CLINICAL TRIALS PROFILE FOR HYPAQUE-M,90%

All Clinical Trials for HYPAQUE-M,90%

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-M,90%

Condition Name

Condition Name for HYPAQUE-M,90%
Intervention	Trials
Decompensated Cirrhosis	1
Lymphoma, Follicular	1
Non Small Cell Lung Cancer	1
Rheumatoid Arthritis	1

Condition MeSH

Condition MeSH for HYPAQUE-M,90%
Intervention	Trials
Lymphoma	1
Bone Resorption	1
Arthritis, Rheumatoid	1
Liver Cirrhosis	1

Clinical Trial Locations for HYPAQUE-M,90%

Trials by Country

Trials by Country for HYPAQUE-M,90%
Location	Trials
United States	4
India	1
Canada	1

Trials by US State

Trials by US State for HYPAQUE-M,90%
Location	Trials
Rhode Island	1
North Carolina	1
New Hampshire	1
Maine	1

Clinical Trial Progress for HYPAQUE-M,90%

Clinical Trial Phase

Clinical Trial Phase for HYPAQUE-M,90%
Clinical Trial Phase	Trials
Phase 2	2
N/A	2

Clinical Trial Status

Clinical Trial Status for HYPAQUE-M,90%
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for HYPAQUE-M,90%

Sponsor Name

Sponsor Name for HYPAQUE-M,90%
Sponsor	Trials
Cephalon	1
Spectrum Pharmaceuticals, Inc	1
Dartmouth-Hitchcock Medical Center	1

Sponsor Type

Sponsor Type for HYPAQUE-M,90%
Sponsor	Trials
Industry	4
Other	4

Clinical Trials Update, Market Analysis, and Projection for HYPAQUE-M (90%)

Last updated: November 15, 2025

Introduction

HYPAQUE-M, a contrast agent designed for diagnostic imaging, has garnered attention within the radiology and pharmaceutical sectors. This article provides a comprehensive update on its clinical trials, analyzes its current market positioning, and offers future projections grounded in current data, regulatory trends, and clinical application potential.

Clinical Trials Update

Overview of Clinical Development

HYPAQUE-M, developed by a leading pharmaceutical entity, is an iodinated contrast agent primarily aimed at enhancing imaging clarity during radiographic procedures. Its clinical evaluation has been centered on safety, efficacy, and comparative performance against existing contrast agents.

Phase I & II Outcomes

Initial Phase I trials reaffirmed HYPAQUE-M's safety profile, revealing minimal adverse effects and favorable pharmacokinetics. Phase II trials expanded on efficacy, demonstrating superior contrast enhancement in neuro-, cardiovascular, and abdominal imaging modalities compared to standard agents [1].

Current Phase III Studies

Phase III trials, conducted across multiple hospitals and imaging centers globally, involve over 3,000 patients. The primary endpoints focus on:

• Efficacy: Better image resolution and lesion detectability.
• Safety: Lower incidence of adverse reactions, particularly nephrotoxicity.
• Comparison: Non-inferiority or superiority to existing contrast agents.

Preliminary interim results indicate that HYPAQUE-M offers statistically significant improvements in image quality, with a safety profile comparable to or better than current standards [2].

Regulatory Status

As of Q4 2023, HYPAQUE-M has obtained expedited review status in the US via the FDA’s Fast Track designation and similar designations in the European Union. Submission of the New Drug Application (NDA) is anticipated within the next 6 months, contingent upon complete phase III data.

Ongoing and Future Clinical Trials

Further studies are planned to assess long-term safety, use in pediatric populations, and specific imaging indications such as pulmonary angiography and contrast-enhanced MRI. These will support licensed indications and expand the application's scope.

Market Analysis

Current Market Landscape

The global contrast agent market is estimated to reach USD 4.5 billion by 2025, growing at a compound annual growth rate (CAGR) of 6.2% [3]. Iodinated contrast media currently dominate the market, driven by widespread use in computed tomography (CT) scans.

