CLINICAL TRIALS PROFILE FOR OMNISCAN

All Clinical Trials for OMNISCAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209391 ↗	A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide	Completed	GE Healthcare	Phase 3	2003-09-01	Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.
NCT00209443 ↗	A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide	Completed	GE Healthcare	Phase 3	2004-09-01	Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.
NCT00323102 ↗	A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain	Completed	Bracco Diagnostics, Inc	Phase 4	2006-05-01	This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication
NCT00526188 ↗	Efficacy and Safety of Primovist in Chinese Patients	Completed	Bayer	Phase 3	2007-08-01	Participants who had been diagnosed or suspected by doctors to have focal liver lesions that need further evaluation in order to make an accurate diagnosis. Participants would need to have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further information about the number and characteristics of the focal liver lesions. Participants were invited to take part in this clinical study. The purpose of this study was to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of lesion detection and characterization, and tolerability in Chinese patients with known or suspected focal liver lesions. Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was first approved in 2004 in Sweden followed by an approval in the European community, in Switzerland and Australia in the same year. Procedures: Before entry into the study and after entry of the study a physical examination was conducted, blood pressure and heart rate were measured, blood and urine samples were taken. Current medications and medical conditions (including suspected pregnancy) and medical and surgical history were elicited by doctors. After entry into the study, participants were scheduled to have an MRI examination, which lasted about 25-35 minutes. During the MRI examination, an initial MRI scan without contrast was acquired which followed by another MRI series after the intravenous administration of Primovist. The following day participants were asked to return to the hospital for a follow-up safety evaluation. Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection and characterization of focal liver lesions by providing better contrast between the focal liver lesions and surrounding normal tissue. Primovist were shown to provide additional information regarding existence, number and characterization (lesion or non-lesion, malignant or benign) of these abnormalities. Based on the experience with patients given Primovist, some adverse reactions were observed. Most of undesirable effects were transient and of mild to moderate intensity. The most commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%). All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension; taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting; palpitations, erythema, chest pain and back pain. Coldness, warmth or pain at the injection site, injection site reaction, and injection site accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to shock may occur. Post-marketing tachycardia and restlessness have been reported. As in the case of other investigational drugs, there may also be unforeseen side effects. Additional information concerning all Gadolinium- based contrast agents Primovist contains the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease characterised by formation of connective tissue in the skin, which becomes thickened and hard, sometimes leading to contractures and joint immobility. The clinical course is usually progressive and currently no treatment is available. To date NSF has only been reported in association with some Gd-containing contrast agents, but the role of these contrast agents in the overall pathogenesis of the disease is still not completely understood. No reports of patients with NSF after administration of Primovist® are known. The risk to trigger NSF in risk patients with severe renal impairment is considered to be low for Primovist® due to the low dose given and the additional excretion via feces. Furthermore the participation of patients with severe renal impairment are excluded from this study. In case the participants were suffering from renal insufficiency, they were told to tell their doctors prior to application of the contrast agent. In case the participants experienced any new alterations of the skin following the administration of the contrast agent, they were told to contact their doctors as soon as possible after they had recognized these symptoms.
NCT00908310 ↗	Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)	Completed	i3 Statprobe	Phase 4	2009-05-01	This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
NCT00908310 ↗	Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)	Completed	GE Healthcare	Phase 4	2009-05-01	This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.

Clinical Trial Conditions for OMNISCAN

Condition Name

Condition Name for OMNISCAN
Intervention	Trials
Chronic Kidney Disease	1
Cognitive Function	1
Contrast Media	1
Known or Suspected Focal Liver Lesions	1

Condition MeSH

Condition MeSH for OMNISCAN
Intervention	Trials
Renal Artery Obstruction	1
Renal Insufficiency, Chronic	1
Renal Insufficiency	1
Kidney Diseases	1

Clinical Trial Locations for OMNISCAN

Trials by Country

Trials by Country for OMNISCAN
Location	Trials
United States	6
China	3
Germany	2

Trials by US State

Trials by US State for OMNISCAN
Location	Trials
New Jersey	2
Arizona	1
North Carolina	1
Massachusetts	1
Illinois	1

Clinical Trial Progress for OMNISCAN

Clinical Trial Phase

Clinical Trial Phase for OMNISCAN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3

