CLINICAL TRIALS PROFILE FOR MANGAFODIPIR TRISODIUM

All Clinical Trials for mangafodipir trisodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01326715 ↗	Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2013-10-17	Background: - Contrast agents are drugs that make certain body areas or abnormalities show up better on imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI contrast agent with manganese that has been approved for MRI scans of the liver and pancreas. Because contrast agents with manganese have also been shown to be useful in studying problems with the nervous system, researchers are interested in determining if mangafodipir may be used for MRI scans of the brain or eye, two areas that often experience problems caused by disorders that affect the nervous system, such as multiple sclerosis. However, more information is needed on whether mangafodipir will be useful for this purpose, or how best to use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are interested in studying its use in both individuals with multiple sclerosis and healthy volunteers. Background: - Contrast agents are drugs that make certain body areas or abnormalities show up better on imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI contrast agent with manganese that has been approved for MRI scans of the liver and pancreas. Because contrast agents with manganese have also been shown to be useful in studying problems with the nervous system, researchers are interested in determining if mangafodipir may be used for MRI scans of the brain or eye, two areas that often experience problems caused by disorders that affect the nervous system, such as multiple sclerosis. However, more information is needed on whether mangafodipir will be useful for this purpose, or how best to use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are interested in studying its use in both individuals with multiple sclerosis and healthy volunteers. Objectives: - To evaluate the safety and effectiveness of mangafodipir in imaging studies of nerve disorders affecting the eye and brain. Eligibility: - Individuals between 18 and 70 years of age who either have been diagnosed with multiple sclerosis or are healthy volunteers. Design: - Participants will be screened with a physical examination, medical history, and blood tests. - Participants will have up to 10 outpatient visits for screening and MRI scans over a period of up to 2 months. Participants will be divided into Eye and Brain groups, based on which area will be studied during the scans. (Participants who have available time may be eligible for study in both groups.) - Participants will have an initial MRI scan as part of the screening process. - At the first visit, participants will have a baseline MRI scan once before receiving mangafodipir. - Participants will have up to five MRI scans, with the following procedures: - Eye imaging group: MRI scans will be scheduled at specific times between 2 and 48 hours after receiving mangafodipir. Eye MRI participants will wear a dark contact lens and an eye patch for 30 minutes before receiving mangafodipir, and leave both on for up to 8 hours. The other eye will remain uncovered. - Brain imaging group: MRI scans will be scheduled at specific times between 48 hours and 7 days after receiving mangafodipir. - Participants will have a follow-up MRI scan 1 month after receiving mangafodipir. This scan is done to see how long mangafodipir may affect MRI images of the brain.
NCT06731738 ↗	Mangafodipir - an Intracellular Contrast Agent for Magnetic Resonance Imaging (MRI): Measuring Manganese Uptake Rate in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) Patients.	RECRUITING	IC TARGETS AS	PHASE2	2024-11-22	More than half of heart failure patients have preserved ejection fraction (HFpEF), a condition caused by increased wall stiffness that impairs proper heart filling. Two types of cardiac fibrosis, replacement fibrosis and interstitial fibrosis, contribute to this stiffening. In addition, altered calcium handling in the cardiomyocytes is relevant. The currently available contrast agents in Magnetic Resonace Imaging (MRI) primarily detect cell loss caused by replacement fibrosis, and measurements of the extracellular volume provide clues about the status of interstitial fibrosis. However, the planned trial aims to utilise mangafodipir trisodium to measure cellular function independent of the impact of fibrosis. This information could be vital for accurate diagnosis, selection and monitoring of therapy. In addition, manganese-enhanced magnetic resonance imaging (MEMRI) may be used as an alternative to examinations with gadolinium-based contrast agents in the future.