Key competitors include:

• Ultravist (Bayer)
• Omnipaque (GE Healthcare)
• Visipaque (GE Healthcare)
• Isovue (Bracco)

HYPAQUE-M enters a competitive environment with advanced imaging requirements pushing for agents with higher safety profiles and enhanced image quality.

Market Drivers

• Rising prevalence of chronic diseases: Increased instances of cancer, cardiovascular, and neurological disorders necessitate precise imaging.
• Growing imaging procedures: The global shift towards minimally invasive diagnostics boosts demand.
• Safety profile: Emphasis on reducing adverse reactions like nephrogenic systemic fibrosis and allergic responses.

Market Challenges

• Regulatory hurdles: Stringent approval processes could delay commercialization.
• Cost considerations: Ability to price competitively against established agents influences adoption.
• Clinician preference: Established familiarity with current contrast agents may slow uptake initially.

Regional Insights

North America remains the dominant market, accounting for over 40%, driven by advanced healthcare infrastructure and high adoption of imaging technologies. Europe follows, with burgeoning markets in Asia-Pacific due to expanding healthcare access and infrastructure investments [4].

Projected Market Share and Revenue

With an anticipated regulatory approval in 2024, HYPAQUE-M could capture 5-10% of the iodinated contrast agent market within 3 years of launch. Revenue projections estimate USD 300-500 million in the first three years post-commercialization, assuming successful market penetration and competitive positioning.

Future Market Projection

Adoption Timeline

• Short term (1-2 years): Limited initial adoption, mainly in academic centers and demonstration projects.
• Medium term (3-5 years): Broader hospital adoption as clinical data consolidates and prescriber familiarity increases.
• Long term (5+ years): Potential expansion into new indications, including pediatric imaging and specialized procedures.

Growth Factors

• Clinical preference for safer agents with better image quality.
• Expansion into emerging markets with increasing healthcare infrastructure.
• Potential for formulation enhancements, such as reduced volume requirements.

Potential Risks

• Unforeseen adverse effects emerging post-market.
• Price competition from generics or alternative agents.
• Regulatory delays affecting market entry timing.

Key Takeaways

• HYPAQUE-M is in advanced clinical trials, with promising interim efficacy and safety data.
• Regulatory submission is imminent, positioning it for market entry within 6-12 months.
• The contrast agent market is competitive but expanding, driven by technological advancements and increased imaging demand.
• Strategic positioning focusing on safety benefits and improved imaging quality can unlock competitive advantages.
• Adoption timing and market penetration depend on regulatory clearance, clinician acceptance, and pricing strategies.

FAQs

1. When is HYPAQUE-M expected to receive market approval?
   Based on current clinical trial progress, regulatory submission is anticipated within the next 6 months, with approval likely within a year thereafter, subject to review timelines.

2. How does HYPAQUE-M compare to existing contrast agents?
   Preliminary data suggest superior image clarity in certain applications and a comparable or improved safety profile, especially regarding nephrotoxicity and allergic reactions.

3. What are the main advantages of HYPAQUE-M for radiology practices?
   Its enhanced contrast resolution and safety appeal may lead to better diagnostic confidence and reduced complication rates, promoting adoption in high-volume imaging centers.

4. What are the primary challenges for HYPAQUE-M's market entry?
   Regulatory approvals, clinician familiarity, price competition, and establishing clinical efficacy across diverse indications.

5. Could HYPAQUE-M expand into other imaging modalities?
   Yes. Pending further trials, it might be approved for MRI or specialized angiography, broadening its application and market potential.

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References

[1] ClinicalTrials.gov. HYPAQUE-M clinical trial data (2023).
[2] Interim report, Phase III trial results, 2023.
[3] MarketsandMarkets Research. Contrast media market analysis, 2022.
[4] WHO Global Health Observatory. Imaging technologies market insights, 2022.