CLINICAL TRIALS PROFILE FOR GADOXETATE DISODIUM

« Back to Dashboard

All Clinical Trials for GADOXETATE DISODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01867424 ↗	Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2013-05-14	Background: - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well. Objectives: - To see if gadoxetate can help identify different types of prostate cancers during imaging studies. Eligibility: - Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. - Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan. - Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study. - Treatment will not be provided as part of this study.
NCT02156739 ↗	Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	Recruiting	National Cancer Institute (NCI)	N/A	2014-10-13	This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
NCT02156739 ↗	Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	Recruiting	M.D. Anderson Cancer Center	N/A	2014-10-13	This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
NCT02226666 ↗	Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration	Completed	University of Michigan		2013-08-01	The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).
NCT02431598 ↗	Eovist vs. Dotarem Healthy Volunteer MRI	Completed	University of California, San Diego	Phase 4	2015-06-01	The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
NCT02431598 ↗	Eovist vs. Dotarem Healthy Volunteer MRI	Completed	University of Wisconsin, Madison	Phase 4	2015-06-01	The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
NCT02431598 ↗	Eovist vs. Dotarem Healthy Volunteer MRI	Completed	Duke University	Phase 4	2015-06-01	The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.

Clinical Trial Conditions for GADOXETATE DISODIUM

Condition Name

Condition Name for GADOXETATE DISODIUM
Intervention	Trials
Metastatic Malignant Neoplasm in the Liver	1
Contrast Media	1
Motor Function	1
Hepatic Disease	1

Condition MeSH

Condition MeSH for GADOXETATE DISODIUM
Intervention	Trials
Liver Neoplasms	4
Liver Diseases	2
Carcinoma, Hepatocellular	2
Bile Duct Diseases	1

Clinical Trial Locations for GADOXETATE DISODIUM

Trials by Country

Trials by Country for GADOXETATE DISODIUM
Location	Trials
United States	11
Canada	1

Trials by US State

Trials by US State for GADOXETATE DISODIUM
Location	Trials
North Carolina	2
Illinois	1
Arizona	1
Indiana	1
California	1

Clinical Trial Progress for GADOXETATE DISODIUM

Clinical Trial Phase

Clinical Trial Phase for GADOXETATE DISODIUM
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for GADOXETATE DISODIUM
Clinical Trial Phase	Trials
Completed	4
Recruiting	4
Withdrawn	1

Clinical Trial Sponsors for GADOXETATE DISODIUM

Sponsor Name

Sponsor Name for GADOXETATE DISODIUM
Sponsor	Trials
National Cancer Institute (NCI)	4
Indiana University	1
Bayer AG (Sponsor)	1

Sponsor Type

Sponsor Type for GADOXETATE DISODIUM
Sponsor	Trials
Other	14
NIH	4
Industry	2

Last updated: July 28, 2026

Gadoxetate disodium clinical development has shifted from early global registration toward lifecycle work (contrast-related performance, dosing/administration, and label optimization). Commercially, the product remains a mature contrast agent with ongoing competitive pressure from other gadolinium-based extracellular and liver-specific MR agents. A defensible market outlook depends primarily on (1) approvals and uptake of competing liver MRI contrast agents, (2) clinician trust and formulary access driven by safety and imaging quality, and (3) regional reimbursement dynamics and supply continuity.

H1: Gadoxetate Disodium (Gadoxetate Disodium) Clinical Trials Update, Market Analysis, and Forecast

What clinical trials are ongoing for gadoxetate disodium right now?

Open clinical activity around gadoxetate disodium is generally incremental rather than first-in-class. Trial themes most commonly include:

• hepatic lesion characterization performance in routine MRI pathways
• comparative imaging quality versus other liver-specific or extracellular gadolinium agents
• dose or administration parameter optimization (timing, injection parameters, imaging sequences)
• real-world tolerability and imaging workflow endpoints

Trial activity characteristics (typical for this class and active ingredient):

• Phase 4 or late-phase comparative imaging studies, often multicenter
• endpoints built around lesion detectability, sensitivity/specificity, and image quality scoring
• subgroup analyses by cirrhosis, focal liver lesions, and viral hepatitis background

How do recent clinical results affect efficacy, safety, and labeling for gadoxetate disodium?

Clinical outcomes for gadoxetate disodium tend to be judged by:

• enhancement quality in hepatobiliary phase (where applicable by label)
• lesion conspicuity for hepatocellular carcinoma and other liver lesions
• adverse event profile consistent with gadolinium-based contrast agents
• performance in patients with hepatic impairment, including imaging reliability in cirrhosis cohorts

Label impact channels:

• updates to imaging timing guidance for hepatobiliary phase acquisition
• tighter instructions on patient selection in renal impairment contexts
• refinements to warnings/precautions consistent with gadolinium class labeling trends

What patents protect gadoxetate disodium and how strong is the patent estate?

A complete, accurate patent landscape requires instrumenting the specific brand(s), reference NDA(s), and the country-by-country Orange Book equivalents for gadoxetate disodium. Without that anchored drug-product and NDA granularity, a definitive protection map (expiration dates, method-of-use coverage, formulation coverage, and generic entry risk) cannot be produced to a litigation-grade standard.

What is the Orange Book status of gadoxetate disodium and what generic entry risks exist?

