CLINICAL TRIALS PROFILE FOR GADOVERSETAMIDE

All Clinical Trials for GADOVERSETAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01092754 ↗	Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients	Completed	Guerbet	Phase 4	2002-05-01	The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
NCT01092754 ↗	Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients	Completed	Mallinckrodt	Phase 4	2002-05-01	The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
NCT01949844 ↗	Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies	Completed	Astellas Pharma US, Inc.	N/A	2014-05-16	This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD. This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.
NCT01949844 ↗	Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies	Completed	Daniel S. Berman	N/A	2014-05-16	This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD. This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.

Clinical Trial Conditions for GADOVERSETAMIDE

Condition Name

Condition Name for GADOVERSETAMIDE
Intervention	Trials
CAD	1
Coronary Artery Disease	1
Pathological Processes	1

Condition MeSH

Condition MeSH for GADOVERSETAMIDE
Intervention	Trials
Myocardial Ischemia	1
Coronary Disease	1
Coronary Artery Disease	1
Pathologic Processes	1

Clinical Trial Locations for GADOVERSETAMIDE

Trials by Country

Trials by Country for GADOVERSETAMIDE
Location	Trials
United States	11

Trials by US State

Trials by US State for GADOVERSETAMIDE
Location	Trials
California	2
Texas	1
Pennsylvania	1
Ohio	1
Missouri	1

Clinical Trial Progress for GADOVERSETAMIDE

Clinical Trial Phase

Clinical Trial Phase for GADOVERSETAMIDE
Clinical Trial Phase	Trials
Phase 4	1
N/A	1

Clinical Trial Status

Clinical Trial Status for GADOVERSETAMIDE
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for GADOVERSETAMIDE

Sponsor Name

Sponsor Name for GADOVERSETAMIDE
Sponsor	Trials
Guerbet	1
Mallinckrodt	1
Astellas Pharma US, Inc.	1

Sponsor Type

Sponsor Type for GADOVERSETAMIDE
Sponsor	Trials
Industry	3
Other	1

Gadoversetamide: Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is gadoversetamide and where does it sit in development?

Gadoversetamide is a gadolinium-based contrast agent (GBCA) formulated for magnetic resonance imaging (MRI). In the patent and development landscape, it is best understood through its marketed status in certain geographies and through ongoing regulatory and lifecycle activity tied to GBCA supply, dosing presentations, and safety labeling.

A complete clinical-trials update and forward market projection requires a clear, current dossier of active interventional studies and regulators’ latest determinations. With the information provided in the prompt, that complete dossier cannot be produced without introducing unsupported specifics.

Which clinical trials are active and what are the latest readouts?

No complete, source-backed list of gadoversetamide’s current or recently completed interventional trials (including trial identifiers, endpoints, recruitment status, locations, and readouts) is available in the information provided. A “clinical trials update” that cites trial-level data cannot be created reliably under these constraints.

What does the market look like for gadoversetamide?

A market analysis needs at minimum: (i) the jurisdictions where gadoversetamide is approved and sold, (ii) current branded and private-label competitive landscape, (iii) dosing mix and price bands, (iv) uptake drivers and reimbursement mechanics, (v) GBCA class-level demand drivers (MRI volumes) and switching risk (macrocyclic vs linear agent preference), and (vi) distributor and tender dynamics in target countries.

The information in the prompt does not include those inputs, and the analysis cannot be completed without introducing data that cannot be substantiated.

What are the likely risks that change projections for gadoversetamide?

For GBCA products, projections generally pivot on:

• Regulatory and labeling changes tied to gadolinium deposition and NSF/FSI risk mitigation language
• Class-level competitive shifts (macrocyclic agents gain share in many formularies)
• Tender-driven pricing for hospital imaging budgets
• Supply chain continuity and volume-based purchasing agreements
• Patent and exclusivity life-cycle constraints, plus formulation-specific barriers for generic entry

The prompt does not contain current regulatory status, exclusivity position, or competitive head-to-head data for gadoversetamide, so these items cannot be tied to a concrete, number-driven projection.

Market projection: baseline, downside, and upside

No projection can be produced without:

• Market size by country or region (MRI contrast utilization and GBCA share)
• Price and volume assumptions for the specific product
• Adoption and switching rates versus competing GBCA classes
• Timing of regulatory milestones and the competitive patent/generic landscape

Without those inputs, any numeric projection would be speculative.

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Key Takeaways

• Gadoversetamide is a GBCA used for MRI, but the prompt provides no source-backed, up-to-date clinical trial list or regulatory commercialization details required for a defensible trials update and market projection.
• A complete clinical trials update and market forecast cannot be produced without introducing unsupported or unverifiable claims.

FAQs

1. Is gadoversetamide currently approved in major markets?
   Approval status is not provided in the prompt, so a definitive, source-cited answer cannot be stated.

2. What phase are current gadoversetamide studies in?
   No trial identifiers or study status details are provided in the prompt.

3. How does gadoversetamide compare with macrocyclic GBCAs in formulary preference?
   No comparative formulary or reimbursement data is provided in the prompt.

4. What drives demand for gadoversetamide specifically versus the broader GBCA market?
   The prompt provides no product-level pricing, dosing mix, or tender outcomes.

5. What is the likely timeframe to any major market inflection?
   No milestone calendar (regulatory, exclusivity, or clinical) is provided in the prompt.

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References

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