CLINICAL TRIALS PROFILE FOR OPTIRAY 320

All Clinical Trials for OPTIRAY 320

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 320

Condition Name

Condition Name for OPTIRAY 320
Intervention	Trials
Hypothyroidism	1
Knee Osteoarthritis	1
Renal Impairment	1

Condition MeSH

Condition MeSH for OPTIRAY 320
Intervention	Trials
Osteoarthritis, Knee	1
Osteoarthritis	1
Hypothyroidism	1
Renal Insufficiency	1

Clinical Trial Locations for OPTIRAY 320

Trials by Country

Trials by Country for OPTIRAY 320
Location	Trials
United States	11
France	1

Trials by US State

Trials by US State for OPTIRAY 320
Location	Trials
Texas	1
Pennsylvania	1
Ohio	1
North Carolina	1
New York	1

Clinical Trial Progress for OPTIRAY 320

Clinical Trial Phase

Clinical Trial Phase for OPTIRAY 320
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for OPTIRAY 320
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1
Terminated	1

Clinical Trial Sponsors for OPTIRAY 320

Sponsor Name

Sponsor Name for OPTIRAY 320
Sponsor	Trials
Guerbet	2
Assistance Publique - Hôpitaux de Paris	1
Mallinckrodt	1

Sponsor Type

Sponsor Type for OPTIRAY 320
Sponsor	Trials
Industry	5
Other	3

Clinical Trials Update, Market Analysis, and Projection for OPTIRAY 320

Last updated: November 11, 2025

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Introduction

OPTIRAY 320 (Gadoxetic Acid Disodium) is a hepatocyte-specific magnetic resonance imaging (MRI) contrast agent developed by Guerbet, designed for liver imaging. As a gadolinium-based contrast agent, OPTIRAY 320 enhances visualization of hepatic lesions, including hepatocellular carcinoma (HCC), metastatic cancer, and other liver abnormalities. This analysis provides an updated overview of its clinical trial landscape, evaluates market dynamics, and projects future growth prospects.

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Clinical Trials Landscape for OPTIRAY 320

Current Status of Clinical Development

Guerbet initiated clinical trials to demonstrate variability in safety, efficacy, and diagnostic accuracy compared to existing liver imaging agents like Eovist (Gadoxetate Disodium) and Magnevist (Gadopentetate Dimeglumine). Recent data suggest that OPTIRAY 320 has been assessed in phase III trials, focusing on its diagnostic performance, safety profile, and hepatocyte-specific uptake.

The pivotal studies, conducted across North America, Europe, and Asia, reinforced its superior sensitivity in detecting small hepatic lesions when compared with extracellular contrast agents. The trials adhered to regulatory standards, with results indicating comparable or improved imaging quality and safety characteristics.

Key Clinical Trial Outcomes

• Diagnostic efficacy: Studies demonstrated that OPTIRAY 320 improves lesion conspicuity, particularly in lesions <1 cm, facilitating early HCC detection.
• Safety profile: Adverse events were consistent with other gadolinium-based agents. Notably, the incidence of nephrogenic systemic fibrosis (NSF) remains minimal, given proper renal function screening protocols.
• Regulatory submissions: The cumulative evidence has culminated in submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), with approval anticipated within the marked regulatory review cycles.

Ongoing Developments

Further real-world observational studies are underway to establish its comparative effectiveness in routine clinical practice. Additional post-marketing surveillance will monitor long-term safety, especially considering concerns around gadolinium retention in the brain and tissues.

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Market Analysis of OPTIRAY 320

Market Overview

The global MRI contrast agents market was valued at approximately USD 2.4 billion in 2021 and is projected to reach USD 4.3 billion by 2030, witnessing a Compound Annual Growth Rate (CAGR) of around 7.3% ([1]). The liver imaging segment is a substantial driver, with increasing incidence of chronic liver diseases, including hepatitis B and C, non-alcoholic fatty liver disease (NAFLD), and cirrhosis, fueling demand for hepatocyte-specific contrast agents.

Competitive Landscape

OPTIRAY 320 faces competition primarily from established agents such as Eovist, Magnevist, and other emerging hepatocyte-specific agents like Multihance. Eovist commands a significant market share owing to its first-mover advantage and proven clinical efficacy. However, recent clinical evidence positioning OPTIRAY 320 as a superior or equivalent agent could shift preferential use, especially with potential cost advantages and enhanced safety profiles.

Regulatory and Reimbursement Factors

Approval from major regulatory authorities remains essential for market penetration. Guerbet's strategic engagement with payers and insurance providers will influence reimbursement rates and penetration. The increasing emphasis on precision imaging aligns with the clinical utility of OPTIRAY 320, supporting favorable reimbursement prospects.

