01-01	The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
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 IOVERSOL

Condition Name

Condition Name for IOVERSOL
Intervention	Trials
Renal Impairment	1
Contrast Induced Nephropathy	1
Hypothyroidism	1
Leukemia, Myelogenous, Chronic	1

Condition MeSH

Condition MeSH for IOVERSOL
Intervention	Trials
Preleukemia	1
Graft vs Host Disease	1
Myelodysplastic Syndromes	1
Pancreatitis	1

Clinical Trial Locations for IOVERSOL

Trials by Country

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−

Trials by Country for IOVERSOL
Location	Trials
United States	12
Singapore	1
Mexico	1

Trials by US State

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−

Trials by US State for IOVERSOL
Location	Trials
Arizona	1
Alabama	1
Missouri	1
Texas	1
Pennsylvania	1

Clinical Trial Progress for IOVERSOL

Clinical Trial Phase

Clinical Trial Phase for IOVERSOL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOVERSOL
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for IOVERSOL

Sponsor Name

Sponsor Name for IOVERSOL
Sponsor	Trials
Bayer	1
Duke Clinical Research Institute	1
Guerbet/Liebel-Flarsheim	1

Sponsor Type

Sponsor Type for IOVERSOL
Sponsor	Trials
Other	5
Industry	4

Clinical Trials, Market Analysis, and Projections for Ioversol

Clinical Trials and Safety Profile

Clinical Trials Overview

Ioversol, a nonionic low-osmolality contrast medium, has been extensively evaluated in clinical trials to assess its safety and efficacy. In a significant study involving 1,186 patients, ioversol was administered at iodine concentrations of 32%, 24%, and 16% to evaluate its safety and diagnostic efficacy. The results indicated that ioversol was well tolerated in all patients, showing fewer adverse effects compared to conventional ionic agents[1].

Adverse Effects

While ioversol is generally well tolerated, it is not devoid of adverse effects. Clinical trials involving 4,187 patients revealed that the most common adverse reaction was nausea, occurring at a rate of 1%. Other adverse reactions included cardiac disorders such as cardiac arrest and myocardial infarction, as well as gastrointestinal issues like vomiting and abdominal pain. Serious reactions, though rare, can include convulsions, cerebral hemorrhage, paralysis, renal failure, and cardiac arrest[4].

Renal Function and Other Considerations

Studies have shown that ioversol does not significantly affect renal function, with no clinically or statistically significant changes observed at 24, 48, 72, and 96 hours post-administration[1]. However, it is crucial to administer ioversol under the supervision of experienced professionals to minimize the risk of complications.

Market Analysis

Market Size and Growth

The global ioversol market is projected to grow significantly over the forecast period. By 2026, the market is expected to be valued at $857 million, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2021 to 2026[3].

Key Drivers

Several factors are driving the growth of the ioversol market:

• Increasing Prevalence of Diseases: The rising incidence of cardiovascular disorders, respiratory diseases, and bone-related challenges is driving the demand for diagnostic imaging procedures, thereby boosting the ioversol market[3][5].
• Growing Geriatric Population: The increasing geriatric population, which is more prone to orthopedic and cardiovascular disorders, is another significant driver[2][5].
• Advancements in CT Technology: Improvements in computed tomography (CT) technology are expected to further fuel the market growth[2].

Geographic Segmentation

The ioversol market is segmented geographically, with North America currently holding the largest share due to its advanced healthcare infrastructure and high demand from hospitals. The Asia-Pacific region is anticipated to witness high growth due to increasing pharmaceutical spending and a growing population base, particularly in countries like China and India[2][3].

Market Challenges

Despite the growth potential, the ioversol market faces several challenges:

• Adverse Effects: The potential for severe adverse reactions, such as allergic reactions, cardiac arrest, and renal failure, can restrict market growth[3][4].
• Overdose Risks: Overdose of ioversol can lead to complications like allergic reactions, breathing problems, and dehydration, which also hampers market growth[5].

Market Projections

Future Outlook

The ioversol market is expected to continue its upward trajectory driven by the increasing demand for diagnostic imaging procedures. Here are some key projections:

Increasing Demand for Diagnostic Procedures

The rise in the number of patients suffering from heart diseases, respiratory diseases, and other health conditions will continue to drive the demand for CT scans and X-ray procedures, thereby increasing the demand for ioversol[3].

Impact of COVID-19

The COVID-19 pandemic has accelerated the growth of the ioversol market due to the increased need for diagnostic imaging to detect complications in patients. This trend is expected to continue as healthcare systems recover and adapt to new challenges[3].

Technological Advancements

Advancements in CT technology and other radiological diagnostic examinations are anticipated to provide new opportunities for market growth. These advancements will improve the diagnostic efficacy and patient tolerance of ioversol, further boosting its market[2][5].

Competitive Landscape

Major players in the ioversol market, such as Liebel-Flarsheim Company LLC, Guerbet, Jiangsu Hengrui Medicine Co., and Mallinckrodt Pharmaceuticals, are focusing on product launches, mergers, and acquisitions to expand their market share. These strategies are expected to drive market growth through increased competition and innovation[2][3].

Key Takeaways

• Growing Demand: The ioversol market is driven by the increasing prevalence of cardiovascular and respiratory diseases, as well as the growing geriatric population.
• Safety Profile: Ioversol is generally well tolerated but can have severe adverse effects, emphasizing the need for careful administration.
• Geographic Growth: North America and the Asia-Pacific region are key markets, with the latter expected to show significant growth.
• Technological Advancements: Improvements in CT technology will continue to drive market growth.
• Market Challenges: Adverse effects and overdose risks are significant challenges that need to be addressed.

FAQs

What are the common adverse effects of ioversol?

The most common adverse effect of ioversol is nausea, occurring at a rate of 1%. Other adverse reactions include cardiac disorders, gastrointestinal issues, and in rare cases, convulsions, cerebral hemorrhage, and renal failure[4].

How does ioversol affect renal function?

Ioversol does not significantly affect renal function, with no clinically or statistically significant changes observed at 24, 48, 72, and 96 hours post-administration[1].

What are the key drivers of the ioversol market?

The key drivers include the increasing prevalence of cardiovascular and respiratory diseases, the growing geriatric population, and advancements in CT technology[2][3][5].

Which regions are expected to show significant growth in the ioversol market?

North America currently holds the largest share, but the Asia-Pacific region is expected to witness high growth due to increasing pharmaceutical spending and a growing population base[2][3].

What are the potential challenges facing the ioversol market?

The potential for severe adverse reactions and overdose risks are significant challenges that could restrict market growth[3][4][5].

Sources

1. Ioversol clinical safety summary - PubMed
2. Ioversol Market - Companies, Size, Share & Research Analysis - Coherent Market Insights
3. Ioversol Market Share, Size and Industry Growth Analysis 2019 - 2024 - IndustryARC
4. OPTIRAY® (ioversol) injection, for intra-arterial or intra-venous use - FDA
5. Global Ioversol Market - Allied Market Research