Clinical Trial Conditions for mangafodipir trisodium

Condition Name

Condition Name for mangafodipir trisodium
Intervention	Trials
Heart Failure With Preserved Ejection Fraction (HFPEF)	1
Multiple Sclerosis	1
Optic Neuritis	1

Condition MeSH

Condition MeSH for mangafodipir trisodium
Intervention	Trials
Neuritis	1
Multiple Sclerosis	1
Heart Failure	1
Heart Diseases	1

Clinical Trial Locations for mangafodipir trisodium

Trials by Country

Trials by Country for mangafodipir trisodium
Location	Trials
United States	1
Norway	1

Trials by US State

Trials by US State for mangafodipir trisodium
Location	Trials
Maryland	1

Clinical Trial Progress for mangafodipir trisodium

Clinical Trial Phase

Clinical Trial Phase for mangafodipir trisodium
Clinical Trial Phase	Trials
PHASE2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for mangafodipir trisodium
Clinical Trial Phase	Trials
RECRUITING	1
Completed	1

Clinical Trial Sponsors for mangafodipir trisodium

Sponsor Name

Sponsor Name for mangafodipir trisodium
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	1
IC TARGETS AS	1

Sponsor Type

Sponsor Type for mangafodipir trisodium
Sponsor	Trials
NIH	1
OTHER	1

Mangafodipir trisodium: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is mangafodipir trisodium and what is it used for?

Mangafodipir trisodium is a gadolinium-free MRI contrast agent approved for imaging of liver lesions with hepatocyte-specific uptake and subsequent biliary excretion. In market-facing terms, it targets abdominal MRI workflows where liver lesion characterization matters.

Core product identifiers

• Active ingredient: mangafodipir trisodium
• Drug class: hepatobiliary MRI contrast agent
• Common brand: Teslascan (widely used reference brand; regional branding varies)

What is the current clinical development status?

No new, material late-stage (Phase 3) development programs were identified for mangafodipir trisodium in major public trial registries at the level needed to support a complete, decision-grade “clinical trials update” and forward-looking projection.

Clinical trial activity observable in public sources

• Mangafodipir trisodium has a mature approval history and has largely shifted from development-stage activity to post-marketing evidence and incremental label or practice documentation.
• Public trial records typically show older studies and observational follow-ups rather than ongoing Phase 2/3 programs that would change competitive positioning or regulatory timelines.

Practical interpretation for R&D and investment

• Near-term clinical momentum is not driven by new Phase 3 readouts.
• Any “clinical update” that meaningfully impacts market share would likely come from: (1) comparative effectiveness evidence in current MRI standards, (2) guideline inclusion in liver imaging pathways, or (3) supply and access dynamics rather than new trial outcomes.

What approvals and regulatory milestones matter for commercialization?

Mangafodipir trisodium’s commercialization is shaped by historical approval in key jurisdictions and by safety and supply considerations typical for contrast agents, including exposure-dependent labeling and contraindication management.

Regulatory framing

• It is positioned for MRI liver imaging workflows, not as a universal contrast replacement for extracellular agents.
• Adoption depends on radiology department purchasing, protocol preferences, and reimbursement structure by region.

What does the market look like and who competes?

The global MRI contrast market is dominated by gadolinium-based extracellular and hepatobiliary agents. Mangafodipir trisodium competes in the hepatobiliary segment, where usage is defined by imaging protocol fit, safety perceptions, and price.

Competitive set (hepatobiliary MRI contrast agents)

• Gadoxetate disodium (Primovist/Eovist, gadoxetic acid): hepatocyte uptake agent with strong presence in many markets.
• Other regional hepatobiliary options: availability varies by country and regulatory status.
• Non-hepatocyte gadolinium extracellular agents: compete indirectly through broader “default” use in abdominal MRI.

Competitive dynamics that influence shares

• Radiology protocols increasingly standardize around high-evidence hepatobiliary agents (where payers and clinical societies align).
• Department contracts often favor fewer SKUs for procurement simplicity.
• Safety messaging around gadolinium retention and contrast deposition influences radiologist choice and patient selection logic even for agents with different chemistry.

How does mangafodipir trisodium perform in adoption terms?

Mangafodipir trisodium’s adoption is best described as protocol- and guideline-dependent rather than universal. In liver imaging, the decision is often between:

• hepatobiliary uptake agents (protocol-specific lesion timing windows)
• and extracellular gadolinium agents (broader MRI coverage with fewer protocol constraints)

Where hepatobiliary workflows are entrenched and reimbursement supports it, mangafodipir trisodium benefits. Where protocols shift to other hepatobiliary brands (particularly gadoxetate-based options), share erosion is plausible.

What is the demand driver and what limits growth?

Demand drivers

• Need for high-quality liver lesion characterization in MRI pathways.
• Institutional preference for hepatobiliary timing protocols.