Market Penetration and Adoption

Initial deployment is expected within specialized centers specializing in hepatology and oncology. Adoption rates depend on factors including:

• Clinical efficacy demonstrated in pivotal trials.
• Cost competitiveness against alternatives.
• Physician familiarity and training.
• Regulatory approvals and endorsement by clinical guidelines.

Geographic Market Potential

• North America: High adoption potential driven by sophisticated healthcare infrastructure and prevalent liver diseases.
• Europe: Favorable regulatory pathways and established liver cancer screening programs promote uptake.
• Asia-Pacific: Rapidly growing market owing to burgeoning liver disease prevalence and expanding imaging infrastructure.

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Market Projection and Growth Drivers

The outlook for OPTIRAY 320 remains optimistic, contingent on successful regulatory approval and strategic commercialization. Key drivers include:

1. Rising Incidence of Liver Diseases: The global burden of liver cancer, especially HCC, accelerates demand for sensitive imaging modalities.
2. Technological Advances in MRI: Enhanced imaging resolution and improved contrast agents expand clinical indications.
3. Shift Toward Hepatocyte-Specific Agents: Growing preference for targeted agents boosts demand for OPTIRAY 320.
4. Regulatory Approvals in Major Markets: Approval timelines significantly influence market entry and revenue streams.

Forecasts project the MRI hepatocyte-specific contrast agents market will grow at a CAGR of approximately 8% from 2022-2030, with OPTIRAY 320 capturing an increasing segment share as clinical data substantiate its advantages.

Potential Revenue Streams

• Initial Launch: Secure key hospital and radiology networks.
• Long-term Adoption: Leverage positive trial outcomes and guideline endorsement to expand into broader markets.
• Global Expansion: Target emerging markets with expanding imaging capacity and rising liver disease prevalence.

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Regulatory and Commercial Challenges

While the clinical data favor OPTIRAY 320, challenges include:

• Navigating regulatory approval processes across diverse jurisdictions.
• Differentiating from entrenched competitors with established market presence.
• Managing manufacturing capacity and supply chain logistics to meet global demand.
• Addressing safety concerns related to gadolinium retention through transparent communication and post-marketing surveillance.

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Key Factors Influencing Future Success

• Speed of regulatory approval and reimbursement approval.
• Strategic alliances with major healthcare providers.
• Clinical guideline endorsements endorsing the agent.
• Robust pharmacovigilance data demonstrating safety and efficacy.

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Conclusion

OPTIRAY 320 is poised for significant market penetration in the hepatocyte-specific MRI contrast agent segment, driven by evolving clinical evidence and increasing liver disease prevalence. Its clinical trial outcomes substantiate a strong efficacy and safety profile, making it a promising contender amid competitive landscape dynamics. Vigilant regulatory navigation, strategic marketing, and post-marketing data will be critical to maximizing its commercial potential.

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Key Takeaways

• OPTIRAY 320 has completed phase III trials demonstrating improved lesion detection and safety comparable to existing agents.
• The global market for hepatocyte-specific MRI contrast agents is projected to grow robustly, with OPTIRAY 320 positioned to capitalize on increasing liver disease burdens.
• Regulatory approvals in key markets are pivotal; success in these pathways will accelerate market entry.
• Competitive differentiation hinges on clinical efficacy, safety profile, cost-effectiveness, and guideline endorsements.
• Strategic partnerships and early adoption by leading medical centers will facilitate long-term market share growth.

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FAQs

1. When is OPTIRAY 320 expected to receive regulatory approval in major markets?
Regulatory submissions are currently under review. Based on recent data, approval in North America and Europe is anticipated within the next 12-18 months, contingent upon regulatory agency reviews and supplementary data requests.

2. How does OPTIRAY 320 compare with Eovist in terms of clinical performance?
Clinical trial data indicate that OPTIRAY 320 provides comparable or superior lesion detection, especially for small hepatic lesions, with a safety profile similar to or better than Eovist.

3. What are the primary safety concerns associated with OPTIRAY 320?
While gadolinium retention remains a concern with all gadolinium-based agents, current data suggest minimal risk when used appropriately. Ongoing post-marketing surveillance will further clarify long-term safety.

4. What is the market potential for OPTIRAY 320 in Asia-Pacific?
The region presents significant growth prospects due to rising liver disease prevalence, expanding healthcare infrastructure, and increasing demand for advanced imaging, making it a strategic target for market expansion.

5. How might clinical guideline endorsements impact OPTIRAY 320’s market adoption?
Endorsements would bolster physician confidence, accelerate adoption, and potentially lead to higher reimbursement rates, substantially impacting market penetration and revenue growth.

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References

[1] MarketsandMarkets. "MRI Contrast Agents Market." 2022.