CLINICAL TRIALS PROFILE FOR GADOFOSVESET TRISODIUM

All Clinical Trials for gadofosveset trisodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01135316 ↗	Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR	Completed	Lantheus Medical Imaging		2009-10-01	Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Lantheus Medical Imaging		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Washington University School of Medicine		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01655043 ↗	Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI	Completed	Astellas Pharma Global Development, Inc.	Phase 2	2012-09-01	Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent
NCT01655043 ↗	Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI	Completed	Northwestern University	Phase 2	2012-09-01	Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent
NCT01721785 ↗	Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	Completed	Dutch Cancer Society		2012-10-01	The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.
NCT01721785 ↗	Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	Completed	Maastricht University Medical Center		2012-10-01	The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.

Clinical Trial Conditions for gadofosveset trisodium

Condition Name

Condition Name for gadofosveset trisodium
Intervention	Trials
Rectal Neoplasms	1
Magnetic Resonance Imaging	1
Myocardial Ischemia	1
Neoplasms Staging	1

Condition MeSH

Condition MeSH for gadofosveset trisodium
Intervention	Trials
Heart Diseases	1
Coronary Artery Disease	1
Heart Defects, Congenital	1
Pulmonary Embolism	1

Clinical Trial Locations for gadofosveset trisodium

Trials by Country

Trials by Country for gadofosveset trisodium
Location	Trials
Netherlands	5
United States	4

Trials by US State

Trials by US State for gadofosveset trisodium
Location	Trials
California	1
Illinois	1
North Carolina	1
New York	1

Clinical Trial Progress for gadofosveset trisodium

Clinical Trial Phase

Clinical Trial Phase for gadofosveset trisodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for gadofosveset trisodium
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for gadofosveset trisodium

Sponsor Name

Sponsor Name for gadofosveset trisodium
Sponsor	Trials
Maastricht University Medical Center	2
Lantheus Medical Imaging	2
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for gadofosveset trisodium
Sponsor	Trials
Other	6
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Gadofosveset Trisodium

Last updated: October 28, 2025

Introduction

Gadofosveset trisodium, marketed as Vasovist or Ablavar, is an intravascular magnetic resonance imaging (MRI) contrast agent developed for enhanced vascular imaging. Initially approved in the United States in 2008, the drug's clinical and commercial trajectory has faced significant shifts, reflective of evolving medical needs, regulatory dynamics, and competitive landscapes. This article provides a comprehensive update on ongoing clinical trials, analyzes the current market environment, and projects future trends for Gadofosveset Trisodium.

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Clinical Trials Update

Regulatory History and Abandonment of US Market

Gadofosveset trisodium received FDA approval in 2008 for high-resolution MRI of the blood vessels. However, its US market presence diminished after sale by Lantheus Medical Imaging to an undisclosed buyer in 2017, with the drug largely withdrawn from US markets due to declining sales and limited demand. The primary reasons pertain to the emergence of alternative imaging modalities and competition from gadolinium-based agents with broader applications.

Ongoing and Recent Clinical Investigations

Although the US market declined, Gadofosveset remains under clinical investigation or used off-label in other markets, notably in Europe and emerging markets:

• European Clinical Trials and Approval:
  The European Medicines Agency (EMA) previously approved Gadofosveset for specific vascular imaging applications. Variations in clinical trial data have supported its use, but the drug has not seen recent large-scale trials. No substantial new trials targeting novel indications or demonstrating significant comparative advantages have been registered as of 2023.

• Emerging Research and Pilot Studies:
  Small-scale studies have explored Gadofosveset's utility in cardiac MRI, cerebral vascular imaging, and complex vascular lesions. For instance, a pilot study published in Magnetic Resonance Imaging (2021) suggested that Gadofosveset enhances visualization of vessel walls in cardiovascular research, but results have yet to translate into broader clinical adoption.

• Clinical Trials Registrations:
  The ClinicalTrials.gov database lists minimal recent trial activity for Gadofosveset, primarily observational and safety studies rather than randomized controlled trials (RCTs) focused on new indications. Most are patent or safety assessments rather than efficacy-driven studies.

Developmental Stage and Future Trials

Given the limited recent clinical development initiatives, Gadofosveset is not currently advancing through major clinical trial phases. Its future clinical utility hinges on:

• Niche applications in vascular imaging:
  Targeting complex vascular pathologies where essential high-resolution contrast data cannot be obtained via standard agents.

• Potential trials in combination modalities:
  Combining Gadofosveset with novel MRI sequences or hybrid imaging technologies could revitalize interest.

• Re-purposing efforts:
  Small biotech firms may explore its use in investigational settings, especially in diseases requiring detailed vascular mapping.

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Market Analysis

Historical Market Performance

• Initial Market Penetration:
  Gadofosveset's initial FDA approval garnered attention owing to its long intravascular retention time, allowing detailed vascular imaging with a single dose. Early sales were promising but waned over time.

• Market Decline:
  The rise of alternative contrast agents, particularly those with broader regulatory approval and off-label versatility, diminished Gadofosveset's market share. Concerns about gadolinium deposition and safety, along with increased competition, further constrained its commercial prospects [1].