Growth limiters

• Strong competitor presence in hepatobiliary MRI.
• Contracting and formulary dynamics that consolidate contrast-agent purchasing.
• Mature product lifecycle without new trial milestones that reset physician or payer behavior.

Market analysis: sizing approach and projection logic

A decision-grade forecast requires anchored baseline units or revenue, plus region-specific usage and payer/reimbursement trends. In the absence of extractable, citable baseline sales volume or region-level revenue for mangafodipir trisodium specifically, a complete numeric projection cannot be produced to the standard requested.

Accordingly, the only projection that can be stated without fabricating fundamentals is qualitative and tied to market structure:

Projection (directional)

• Base case: flat-to-low-growth in volume, with share challenged by competing hepatobiliary agents in many markets.
• Downside: continued substitution toward other hepatobiliary brands, coupled with ongoing tender consolidation.
• Upside: localized formulary wins, imaging guideline endorsements in specific liver imaging protocols, or supply stabilization enabling stronger tender performance.

This directional outlook is consistent with how mature contrast agents behave: growth tracks MRI exam volumes and formulary decisions more than incremental innovation.

What is the risk map for investors and R&D planners?

Competitive and clinical risks

• Substitution risk to other hepatobiliary agents with stronger market penetration.
• Limited clinical “reset” events because the product does not show a clear current pipeline of late-stage trials that could re-accelerate uptake.

Regulatory and access risks

• Labeling and safety scrutiny typical for contrast products, which can constrain patient subsets.
• Tender and supply chain continuity, which can swing short-term utilization.

Commercial execution risks

• Radiology department contracting favors pricing and protocol simplicity.
• Payer policies can steer selection toward preferred brands.

Key dates and lifecycle markers that influence near-term outcomes

• Mangafodipir trisodium is a mature product; major near-term catalysts would typically be:
  • Phase 3 readouts (not evident in public late-stage activity at decision-grade level)
  • Label expansion (not evidenced here at decision-grade level)
  • Country-specific access changes tied to tenders and reimbursement

Because no decision-grade late-stage readouts are available for this request, the forecast horizon is governed mainly by MRI volume growth and competitive substitution.

What should a decision-maker track over the next 12 to 24 months?

1. Tender outcomes and formulary placement in high-MRI-volume regions for hepatobiliary contrast products.
2. Protocol preference shifts in liver lesion imaging (timing windows, agent selection rules).
3. Supply continuity (stock-outs reduce recurring contract utilization).
4. Guideline mentions that explicitly recommend or compare hepatobiliary agents in liver MRI algorithms.

Key Takeaways

• Mangafodipir trisodium is a mature hepatobiliary MRI contrast agent used for liver lesion imaging and is shaped more by formulary and protocol selection than by new clinical innovation.
• A decision-grade “clinical trials update” with late-stage catalysts cannot be supported here because no current, material Phase 3 development signals are available at the needed evidence level.
• Market trajectory is best read as MRI exam volume plus hepatobiliary brand substitution risk versus competitor agents with strong penetration.
• Near-term commercial performance is most sensitive to tender placement, protocol adoption in liver imaging, and supply continuity.

FAQs

Is mangafodipir trisodium in active Phase 3 clinical development?

No decision-grade Phase 3 program is evident from public sources sufficient to support a catalyst-based update.

What is the main competitive threat to mangafodipir trisodium?

Substitution toward other hepatobiliary MRI contrast agents, particularly gadoxetate-based products, driven by formulary preference and protocol fit.

What drives usage in real-world liver MRI?

Institutional liver MRI protocols, radiologist timing practices, and procurement contracting for contrast-agent brands.

What are the biggest non-clinical risks?

Tender and supply continuity risk, plus reimbursement and formulary consolidation that reduces brand diversity.

What type of evidence would most change market share?

Comparative effectiveness evidence aligned to current liver MRI pathways, plus guideline or payer alignment that explicitly changes hepatobiliary agent selection rules.

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References

[1] ClinicalTrials.gov. “Clinical Trials” database. https://clinicaltrials.gov/
[2] European Medicines Agency (EMA). “Public Assessment Reports and medicine information for MRI contrast agents.” https://www.ema.europa.eu/
[3] U.S. Food and Drug Administration (FDA). “Drugs@FDA” and label database for MRI contrast agents. https://www.accessdata.fda.gov/scripts/cder/daf/