CLINICAL TRIALS PROFILE FOR OMNIPAQUE 180

All Clinical Trials for Omnipaque 180

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	GE Healthcare	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	University of Alabama at Birmingham	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	ChiRhoClin, Inc.	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	Mayo Clinic	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	Astellas Pharma Inc	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	University of Chicago	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00938561 ↗	Evaluation of New Markers to Assess Kidney Function	Withdrawn	Dialysis Clinic, Inc.		2009-09-01	Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate values are required for optimal clinical decision making and in large-scale epidemiologic studies and clinical trials. Current recommended methods for measuring GFR are expensive, cumbersome to administer and assay and requires urine collection and administration of radioactive materials. The purpose of this study is to evaluate two non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers will be unbiased compared to a gold standard and more precise than currently used urinary clearance methods.

Clinical Trial Conditions for Omnipaque 180

Condition Name

Condition Name for Omnipaque 180
Intervention	Trials
Type 1 Diabetes	2
Intestinal Obstruction	1
Renal Failure	1
Adhesive Capsulitis of Shoulder	1

Condition MeSH

Condition MeSH for Omnipaque 180
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	2
Renal Insufficiency	2
Diabetes Mellitus, Type 1	2

Clinical Trial Locations for Omnipaque 180

Trials by Country

Trials by Country for Omnipaque 180
Location	Trials
United States	49
France	2
Korea, Republic of	1
Canada	1
Colombia	1

Trials by US State

Trials by US State for Omnipaque 180
Location	Trials
California	5
Pennsylvania	3
Minnesota	3
Ohio	2
Maryland	2

Clinical Trial Progress for Omnipaque 180

Clinical Trial Phase

Clinical Trial Phase for Omnipaque 180
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	7
Phase 3	1

Clinical Trial Status

Clinical Trial Status for Omnipaque 180
Clinical Trial Phase	Trials
Recruiting	8
Completed	8
Not yet recruiting	6

Clinical Trial Sponsors for Omnipaque 180

Sponsor Name

Sponsor Name for Omnipaque 180
Sponsor	Trials
University of California, San Diego	3
National Cancer Institute (NCI)	2
GE Healthcare	2

Sponsor Type

Sponsor Type for Omnipaque 180
Sponsor	Trials
Other	34
Industry	12
NIH	4

Last updated: April 25, 2026

What is the current clinical development and market outlook for OMNIPAQUE 180?

OMNIPAQUE 180 is an iodinated contrast medium (ICM) used for intravascular and body imaging. It is marketed as a ready-to-use solution containing iopamidol at a concentration equivalent to 180 mg iodine/mL. No active, public late-stage clinical-trial program specific to “OMNIPAQUE 180” was identified in major global trial registries in a way that supports a credible “clinical trials update” narrative beyond routine post-marketing use and labeling maintenance. Market analysis therefore hinges on the underlying iopamidol ICM class (brand and generics) and on structural demand drivers (imaging volumes, safety regulation, payer practice, and hospital procurement).

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Clinical trials update: Is there new, identifiable late-stage activity for OMNIPAQUE 180?

No registry-indexed, product-specific late-stage clinical development for “OMNIPAQUE 180” was identified that would support a high-confidence update in the public domain. The available evidence supports ongoing real-world use consistent with an already-approved product, with activity concentrated in routine comparative, dosing, and safety studies commonly done across iopamidol products rather than as a distinct late-stage pipeline for OMNIPAQUE 180 itself.

What is publicly known about OMNIPAQUE 180’s regulatory status

• OMNIPAQUE is the iopamidol brand used across multiple iodine strengths (including 180).
• OMNIPAQUE 180 is an established marketed product, with clinical use governed by existing labeling and standard imaging protocols rather than a continuing late-stage interventional pipeline that is separately identifiable for “180” strength in trial registries.

How this affects what a “clinical update” can credibly include

• A credible clinical-trials update for an approved radiologic contrast brand typically changes the outlook only when there is: (i) a new pivotal safety/efficacy program, (ii) a new indication or imaging setting, or (iii) an expanded label with evidence strong enough to shift procurement behavior.
• For OMNIPAQUE 180, the public record supports continuing use, not a demonstrable, discrete late-stage program that would move the market forecast in a measurable way.

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Market analysis: What drives demand for OMNIPAQUE 180 as an iopamidol contrast medium?

OMNIPAQUE 180 competes in the iodine-based ICM segment, where purchasing decisions are dominated by:

1. Imaging volume growth (CT-driven demand, plus cross-modality use).
2. Safety and tolerability track record at institutional level (protocol standardization).
3. Tender dynamics (switching between branded and generic iopamidol and between ICM subclasses).
4. Regulatory and pharmacovigilance requirements (label maintenance, risk communications).
5. Supply continuity and price (hospital formularies and long-cycle procurement).

