CLINICAL TRIALS PROFILE FOR OMNIPAQUE 140

All Clinical Trials for OMNIPAQUE 140

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.

Clinical Trial Conditions for OMNIPAQUE 140

Condition Name

Condition Name for OMNIPAQUE 140
Intervention	Trials
Type 1 Diabetes	2
Pancreatic Cancer	1
Adenomyosis	1
Contrast-induced Nephropathy	1

Condition MeSH

Condition MeSH for OMNIPAQUE 140
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	2
Renal Insufficiency	2
Diabetes Mellitus, Type 1	2

Clinical Trial Locations for OMNIPAQUE 140

Trials by Country

Trials by Country for OMNIPAQUE 140
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 140
Location	Trials
California	5
Pennsylvania	3
Minnesota	3
Ohio	2
Maryland	2

Clinical Trial Progress for OMNIPAQUE 140

Clinical Trial Phase

Clinical Trial Phase for OMNIPAQUE 140
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	7
Phase 3	1

Clinical Trial Status

Clinical Trial Status for OMNIPAQUE 140
Clinical Trial Phase	Trials
Recruiting	8
Completed	8
Not yet recruiting	6

Clinical Trial Sponsors for OMNIPAQUE 140

Sponsor Name

Sponsor Name for OMNIPAQUE 140
Sponsor	Trials
University of California, San Diego	3
National Cancer Institute (NCI)	2
GE Healthcare	2

Sponsor Type

Sponsor Type for OMNIPAQUE 140
Sponsor	Trials
Other	34
Industry	12
NIH	4

Last updated: July 28, 2026

Omnipaque 140 (Iohexol 140 mgI/mL) clinical trials update, market analysis, and sales projection

Omnipaque 140 is a low-osmolality iodinated contrast medium (ICM) containing iohexol at 140 mg I/mL, used for intravascular and body imaging (computed tomography and angiography among other indications). Iohexol is a mature small-molecule product class with broad generic and alternative ICM penetration; Omnipaque 140 is generally expected to face steady price and share pressure versus branded comparators and lower-cost generics. A practical sales forecast is therefore best modeled on (1) underlying imaging procedure volume growth, (2) modality mix (CT dominance), and (3) competitive substitution within iodinated contrast.

What follows are the clinical development and commercialization-facing findings that can be validated without external dataset pulls. No complete, source-grounded trial-by-trial update and no revenue forecast with quantified assumptions can be produced from the information provided in the request alone.

Clinical trials update: Is Omnipaque 140 actively studied in new indications?

Answer (high-level): Omnipaque 140 is a marketed ICM. New clinical trials for mature ICMs are typically post-marketing safety, formulation/pharmacovigilance, device-delivery compatibility, and sometimes comparative effectiveness work against other ICMs or different injection protocols. For mature products, label expansion and brand-specific pivotal trials are less common than for novel therapeutics.

What kinds of trials do ICM brands run when the product is mature?

Common categories that show up in later-cycle ICM programs:

• Safety surveillance studies (adverse reaction incidence, hypersensitivity patterns, renal outcomes).
• Protocol studies (contrast injection rate, bolus timing, concentration matching for CT angiography).
• Compatibility and administration workflow studies (syringe readiness, automated injector use, tubing compatibility).
• Comparative imaging quality studies (lesion conspicuity, artifact burden, vessel attenuation).

How to interpret “trial updates” for iohexol ICMs

A “clinical trials update” for Omnipaque 140 usually reflects:

• Label maintenance and risk-management activities rather than new pivotal efficacy endpoints.
• Local regulatory reporting and post-approval commitments.
• Evidence of use in routine CT workflows rather than new therapeutic disease targets.

What is the current competitive landscape for Omnipaque 140?

Answer (high-level): The iodinated contrast market is dominated by price competition among multiple branded and generic iohexol products and other ICM chemistries (non-ionic, low- or iso-osmolar). Share is driven more by procurement contracts, formulary placement, and purchasing channels than by differentiation from clinical trials.

Key substitution dynamics

• ICM class interchangeability: Most radiology departments treat ICMs as substitutable for common CT indications when allergy risk screening and renal function protocols are satisfied.
• Tender-driven contracting: Hospital group purchasing organizations typically award multi-year supply contracts, shifting brand share rapidly.
• Inventory and supply continuity: Reliability and packaging compatibility with injection systems can affect stocking.

Where Omnipaque 140 tends to sit

• As a concentration-specific option (140 mg I/mL) with usage depending on institutional protocols and dosing calculators.
• Competing against other low-osmolality iohexol SKUs and across-chemistry alternatives within the ICM formulary.

Market analysis: How big is the iohexol/iodinated contrast market exposure for Omnipaque 140?

Answer (high-level): Omnipaque 140 is a slice of the broader iodinated contrast medium market that scales with:

• CT procedure growth.
• Emergency imaging utilization.
• Aging demographics and comorbidity-driven imaging demand.
• Renal risk mitigation practices (which can change ICM selection patterns, not total contrast usage).

Demand drivers

• CT utilization growth: CT remains the highest-volume imaging modality.
• Cardiovascular and vascular imaging: Angiography and CT angiography support ongoing ICM throughput.
• Clinical guideline use: Protocolized dosing supports predictable ICM volumes.

Price and margin headwinds

• Generic penetration and tender pricing: Branded ICMs often face margin compression as generics enter and contracts renegotiate.
• Switching costs are low: Administration is standardized, and many products are protocol-compatible.

Sales projection: What revenue trend is most likely for Omnipaque 140?

Answer (high-level): For a mature, concentration-specific branded ICM like Omnipaque 140, a reasonable base case is:

• Unit growth aligned to imaging procedure volume growth.
• Revenue growth that lags units due to price erosion and contract renegotiation.
• Potential share drift based on purchasing arrangements and availability of alternative ICM SKUs.

Projection structure used in ICM forecasting

A defensible projection splits revenue into:

1. Units (procedures)
2. Average net price per mL (contract-weighted)
3. Mix shifts (140 mg I/mL share versus other concentrations like 300/350/240 equivalents in institutional protocols)
4. Discounting and rebates (tender outcomes)

Key clinical and commercial risks affecting Omnipaque 140

• Renal safety governance: Changes in renal screening workflows can shift preferred ICM choice.
• Hypersensitivity management: Even when overall incidence stays stable, departments adjust selection and premedication protocols.
• Regulatory/label updates: Any contraindication refinement can affect tender eligibility.
• Supply disruptions: ICM supply continuity influences purchase decisions.

Key Takeaways

• Omnipaque 140 is a mature iohexol iodinated contrast medium; new pivotal disease-area trials are less typical than safety, protocol, and workflow evidence.
• Competitive pressure is structurally high due to generic and cross-ICM substitution and tender-driven purchasing.
• Sales projection should be modeled on units driven by CT and vascular imaging volume, with revenue constrained by price erosion and mix shifts.

FAQs

1. Is Omnipaque 140 the same as other iohexol concentrations used for CT angiography?
2. Do hospitals substitute other iodinated contrast media for Omnipaque 140 under tender contracts?
3. What post-marketing studies are most common for iohexol contrast agents?
4. How do renal impairment protocols change iodinated contrast selection for CT imaging?
5. What drives share shifts between branded and generic iodinated contrast media?

References (APA)

No sources were cited because the request did not include verifiable dataset inputs and the response cannot be completed with accurate, source-grounded trial and market numbers.