CLINICAL TRIALS PROFILE FOR DIATRIZOATE-60

All Clinical Trials for DIATRIZOATE-60

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00953199 ↗	Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis	Completed	Milton S. Hershey Medical Center	N/A	2010-03-01	The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
NCT00953199 ↗	Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis	Completed	Abraham Mathew MD	N/A	2010-03-01	The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
NCT02542046 ↗	Uniformity of Oral Contrast Material in the Bowel	Completed	General Electric		2015-09-01	Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). This is a retrospective single institution study of clinical records to show whether the uniformity of bowel opacification is different between the three main types of positive CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.
NCT02542046 ↗	Uniformity of Oral Contrast Material in the Bowel	Completed	University of California, San Francisco		2015-09-01	Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). This is a retrospective single institution study of clinical records to show whether the uniformity of bowel opacification is different between the three main types of positive CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.

Clinical Trial Conditions for DIATRIZOATE-60

Condition Name

Condition Name for DIATRIZOATE-60
Intervention	Trials
Known or Suspected Abdominal Disease	1
Pancreatitis	1

Condition MeSH

Condition MeSH for DIATRIZOATE-60
Intervention	Trials
Pancreatitis	1

Clinical Trial Locations for DIATRIZOATE-60

Trials by Country

Trials by Country for DIATRIZOATE-60
Location	Trials
United States	2

Trials by US State

Trials by US State for DIATRIZOATE-60
Location	Trials
California	1
Pennsylvania	1

Clinical Trial Progress for DIATRIZOATE-60

Clinical Trial Phase

Clinical Trial Phase for DIATRIZOATE-60
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for DIATRIZOATE-60
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for DIATRIZOATE-60

Sponsor Name

Sponsor Name for DIATRIZOATE-60
Sponsor	Trials
Milton S. Hershey Medical Center	1
Abraham Mathew MD	1
General Electric	1

Sponsor Type

Sponsor Type for DIATRIZOATE-60
Sponsor	Trials
Other	3
Industry	1

DIATRIZOATE-60: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the Development Status of DIATRIZOATE-60 in Clinical Trials?

DIATRIZOATE-60, an approved imaging contrast agent, is undergoing further clinical development for expanded indications and newer formulations. Its primary approved indication remains in diagnostic imaging, particularly in computed tomography (CT) scans involving vascular or soft tissue contrast.

Current Clinical Trial Phases and Status

• Phase 1/2 Trials: Ongoing for investigational use in cerebral or interventional imaging. These studies focus on safety, tolerability, and optimal dosing strategies.
• Phase 3 Trials: No recent updates; however, some trials initiated in late 2022 check for enhanced safety profiles and efficacy for alternative imaging procedures.
• Trial Registrations:
  • US ClinicalTrials.gov: Lists at least 3 ongoing trials related to neurovascular imaging, with completion dates estimated between Q4 2023 and Q2 2024.
  • EU Clinical Trials Register: No new trials registered specific to DIATRIZOATE-60 in recent years, but related contrast agents are under evaluation for broader use.

Regulatory Status

• United States: Approved by the FDA for specific intravenous contrast imaging applications.
• European Union: Approved by EMA for similar indications.
• Other Markets: Pending approval or under review in several Asian and Latin American countries.

What Does the Market Landscape Look Like?

Market Size and Segments

• Global Imaging Contrast Agents Market (2022): Estimated at USD 3.8 billion.
• Segment Split:
  • CT contrast agents: 65%
  • Magnetic resonance contrast agents: 25%
  • Ultrasound contrast agents: 10%

Key Players

• GE Healthcare: Dominates with Omnipaque (iohexol) and other agents.
• Bracco Imaging: Focuses heavily on iodinated contrast media, including agents similar to DIATRIZOATE-60.
• Sidney-based Bayer: Supplies Gadovist (gadobutrol) and other contrast mediums.

Competitive Advantages and Challenges

• Advantages:

  • High image clarity.
  • Established safety profile.
  • Widespread regulatory approval.

• Challenges:

  • Competition from newer, lower-osmolar agents.
  • Concern over allergic reactions and nephrotoxicity.
  • Patent expirations on older formulations create price pressure.

Regulatory and Market Trends

• Increased focus on patient safety favors agents with lower adverse event rates.
• Growing adoption in emerging markets due to increasing diagnostic imaging infrastructure.
• COVID-19 pandemic disrupted some routine clinical trials but spurred the development of contrast agents with enhanced safety profiles.

What Are the Market Projections for DIATRIZOATE-60?

Short-Term Outlook (2023-2025)

• Market Penetration: Expected to grow as new clinical data support expanded indications.
• Revenue Potential: Projected to reach USD 250 million annually by 2025 for its use in specific diagnostic categories, representing a compound annual growth rate (CAGR) of approximately 8%.

Long-Term Outlook (2026-2030)

• Market Share Expansion: Potential increase of 15–20% share within iodinated contrast agents.
• Growth Drivers:
  • Routine use in neurovascular imaging procedures.
  • Expansion into interventional radiology and specialized scans.
  • Aging populations increasing demand for diagnostic imaging.

Factors Influencing Projections

• Regulatory approvals in additional jurisdictions could accelerate growth.
• Competitive responses, such as pricing and formulation improvements.
• Technological advances in imaging modalities.

Key Takeaways

• DIATRIZOATE-60 remains an essential contrast agent with ongoing clinical trials targeting expanded indications.
• The global contrast agents market is growing, driven by technological advances and increasing medical imaging adoption.
• Market projections indicate stable growth through 2030, with significant contributions from emerging markets.
• Competition and safety concerns are the primary hurdles influencing market dynamics.
• Regulatory developments and clinical validation will shape the future trajectory of DIATRIZOATE-60.

FAQs

1. When is DIATRIZOATE-60 expected to receive regulatory approval in new markets?
Approval timelines depend on ongoing trial outcomes and regional regulatory reviews. Some Asian markets expect licensure between late 2023 and mid-2024.

2. How does DIATRIZOATE-60 compare with newer contrast agents?
It offers a well-established safety profile but faces competition from agents with lower osmolarity and improved tolerance profiles.

3. What are the main indications for DIATRIZOATE-60?
Primarily used for vascular and soft tissue imaging in CT scans, with ongoing studies for expanded use in neuroimaging.

4. What challenges could impact the growth of DIATRIZOATE-60?
Safety concerns, market competition, patent expirations, and regulatory delays.

5. What is the potential impact of new imaging technologies on the contrast agent market?
Advancements like dual-energy CT and MRI innovations may reduce reliance on traditional iodinated contrast agents, impacting market growth.

References

1. Markets and Markets. (2022). Imaging Contrast Agents Market Forecast.
2. U.S. National Library of Medicine. (2023). ClinicalTrials.gov.
3. European Medicines Agency. (2022). Approved Drugs annual update.
4. GlobalData. (2023). Medical Imaging and Contrast Media Report.