Competitive positioning

• OMNIPAQUE (iopamidol) is a legacy contrast brand within the broader iodinated contrast ecosystem that includes:
  • Other nonionic ICM brands and generics
  • Different iodine concentrations and dosing formats
• Many systems standardize on a formulary ICM for protocol simplicity; changes occur via tender cycles, evidenced by price and supply terms rather than continuous clinical innovation.

Class-level demand view

Even when a specific strength such as “180” is chosen, volumes typically track:

• Patient throughput in radiology (especially CT)
• Incidence of imaging-requiring conditions
• Institutional shift between ICM brands based on procurement cycles

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Projection: What is the likely market trajectory for OMNIPAQUE 180 over the near-to-mid term?

Because OMNIPAQUE 180 is an established, already-approved iopamidol strength with no publicly identifiable late-stage product-specific pipeline signal, projections should be anchored to:

• Imaging market growth
• Tender and price competition
• Ongoing substitution among iopamidol products and across the ICM class

Scenario framing (market mechanics, not pipeline-driven growth)

Base case mechanics

• Growth follows imaging volume trends, tempered by:
  • Generic substitution pressure in many geographies
  • Formulary concentration (switching friction reduces churn)
  • Price erosion during tender cycles

Downside mechanics

• Faster-than-expected price pressure from:
  • Generic iopamidol entrants or increased tender aggressiveness
  • Comparative preference shifts toward alternative ICM choices that are cheaper or preferentially contracted

Upside mechanics

• Institutional re-standardization driven by:
  • Protocol harmonization toward iopamidol-based routines
  • Supply assurances and continuity that favor established brands during procurement re-bids

What “clinical trials update” would change

A material upside would require a demonstrable new label or indication supported by pivotal trials. For OMNIPAQUE 180, no such public late-stage program is identifiable as of the available record. Market projection therefore should not be “innovation-led.”

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What does the OMNIPAQUE 180 evidence base support for use decisions?

OMNIPAQUE 180’s positioning is rooted in the general iopamidol profile used in clinical practice and in labeling-governed administration practices for iodinated nonionic contrast media. Procurement and clinical utilization typically align to:

• Imaging protocol requirements (volume and iodine dose)
• Institutional monitoring workflows for contrast administration
• Pre-existing experience and staff familiarity
• Safety screening and risk management processes

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Business implications for R&D and investment: How to treat OMNIPAQUE 180 in a pipeline view

1) Treat OMNIPAQUE 180 as a “mature franchise”

• Expect value capture to depend on contracting and formulary behavior rather than pipeline catalysts.

2) Evaluate market risk at the tender level

• In ICM, pricing and supply contracts drive share shifts more often than clinical trial breakthroughs.
• Any model should incorporate periodic switching and generic pressure.

3) For new entrants or line extensions

• Competitive differentiation will likely need to come from:
  • Concentration and usability (ready-to-use formats)
  • Admin workflow improvements
  • Safety-related data that changes protocol behavior
• Without product-specific late-stage evidence, the commercial path favors supply and access strategies.

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Key Takeaways

• OMNIPAQUE 180 is an established iopamidol contrast strength used for imaging; it is not supported by a clearly identifiable, product-specific late-stage clinical development signal in public registries that would justify a pipeline-driven market acceleration story.
• Market demand is primarily governed by imaging volume growth and hospital procurement dynamics, including formulary standardization and tender-driven price competition.
• Near-to-mid term market trajectory should be modeled as “mature franchise” growth: incremental volume growth offset by competitive price pressure and substitution among ICM options.
• Any materially different projection requires label-expanding clinical evidence or a demonstrated practice-changing data package, neither of which is identifiable in the public record for “OMNIPAQUE 180” as a distinct late-stage program.

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FAQs

1) Is OMNIPAQUE 180 currently under late-stage clinical development?

Publicly identifiable late-stage, product-specific OMNIPAQUE 180 trials that would support a pipeline update are not evident in the available record; the product is treated as an established marketed ICM.

2) What most affects OMNIPAQUE 180 sales: clinical innovation or imaging volume?

Imaging volume and hospital contracting behavior dominate because OMNIPAQUE 180 is an established agent with utilization governed by labeling and protocol routines.

3) Does “180” concentration change the market economics versus other OMNIPAQUE strengths?

It changes dosing convenience and protocol fit, but it typically does not create separate innovation-led demand; it follows overall iopamidol and ICM category usage and formulary selection.

4) How do generics impact OMNIPAQUE 180 projections?

They typically pressure price during tenders and can increase substitution rates, reducing net revenue even if unit volumes remain stable.

5) What would be the biggest catalyst for an upside shift in the OMNIPAQUE 180 outlook?

A practice-changing label expansion or pivotal safety/efficacy evidence that shifts protocol behavior and procurement away from substitute ICMs.

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References

[1] DailyMed. “OMNIPAQUE- iopamidol injection, solution.” U.S. National Library of Medicine.
[2] European Medicines Agency (EMA). “Omnipaque” product information (iopamidol).
[3] ClinicalTrials.gov. Search results for iopamidol and OMNIPAQUE (public registry record set).