Clinical Trial Status

Clinical Trial Status for OMNISCAN
Clinical Trial Phase	Trials
Completed	5
Recruiting	1

Clinical Trial Sponsors for OMNISCAN

Sponsor Name

Sponsor Name for OMNISCAN
Sponsor	Trials
GE Healthcare	3
Bracco Diagnostics, Inc	1
Bayer	1

Sponsor Type

Sponsor Type for OMNISCAN
Sponsor	Trials
Industry	7
Other	4

OMNISCAN Market Analysis and Financial Projection

Last updated: April 24, 2026

OMNISCAN (gadoversetamide) clinical trials update and market projection

What is OMNISCAN?

OMNISCAN is a gadolinium-based contrast agent (GBCA) for magnetic resonance imaging (MRI). It is marketed as gadoversetamide injection. The brand is widely used in multiple regulatory markets as a diagnostic imaging agent rather than a disease-modifying therapy.

What do the clinical trials landscape and approvals indicate?

OMNISCAN’s clinical footprint is dominated by registration-era studies and post-marketing pharmacovigilance, rather than a modern pipeline of large, late-stage confirmatory trials typical of therapeutic drugs. The available public record for OMNISCAN centers on:

• Initial comparative efficacy/safety programs that supported regulatory approvals for contrast enhancement in MRI.
• Ongoing label maintenance and safety monitoring activities typical for GBCAs after gadolinium safety scrutiny.
• No widely documented, brand-new phase 3 “pivotal” program that would materially change efficacy claims or expand indications in recent years.

Implication for businesses: OMNISCAN’s clinical value proposition is mature and relatively stable: it is an enabling diagnostic product with competitive pressure largely driven by dosing economics, supply, tendering, formulary decisions, and safety-label positioning for GBCA class risk.

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What clinical trial activity is most relevant to OMNISCAN right now?

Is OMNISCAN tied to active late-stage trials?

There is no widely observable pattern of new, late-stage clinical development for OMNISCAN that would justify a “pipeline-driven” projection (such as new phase 3 readouts, new indications, or line extensions). Clinical relevance comes from:

• Ongoing real-world safety reporting and label updates for GBCA class risk management (not brand-new randomized phase 3 efficacy trials).
• Institutional protocol adoption (dose and patient selection practices) that shift across the GBCA market as guidelines evolve.

What safety and labeling dynamics affect clinical use?

GBCA use is shaped by guidance on nephrogenic systemic fibrosis (NSF) and later concerns about gadolinium deposition. These issues affect ordering behavior and formulary inclusion across hospitals.

Key regulatory and guidance reference points include:

• FDA communications and labeling evolution for GBCAs in the context of NSF risk and gadolinium retention concerns. [1]
• EMA safety communications and restriction-focused guidance for specific GBCA groups. [2]

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How big is the GBCA market and where does OMNISCAN fit?

Where does OMNISCAN sit in the competitive landscape?

OMNISCAN competes within the broader GBCA segment that includes:

• Macrocyclic GBCAs (generally lower gadolinium retention risk in clinical and regulatory discussions)
• Linear GBCAs (associated with higher retention concerns in multiple regulator communications)

Market behavior: Even when efficacy is comparable for MRI contrast enhancement, hospitals bias purchasing toward agents perceived to have lower risk profiles, especially for high-use pathways (nephrology, pediatrics, repeated imaging).

Market drivers

Commercial outcomes in GBCA are driven by:

• MRI utilization growth (volumes)
• Tendering and contracting (pricing and supply)
• Protocol governance (patient selection, repeat dosing, renal function pathways)
• Safety label positioning (adoption and restrictions that can be brand-neutral or class-specific depending on regulator actions)

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What do regulators and guidance say about GBCA risk management?

What are the practical compliance levers?

Regulatory and guideline frameworks translate into hospital-level requirements:

• Renal function screening and risk stratification before GBCA administration
• Avoidance or careful use in patients at higher risk
• Selection of specific GBCA types based on retention and risk categorization

US examples include FDA-related communications for GBCAs and label warnings. [1]
EU examples include EMA communications. [2]

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Clinical trials update summary

Are there new OMNISCAN-specific clinical efficacy results driving adoption?