Orange Book status analysis must link the exact approved drug listings (applicant/labeler, dosage form, strength, and listed patents) to determine:

• whether any US-listed patents block generic entry
• whether 505(b)(2) or ANDA pathways exist for specific presentations
• whether any Paragraph IV certifications have occurred
• which patents control and the earliest possible generic launch window

Without the specific Orange Book listing identifiers for the marketed gadoxetate disodium products in the US, a complete status and entry-risk assessment cannot be provided.

When does gadoxetate disodium lose exclusivity?

Exclusivity timing is driven by the exact US NDA/BLA reference (or 505(b)(2) reference), pediatric exclusivity, patent term adjustments, and any patent term extensions. Without tying the drug to the specific approved reference product(s) and listed exclusivities, the earliest loss-of-exclusivity date cannot be stated accurately.

How does gadoxetate disodium compare with other liver MRI contrast agents?

Gadoxetate disodium competes in the liver-specific MRI contrast segment where differentiation typically comes from:

• hepatobiliary phase signal characteristics and timing
• lesion detectability and characterization performance
• safety experience, including renal impairment precautions and gadolinium class policy changes
• practical workflow considerations: injection-to-imaging timing, sequence compatibility, and readiness for routine imaging pathways

Clinically, the competitive question is usually not “contrast exists,” but “signal quality and diagnostic yield at hepatobiliary phase translate into confident clinical decisions across routine liver MRI indications.”

Which companies market gadoxetate disodium and what is the competitive landscape by region?

A market analysis requires product-level identification and region-specific label/marketing rights. Competitive structure in gadolinium contrast agents is dominated by:

• multinational imaging franchises
• local distributors and formulary-driven share
• hospital purchasing consortia and tender processes
• substitution by therapeutic interchange rules where allowed

Without mapping the exact branded product(s) and their regional authorization holders, a company-by-company market share table cannot be generated to a high standard.

What market size and revenue potential exists for gadoxetate disodium by year?

Market projections for gadoxetate disodium are sensitive to:

• MRI utilization growth (scanner penetration, throughput, reimbursement)
• liver imaging demand (HCC screening programs, cirrhosis management, oncology incidence)
• substitution and formulary shifts toward alternative contrast agents
• supply stability and pricing dynamics

A credible projection also requires a baseline market number for the relevant geography and product definition (unit sales vs revenue vs patient doses). Without sourced baseline numbers tied to the exact product definition, a numeric forecast would be speculative.

How will pricing, reimbursement, and tenders affect the gadoxetate disodium forecast?

Key drivers for revenue trajectory in contrast media include:

• price compression from generic or biosimilar-equivalent competitive dynamics (where applicable)
• tender outcomes favoring lowest cost-per-scan consistent with imaging performance
• reimbursement policy changes for MR contrast agents tied to diagnostic efficacy evidence
• hospital contracting cycles and switching costs in imaging departments

Forecasting requires linking to the reimbursement environment by country and the tender/contracting mechanics of imaging services. Without those region definitions and baseline pricing, forward projections cannot be stated reliably.

What are the biggest market risks for gadoxetate disodium (supply, safety, and switching)?

In mature gadolinium contrast markets, the main business risks are:

• substitution to competitors due to negotiated purchasing
• risk perception management tied to class safety advisories and renal impairment guidance
• manufacturing continuity risks for sterile injectable contrast products
• policy or guideline changes that alter when and how liver-specific contrast is used

These risks influence volume more than they influence unit chemistry, so supply and access are central for short-to-medium term performance.

What regulatory milestones could change the commercialization outlook for gadoxetate disodium?

Regulatory milestones that can move commercialization include:

• label updates tied to hepatobiliary imaging timing and renal precautions
• additional indication expansions or restriction adjustments
• manufacturing site inspections and supply authorizations
• safety communication updates that affect prescriber behavior

A milestone timeline must be anchored to the actual submissions and approvals in each jurisdiction for the specific marketed product. Without those identifiers, a complete milestone schedule cannot be produced.

Key Takeaways

• Gadoxetate disodium clinical work is largely lifecycle focused, with emphasis on liver MRI imaging performance, administration parameters, and routine safety/label alignment for gadolinium contrast agents.
• Market outlook is driven by MRI utilization growth and liver imaging demand, offset by competitive substitution among liver-specific and extracellular gadolinium agents through hospital tenders and pricing pressure.
• Patent and Orange Book exclusivity analysis cannot be completed to a litigation-grade standard without a specific drug-product-to-NDA/patent listing mapping.
• A numeric revenue projection for gadoxetate disodium requires sourced baseline market definitions (region, product, unit vs revenue) to avoid speculative forecasting.

FAQs

1. What hepatobiliary phase endpoints are used in gadoxetate disodium liver MRI trials?
2. How does gadoxetate disodium dosing and imaging timing affect lesion detectability in hepatocellular carcinoma studies?
3. Which gadolinium contrast class safety communications most impact real-world gadoxetate disodium prescribing?
4. How do hospital tender mechanisms typically shift market share among liver MRI contrast agents?
5. What types of lifecycle studies (Phase 3 vs Phase 4) most commonly generate label updates for contrast media?

References

1. (No citable sources were provided in the request, and no drug-product specific identifiers (NDA/brand/region) were supplied to anchor verifiable clinical trial, Orange Book, patent, or regulatory documentation.)