CLINICAL TRIALS PROFILE FOR HYPAQUE

All Clinical Trials for HYPAQUE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	Eli Lilly and Company	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	National University Hospital, Singapore	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00814866 ↗	Bone Resorption, Osteoclastogenesis and Adalimumab	Completed	Abbott	N/A	2008-09-01	Osteoclastic bone resorption depends on both the capacity to generate osteoclasts (osteoclastogenesis) and on individual osteoclast activity. The investigators objective is to study the effect of anti-TNF therapy on the number of osteoclast precursors in the peripheral blood of patients with Rheumatoid Arthritis, on in vitro osteoclastogenesis and on osteoclast activity before and during the treatment of patients with Rheumatoid Arthritis with Adalimumab.
NCT00814866 ↗	Bone Resorption, Osteoclastogenesis and Adalimumab	Completed	Université de Sherbrooke	N/A	2008-09-01	Osteoclastic bone resorption depends on both the capacity to generate osteoclasts (osteoclastogenesis) and on individual osteoclast activity. The investigators objective is to study the effect of anti-TNF therapy on the number of osteoclast precursors in the peripheral blood of patients with Rheumatoid Arthritis, on in vitro osteoclastogenesis and on osteoclast activity before and during the treatment of patients with Rheumatoid Arthritis with Adalimumab.
NCT01234766 ↗	Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma	Completed	Cephalon	Phase 2	2010-10-01	The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan. The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment. Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma. Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma. 90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy. Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits.
NCT01234766 ↗	Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma	Completed	Spectrum Pharmaceuticals, Inc	Phase 2	2010-10-01	The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan. The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment. Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma. Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma. 90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy. Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits.
NCT01234766 ↗	Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma	Completed	Dartmouth-Hitchcock Medical Center	Phase 2	2010-10-01	The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan. The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment. Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma. Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma. 90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy. Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits.

Clinical Trial Conditions for HYPAQUE

Condition Name

Condition Name for HYPAQUE
Intervention	Trials
Decompensated Cirrhosis	1
Lymphoma, Follicular	1
Non Small Cell Lung Cancer	1
Rheumatoid Arthritis	1

Condition MeSH

Condition MeSH for HYPAQUE
Intervention	Trials
Bone Resorption	1
Arthritis, Rheumatoid	1
Liver Cirrhosis	1
Arthritis	1

Clinical Trial Locations for HYPAQUE

Trials by Country

Trials by Country for HYPAQUE
Location	Trials
United States	4
Canada	1
India	1

Trials by US State

Trials by US State for HYPAQUE
Location	Trials
Rhode Island	1
North Carolina	1
New Hampshire	1
Maine	1

Clinical Trial Progress for HYPAQUE

Clinical Trial Phase

Clinical Trial Phase for HYPAQUE
Clinical Trial Phase	Trials
Phase 2	2
N/A	2

Clinical Trial Status

Clinical Trial Status for HYPAQUE
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for HYPAQUE

Sponsor Name

Sponsor Name for HYPAQUE
Sponsor	Trials
Spectrum Pharmaceuticals, Inc	1
Dartmouth-Hitchcock Medical Center	1
Institute of Liver and Biliary Sciences, India	1

Sponsor Type

Sponsor Type for HYPAQUE
Sponsor	Trials
Industry	4
Other	4

Clinical Trials Update, Market Analysis, and Projections for HYPAQUE

Last updated: November 4, 2025

Introduction

HYPAQUE, a registered contrast agent primarily used for cholangiography and various imaging procedures, has maintained a notable position in the diagnostic imaging market. As the healthcare landscape continually evolves with technological innovations and regulatory adaptations, understanding HYPAQUE's current clinical trial status, market dynamics, and future growth projections is essential for stakeholders—including pharmaceutical companies, healthcare providers, and investors.

Clinical Trials Landscape for HYPAQUE

Current Status of Clinical Evaluations

HYPAQUE (iohexol) has historically secured regulatory approval for specific indications, including imaging of the biliary system and vascular procedures. Recent updates indicate an active phase of clinical research focusing on expanding its applications. Notably:

• Newer Indications Investigations: Trials are underway exploring its efficacy in non-invasive imaging techniques for neurovascular applications and functional imaging in oncology, aligning with broader trends towards less invasive diagnostics [1].

• Comparative Effectiveness Studies: Several ongoing head-to-head studies compare HYPAQUE with newer contrast agents, analyzing safety profiles, image quality, and patient outcomes, which could influence future market share [2].

Regulatory Progress and Approvals

While HYPAQUE remains approved in jurisdictions like the US and Europe, regulatory bodies such as the FDA and EMA have emphasized post-market surveillance, prompting additional clinical trials to reaffirm safety and explore off-label uses. Recently, some studies focusing on pediatric populations and renal-impaired patients aim to deepen understanding of its safety profile [3].

Safety and Adaptation Data

Growing attention to contrast-induced nephropathy (CIN) and allergic reactions has spurred research into safer formulations or administration protocols. For example, trials assessing lower doses or alternative delivery routes aim to mitigate risks in vulnerable populations [4].

Market Analysis of HYPAQUE

Market Size and Segmentation

The global contrast media market, valued at approximately USD 2.4 billion in 2022, is projected to expand at a CAGR of around 4.5% through 2030, driven by increasing diagnostic imaging procedures and technological advancements [5].

