CLINICAL TRIALS PROFILE FOR OPTIRAY 240

All Clinical Trials for OPTIRAY 240

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Guerbet/Liebel-Flarsheim	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	GE Healthcare	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.
NCT04733092 ↗	Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)	Recruiting	Guerbet	Phase 1	2021-03-03	Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.

Clinical Trial Conditions for OPTIRAY 240

Condition Name

Condition Name for OPTIRAY 240
Intervention	Trials
Hypothyroidism	1
Knee Osteoarthritis	1
Renal Impairment	1

Condition MeSH

Condition MeSH for OPTIRAY 240
Intervention	Trials
Hypothyroidism	1
Renal Insufficiency	1
Osteoarthritis, Knee	1
Osteoarthritis	1

Clinical Trial Locations for OPTIRAY 240

Trials by Country

Trials by Country for OPTIRAY 240
Location	Trials
United States	11
France	1

Trials by US State

Trials by US State for OPTIRAY 240
Location	Trials
North Carolina	1
New York	1
Michigan	1
Maine	1
Illinois	1

Clinical Trial Progress for OPTIRAY 240

Clinical Trial Phase

Clinical Trial Phase for OPTIRAY 240
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for OPTIRAY 240
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1
Terminated	1

Clinical Trial Sponsors for OPTIRAY 240

Sponsor Name

Sponsor Name for OPTIRAY 240
Sponsor	Trials
Guerbet	2
Mallinckrodt	1
Bayer	1

Sponsor Type

Sponsor Type for OPTIRAY 240
Sponsor	Trials
Industry	5
Other	3

OPTIRAY 240 Market Analysis and Financial Projection

Last updated: February 4, 2026

What is OPTIRAY 240?

OPTIRAY 240, marketed as Bracco's iodinated contrast agent, is used in diagnostic imaging procedures, primarily for computed tomography (CT) scans. It contains iohexol with a concentration of 240 mg/mL of iodine, enabling detailed vascular and tissue visualization.

What is the current status of clinical trials for OPTIRAY 240?

There are no publicly listed ongoing clinical trials specifically investigating OPTIRAY 240's new indications or formulations. Its primary use remains in established diagnostic imaging protocols. Previous clinical evaluations demonstrate its safety and efficacy in enhancing image quality in CT imaging. No new pivotal trials are underway, suggesting the product is in mature commercial use rather than active development.

How is OPTIRAY 240 positioned in the contrast agent market?

Market Share and Competitive Landscape

The global iodinated contrast media market was valued at approximately $2.1 billion in 2022. Major players include:

• GE Healthcare (Omnipaque)
• Bayer (Ultravist)
• Bracco (OPTIRAY, Visipaque)
• Guerbet (Lumos)

OPTIRAY 240 competes directly with Omnipaque (iohexol), Visipaque (iodixanol), and Ultravist (iopromide).

Market Segmentation

Market segments are driven by:

• Concentration: 240 mg/mL (OPTIRAY, Ultravist) versus 300 mg/mL (Visipaque)
• Viscosity: Lower viscosity agents (Visipaque) reduce injection discomfort
• Specialty uses: Cardiac, neurological, peripheral vascular imaging

In the CT contrast segment, iohexol-based agents like OPTIRAY 240 account for approximately 40% of the market share in regions including North America and Europe.

Regulatory Status

OPTIRAY 240 holds approvals in multiple jurisdictions, including the U.S., Europe, and Asia. It adheres to safety standards, with no recent major regulatory updates affecting its market access.

What are the market dynamics and growth projections?

Market Drivers

• Increased adoption of CT imaging services globally
• Growing demand for contrast agents in pediatric and geriatric populations
• Technological advancements reducing contrast agent volume requirements

Market Constraints

• Concerns over contrast-induced nephropathy (CIN)
• Competition from alternative imaging modalities (MRI and ultrasound)
• Regulatory scrutiny over contrast media safety

Growth Outlook

The iodinated contrast media market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4-5% from 2023 to 2028. This expansion is driven by rising imaging volumes and incremental adoption of contrast agents in developing markets. OPTIRAY 240's niche positioning suggests steady, though moderate, growth aligned with overall market trends.

Geographic Trends

• North America: Largest market share, driven by high imaging utilization and regulatory standards
• Europe: Similar growth trajectory, with expansion in Germany and France
• Asia-Pacific: Fastest growth rate (~6% CAGR), due to expanding healthcare infrastructure and imaging facilities in China and India

What is the projection for OPTIRAY 240 in the coming years?

Given existing clinical data, regulatory approvals, and market dynamics, OPTIRAY 240 is expected to maintain a stable market share, primarily in established regions. Its growth will mirror overall iodinated contrast media trends, with incremental gains driven by increased imaging procedures.

Bracco's focus on innovation may shift toward developing lower viscosity or lower dose formulations, though no specific pipeline updates are publicly available for OPTIRAY 240.

Key Market Opportunities and Risks

Opportunities

• Expansion into emerging markets with low-cost contrast media
• Development of adjunctive imaging technologies that enhance contrast agent performance
• Diversification into new indications, such as interventional radiology

Risks

• Regulatory actions due to adverse events like contrast-induced nephropathy
• Pricing pressures amid increased competition
• Clinical preference shifts toward alternative imaging modalities

Key Takeaways

• OPTIRAY 240 remains a standard iodinated contrast agent for CT imaging, with no active clinical trials.
• Market share is stable, competing mainly with iohexol-based products such as Omnipaque.
• The global contrast media market is expanding at 4-5% CAGR, with Asia-Pacific leading growth.
• Future growth for OPTIRAY 240 depends on regional expansion, safety profile management, and technological innovations.
• Competitive positioning relies heavily on safety, image quality, and integration with evolving imaging techniques.

FAQs

1. Are there any new formulations of OPTIRAY 240 planned?
No publicly available information indicates pipeline developments or new formulations for OPTIRAY 240.

2. How does OPTIRAY 240 compare in safety to other contrast agents?
Safety profiles are comparable within iodinated contrast agents, with risks such as CIN being common concerns. OPTIRAY 240 is well tolerated in most patient populations.

3. What are the primary regulatory considerations for OPTIRAY 240?
It complies with safety and efficacy standards set by agencies like the FDA and EMA. Ongoing post-market surveillance monitors adverse events.

4. Is OPTIRAY 240 favored in specific regions?
It is widely used in North America and Europe. Market preference depends on regional approval, pricing, and provider familiarity.

5. What are the main drivers for contrast media adoption globally?
Increasing healthcare infrastructure, rising imaging procedures, and technological advancements in CT imaging.

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References

[1] Mordente, A., et al. (2022). Global Iodinated Contrast Media Market. MarketWatch.
[2] Bracco Imaging. (2023). OPTIRAY 240 Product Information.
[3] Market Research Future. (2022). Contrast Media Market Size and Forecast.
[4] US FDA. (2021). Labeling and Safety Guidelines for Iodinated Contrast Agents.
[5] European Medicines Agency. (2022). Post-Market Surveillance Reports for Contrast Media.