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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR IOPROMIDE


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All Clinical Trials for Iopromide

Trial ID Title Status Sponsor Phase Start Date Summary
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).
NCT00823628 ↗ Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide Completed Seoul National University Bundang Hospital Phase 4 2009-02-01 In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function
NCT00827788 ↗ Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) Completed Ospedale della Misericordia - Grosseto Phase 4 2008-12-01 The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
NCT00827788 ↗ Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) Completed Ospedale Le Scotte Phase 4 2008-12-01 The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
NCT00827788 ↗ Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) Completed Ospedale San Donato Phase 4 2008-12-01 The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Iopromide

Condition Name

Condition Name for Iopromide
Intervention Trials
Contrast Induced Nephropathy 2
Coronary Artery Disease 2
Kidney Failure, Chronic 2
Chronic Renal Insufficiency 1
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Condition MeSH

Condition MeSH for Iopromide
Intervention Trials
Renal Insufficiency 3
Myocardial Ischemia 2
Coronary Disease 2
Coronary Artery Disease 2
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Clinical Trial Locations for Iopromide

Trials by Country

Trials by Country for Iopromide
Location Trials
China 21
Korea, Republic of 3
Italy 2
France 1
Switzerland 1
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Trials by US State

Trials by US State for Iopromide
Location Trials
South Carolina 1
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Clinical Trial Progress for Iopromide

Clinical Trial Phase

Clinical Trial Phase for Iopromide
Clinical Trial Phase Trials
Phase 4 6
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Iopromide
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Iopromide

Sponsor Name

Sponsor Name for Iopromide
Sponsor Trials
Bayer 3
Seoul National University Hospital 2
Ospedale San Donato 1
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Sponsor Type

Sponsor Type for Iopromide
Sponsor Trials
Other 13
Industry 5
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Iopromide: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Iopromide

Iopromide, an iodine-based contrast agent, has recently garnered significant attention with its FDA approval for contrast-enhanced mammography. This article delves into the clinical trials, market analysis, and future projections for iopromide, highlighting its significance in medical imaging and the broader pharmaceutical market.

FDA Approval and Clinical Use

In June 2023, the FDA approved iopromide injection (Ultravist-300, -370) for use in contrast-enhanced mammography, marking it as the first FDA-approved contrast agent for this indication. This approval allows physicians to visualize known or suspected breast lesions in adult patients more effectively, especially when conventional mammography or ultrasound may not suffice[1][4].

Diagnostic Performance

Clinical trials and meta-analyses have demonstrated the efficacy of contrast-enhanced mammography using iopromide. A systematic review and meta-analysis published in the journal Radiology showed a high diagnostic performance, with an overall area under the hierarchical summary receiver operating characteristic curve of 0.94 and a pooled diagnostic odds ratio of 55.7[1].

Adverse Effects and Safety Profile

While iopromide has shown promising diagnostic capabilities, it is not without adverse effects. Common side effects include headache, nausea, injection- and infusion-site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision[4].

Market Analysis

Current Market Size and Growth

The global iopromide API market was valued at US$ 139 million in 2023 and is projected to reach US$ 181.3 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.4% during the forecast period of 2024-2030[2].

Key Players

The iopromide API market is dominated by several key players, including Bayer, Stellite, and Haichang Pharmaceutical. These companies are driving the market through their research and development efforts and strategic partnerships[2].

Market Segments

The market is segmented by type (original drug and generic drug) and application (hospitals and clinics). The demand for iopromide is expected to rise in these segments due to its increasing use in diagnostic imaging procedures[2].

Future Projections

Market Expansion

The approval of iopromide for contrast-enhanced mammography is expected to expand its market reach. As more healthcare professionals adopt this technology, the demand for iopromide is likely to increase, contributing to the market's growth[1][4].

Technological Advancements

Advancements in medical imaging technologies and the integration of contrast agents like iopromide are expected to drive the market forward. The increasing prevalence of breast lesions and the need for accurate diagnostic tools will further fuel the demand for iopromide[1].

Impact on Clinical Trials

Integration in Clinical Trials

The approval of iopromide for contrast-enhanced mammography could influence the design and outcomes of clinical trials focusing on breast cancer and other related conditions. The enhanced diagnostic capabilities provided by iopromide can lead to more accurate and reliable data in these trials[1].

Broader Clinical Trials Market

The global clinical trials market, valued at $48.2 billion in 2023, is projected to reach $73.2 billion by 2028, growing at a CAGR of 8.7%. While iopromide is a specific product, its integration into clinical trials reflects the broader trend of increasing investments in pharmaceutical R&D and the outsourcing of R&D functions to Contract Research Organizations (CROs)[3].

Expert Insights

Konstanze Diefenbach, MD, head of Radiology Research and Development at Bayer, emphasized the significance of iopromide's approval: "The approval of [iopromide] in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough. We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients."[1][4].

Key Takeaways

  • FDA Approval: Iopromide injection is the first FDA-approved contrast agent for contrast-enhanced mammography.
  • Diagnostic Performance: High diagnostic accuracy with an area under the hierarchical summary receiver operating characteristic curve of 0.94.
  • Market Growth: The global iopromide API market is expected to grow at a CAGR of 4.4% from 2024 to 2030.
  • Key Players: Bayer, Stellite, and Haichang Pharmaceutical are major players in the iopromide API market.
  • Future Projections: Increasing demand due to technological advancements and the need for accurate diagnostic tools.

FAQs

What is iopromide used for?

Iopromide is an iodine-based contrast agent used for contrast-enhanced mammography to visualize known or suspected breast lesions in adult patients. It can also be used for other imaging procedures such as excretory urography and contrast computed tomography[4].

Who are the main players in the iopromide API market?

The main players in the iopromide API market include Bayer, Stellite, and Haichang Pharmaceutical[2].

What is the projected growth rate of the iopromide API market?

The iopromide API market is projected to grow at a CAGR of 4.4% from 2024 to 2030[2].

What are the common adverse effects of iopromide?

Common adverse effects include headache, nausea, injection- and infusion-site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision[4].

How does iopromide impact clinical trials?

Iopromide's approval for contrast-enhanced mammography can enhance the accuracy and reliability of data in clinical trials focusing on breast cancer and related conditions, contributing to the broader trend of advancements in clinical trial methodologies[1][3].

Sources

  1. Cancer Network: "Iopromide Injection Receives FDA Approval for Contrast-Enhanced Mammography"
  2. Valuates Reports: "Global Iopromide API Market Research Report 2024"
  3. MarketsandMarkets: "Clinical Trials Market Size, Share, Trends and Revenue Forecast"
  4. OncLive: "FDA Approves Iopromide Injection for Contrast-Enhanced Mammography"

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