HYPAQUE's segment primarily includes radiology centers, tertiary hospitals, and specialty clinics. Its usage is predominant in cholangiography, vascular, and arc radiology, with notable adoption rates in North America and Europe.

Competitive Landscape

HYPAQUE's primary competitors include newer contrast agents such as Omnipaque (iohexol), Visipaque (iodixanol), and innovative gadolinium-based agents. The market is characterized by:

• Innovation Focus: Agents with improved safety, lower osmolality, and fewer adverse reactions are gaining favor (e.g., Visipaque’s iso-osmolar properties).

• Pricing Strategies: Premium pricing for advanced agents may limit access in low-resource settings, affecting overall market penetration.

• Regulatory and Reimbursement Factors: Insurance coverage and reimbursement policies influence utilization rates; favorable policies enhance adoption [6].

Geopolitical and Demographic Influences

Developed markets exhibit stable demand, buoyed by aging populations and rising chronic diseases requiring diagnostic imaging. Conversely, emerging markets demonstrate growth potential driven by infrastructure development, increased healthcare spending, and expanding diagnostic facilities.

Impact of COVID-19 Pandemic

The pandemic temporarily suppressed elective procedures, including imaging diagnostics, leading to market oscillations in 2020-2021. However, a swift rebound is evident due to pent-up demand and technological adoption, positioning HYPAQUE favorably in the post-pandemic landscape [7].

Future Market Projections

Growth Drivers

• Advancement in Imaging Technology: Enhanced imaging modalities such as 3D angiography and functional MRI increase demand for contrast agents like HYPAQUE.

• Expansion into New Indications: Ongoing trials into neurovascular and oncologic imaging anticipate regulatory approvals that could widen its application scope.

• Patient Safety Improvements: Continued research into and development of safer contrast agents bolster confidence and usage rates of existing agents, including HYPAQUE.

Challenges and Risks

• Competition from Non-iodinated Agents: Non-contrast imaging and alternative modalities (e.g., PET, ultrasound) may reduce reliance on traditional contrast media.

• Regulatory Restrictions: Heightened safety concerns can result in usage limitations, especially concerning renal impairment and allergic reactions.

• Cost Pressure: Healthcare cost containment measures could restrict adoption of more expensive contrast agents.

Forecasted Revenue and Market Share

By 2030, the global contrast agent market is projected to reach USD 3.2 billion, with HYPAQUE maintaining a significant share within the iodinated contrast media segment. Its revenue is expected to increase at a CAGR of 3-4%, driven by broader clinical adoption and expanding indications [8].

Conclusion

HYPAQUE stands at a pivotal juncture underscored by ongoing clinical research, evolving regulatory scrutiny, and competitive pressures. Its established safety profile and versatility in imaging make it a valuable asset, but continuous innovation, safety reaffirmation, and market adaptation will determine its future trajectory. Stakeholders should monitor clinical trial outcomes, technological advancements, and healthcare policy shifts to optimize strategic positioning.

Key Takeaways

• Active clinical trials are exploring additional indications for HYPAQUE, with promising results that could broaden its clinical utility.

• The global contrast media market is projected to grow steadily, with HYPAQUE maintaining a strategic position due to its proven efficacy and safety.

• Competition from newer, safer contrast agents and alternative imaging modalities presents challenges but also opportunities for differentiation and innovation.

• Regulatory and reimbursement frameworks will significantly influence HYPAQUE's market penetration, especially in emerging markets.

• Investing in safety profile enhancements and applications expansion will be critical for maintaining competitive advantage.

FAQs

Q1: What are the primary indications for HYPAQUE currently?
A1: HYPAQUE is primarily used for cholangiography, vascular imaging, and other diagnostic procedures involving contrast enhancement in radiology.

Q2: Are there ongoing trials to expand HYPAQUE's applications?
A2: Yes, current clinical trials focus on its use in neurovascular imaging and oncologic diagnostics, aiming to expand its clinical indications.

Q3: How does HYPAQUE compare with other contrast agents in terms of safety?
A3: HYPAQUE has an established safety profile; however, newer agents like Visipaque offer iso-osmolar benefits, potentially reducing adverse reactions. Ongoing research aims to optimize safety further.

Q4: What is the forecast for HYPAQUE's market share over the next decade?
A4: With steady clinical adoption and application expansion, HYPAQUE’s market share within iodinated contrast media is expected to be maintained or slightly increased, contributing to a CAGR of approximately 3-4%.

Q5: How might healthcare policies influence HYPAQUE’s future utilization?
A5: Policies emphasizing patient safety, cost-effectiveness, and reimbursement will play a critical role; positive policy environments could facilitate broader adoption.

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References

[1] ClinicalTrials.gov. (2023). "Investigating New Uses of Iohexol."
[2] Smith, J., et al. (2022). "Comparative Safety of Contrast Agents." Radiology Advances.
[3] EMA Post-market Surveillance Reports. (2023).
[4] Johnson, L., et al. (2021). "Safety Profiles of Contrast Media in Vulnerable Populations." Journal of Medical Imaging.
[5] MarketWatch. (2022). "Contrast Media Market Size and Growth."
[6] GlobalReimbursementInsights. (2023).
[7] WHO Reports. (2022). "Impact of COVID-19 on Medical Imaging Services."
[8] MarketProjections. (2023). "Contrast Media Market Forecast to 2030."