No credible, widely reported late-stage OMNISCAN-specific efficacy program is apparent in recent public trial registries and regulatory updates. The operational reality for OMNISCAN is:

• Growth depends on MRI volumes and contract retention
• Risk perception and protocol selection depend on GBCA class safety guidance, not new OMNISCAN trial endpoints

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Market analysis and projection for OMNISCAN

How does OMNISCAN revenue typically behave in the GBCA cycle?

For mature imaging brands, revenue usually tracks:

• Imaging demand (MRI procedure counts)
• Share shifts driven by tendering and safety perception
• Competitive substitution across brands with similar diagnostic performance

Because OMNISCAN is not a disease therapeutic, the projection model should treat it as a consumable with protocol and reimbursement sensitivity.

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OMNISCAN market projection framework

Projection approach used here

A practical projection for OMNISCAN should be built on:

1. Volume growth in MRI procedures (long-run CAGR)
2. GBCA penetration and agent mix (macrocyclic vs linear mix shifts)
3. Share stability in key markets under tendering
4. Price and reimbursement dynamics (often compressed by competition)

Given the absence of identifiable new OMNISCAN phase 3 expansion opportunities, the base-case assumes:

• No major label expansion
• Ongoing safety-driven substitution risk versus lower-retention-preference agents
• Incremental volume growth offsets part of share erosion

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Scenario projection (directional, not tied to a single numeric base)

Base case

• OMNISCAN holds core formulary positions in markets where supply and existing procurement contracts remain in place.
• Growth follows MRI volume growth with modest share pressure versus preferred GBCA chemistries.

Downside case

• Faster substitution away from agents perceived as higher retention risk.
• More restrictive institutional protocols reduce utilization in repeated imaging and higher-risk renal cohorts.

Upside case

• Contract wins and formulary renewals in high-volume settings.
• Stable reimbursement without major downward pricing shock in major purchasing regions.

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Key market risks specific to OMNISCAN

1. Safety perception and protocol restriction pressure that can reduce usage in sensitive populations. [1,2]
2. Tendering and supply economics that favor lower-cost alternatives or preferred chemistries.
3. Regulatory and guidance updates that can shift agent selection without changing MRI efficacy requirements. [1,2]

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Opportunities that still move demand

1. Hospital contract retention in radiology departments with established GBCA procurement workflows.
2. Non-ideal substitutes in certain geographies where supply chains and tender awards may keep usage stable longer.
3. Procedural volume growth where overall GBCA use expands faster than substitution.

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Key Takeaways

• OMNISCAN is a mature MRI contrast agent with clinical activity dominated by registration-era evidence and post-marketing safety monitoring, not an active late-stage development cycle.
• The near-term commercial path is driven by MRI utilization, tendering, and hospital protocols shaped by GBCA class safety guidance rather than new OMNISCAN-specific efficacy trials. [1,2]
• Market projections should assume stable but pressured share under safety-driven substitution trends, with growth primarily tracking imaging volume and contracting outcomes.

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FAQs

1) Is OMNISCAN currently in late-stage (phase 3) clinical trials that could change market adoption?
No widely observable late-stage OMNISCAN-specific trial program is evident; the brand’s clinical influence is primarily governed by established indications and safety communications for the GBCA class. [1,2]

2) What most affects OMNISCAN demand in hospitals?
GBCA selection policies tied to renal function screening and retention-risk perceptions, plus radiology procurement and tender decisions. [1,2]

3) Do regulatory safety updates materially change OMNISCAN prescribing?
They can. Even when efficacy remains unchanged, labeling and guidance can shift patient selection and agent preference across GBCA categories. [1,2]

4) Is OMNISCAN growth driven by new indications?
The public record points to no major recent OMNISCAN-driven indication expansion that would function like a therapeutic pipeline catalyst.

5) How should investors or operators model OMNISCAN revenue?
Use a consumable/procedure-volume model with contract and mix-shift assumptions rather than a pipeline-driven S-curve.

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References

[1] U.S. Food and Drug Administration. (n.d.). Drug Safety Communications and labeling information related to gadolinium-based contrast agents (GBCAs). FDA. https://www.fda.gov
[2] European Medicines Agency. (n.d.). EMA safety communications and recommendations on gadolinium-containing contrast agents and related risk management. EMA. https://www.ema.europa.eu