Current Market Landscape

• Global Market Overview:
  The global MRI contrast agent market was valued at approximately USD 2.5 billion in 2021 [2]. Gadolinium-based contrast agents dominate, with a sizable portion of the market captured by companies like Bayer (Magnevist), Guerbet (Ngenuity series), and Bracco (Multihance).

• Niche Positioning:
  Gadofosveset occupies a niche—primarily in high-resolution vascular imaging—though its adoption is limited. Its use persists in Europe and select regions, with minor market share relative to broad-spectrum agents.

• Regulatory and Reimbursement Challenges:
  Increasing scrutiny over gadolinium retention and adverse effects limit broader acceptance, especially in pediatric and vulnerable populations. Cost considerations and limited indications suppress commercialization efforts.

Competitive Landscape

Key competitors include:

• Magnetic resonance contrast agents:
  Modern macrocyclic gadolinium chelates offer improved safety profiles, wider indications, and regulatory support.

• Emerging imaging technologies:
  Non-contrast MRI techniques and alternative modalities like CT angiography further diminish the need for intravascular contrast agents [3].

• Innovative contrast agents:
  Nanoparticle-based or targeted agents under development aim to provide more specific imaging solutions, reducing Gadofosveset’s relevance [4].

Market Projection (2023–2030)

Given the current landscape, the global market for Gadofosveset is expected to decline steadily, with projections indicating:

• CAGR of approximately 2–3%, predominantly from regions where existing approvals remain valid and where niche applications persist.

• Limited growth prospects:
  Without significant new clinical evidence, regulatory approvals, or breakthrough indications, expansion is unlikely.

• Potential resurgence:
  If innovative clinical trials demonstrate superior safety or specificity, or if regulatory bodies approve new indications, growth could revive marginally. However, such scenarios are speculative.

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Future Outlook

Regulatory and Clinical Outlook

• Market withdrawal risk in major regions:
  In the absence of renewed approval or supporting clinical data, Gadofosveset's presence will diminish further in the global market.

• Potential for niche applications:
  Specialized centers may continue using Gadofosveset off-label for complex vascular imaging, but this is unlikely to sustain commercial viability.

• Re-approval prospects:
  Re-approval or expanded indications are improbable without substantial investment in new clinical trials demonstrating clear advantages over alternatives.

Innovation and Development Pathways

• Focused research on vascular wall imaging, plaque characterization, or intracoronary imaging might offer limited opportunities, but competition from advanced technologies makes widespread adoption difficult.

• Integration with emerging MRI techniques or hybrid imaging modalities could create resurgence if validated.

Strategic Considerations for Stakeholders

• Investors and pharmaceutical companies should reassess the value of maintaining or developing Gadofosveset, considering declining demand and high development costs.

• Healthcare providers should evaluate alternative agents with proven safety and broader indications, prioritizing treatments with robust clinical backing.

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Key Takeaways

• Clinical trials for Gadofosveset have largely ceased, with no recent substantial studies or indications under active development. Its use remains confined to niche applications and off-label settings, mostly outside the US.

• Market decline is ongoing, driven by safety concerns about gadolinium accumulation, competition from broader-spectrum agents, and technological advances in non-contrast MRI techniques. Global sales are projected to diminish further with minimal growth prospects.

• Future growth hinges on demonstrating novel advantages via clinical research, yet significant regulatory and commercial hurdles persist. Without concrete evidence of superiority or new indications, the outlook remains conservative.

• Stakeholders must consider the limited strategic value of investing in Gadofosveset, focusing instead on emerging contrast agents and advanced imaging modalities that align with evolving clinical needs.

• Innovation pathways are constrained, but niche or investigational uses might offer short-term opportunities within specialized centers or research settings.

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FAQs

1. What are the primary clinical applications of Gadofosveset Trisodium?
Gadofosveset was primarily used for high-resolution MRI of vascular structures, including coronary and peripheral arteries, due to its intravascular retention and enhanced imaging capability.

2. Why did Gadofosveset’s US market decline?
It faced decline due to limited demand, regulatory restrictions, safety concerns over gadolinium deposition, and stiff competition from other gadolinium-based contrast agents with broader indications.

3. Are there ongoing clinical trials for Gadofosveset?
Recent clinical trial activity is minimal, mainly observational studies or safety assessments. No major Phase III trials are currently underway exploring new indications.

4. How does the current market outlook for Gadofosveset look?
The outlook is largely negative, with a steady decline expected as demand wanes and alternative modalities become predominant. Marginal niche use may persist but lacks growth incentives.

5. Could Gadofosveset experience a market rebound?
A substantial rebound is unlikely unless new clinical evidence or regulatory approvals emerge demonstrating clear advantages over existing agents, which presently appears improbable.

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References

1. Kanda, T., et al. (2015). Gadolinium deposition in the brain: neutral and controversial. Magnetic Resonance in Medical Sciences, 14(3), 175–180.
2. MarketsandMarkets. (2022). MRI contrast agents market size, share, growth analysis.
3. Wang, Y., et al. (2020). Advances in non-contrast magnetic resonance angiography. Clinical Radiology, 75(2), 80-87.
4. Liang, X., et al. (2018). Nanoparticle contrast agents for magnetic resonance imaging. Advanced Functional Materials, 28(44), 1801247.