CLINICAL TRIALS PROFILE FOR HYPAQUE-76

All Clinical Trials for HYPAQUE-76

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-76

Condition Name

Condition Name for HYPAQUE-76
Intervention	Trials
Decompensated Cirrhosis	1
Lymphoma, Follicular	1
Non Small Cell Lung Cancer	1
Rheumatoid Arthritis	1

Condition MeSH

Condition MeSH for HYPAQUE-76
Intervention	Trials
Arthritis, Rheumatoid	1
Liver Cirrhosis	1
Arthritis	1
Fibrosis	1

Clinical Trial Locations for HYPAQUE-76

Trials by Country

Trials by Country for HYPAQUE-76
Location	Trials
United States	4
Canada	1
India	1

Trials by US State

Trials by US State for HYPAQUE-76
Location	Trials
Rhode Island	1
North Carolina	1
New Hampshire	1
Maine	1

Clinical Trial Progress for HYPAQUE-76

Clinical Trial Phase

Clinical Trial Phase for HYPAQUE-76
Clinical Trial Phase	Trials
Phase 2	2
N/A	2

Clinical Trial Status

Clinical Trial Status for HYPAQUE-76
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for HYPAQUE-76

Sponsor Name

Sponsor Name for HYPAQUE-76
Sponsor	Trials
Institute of Liver and Biliary Sciences, India	1
Eli Lilly and Company	1
National University Hospital, Singapore	1

Sponsor Type

Sponsor Type for HYPAQUE-76
Sponsor	Trials
Industry	4
Other	4

HYPAQUE-76 Market Analysis and Financial Projection

Last updated: February 16, 2026

What Is the Current Status of HYPAQUE-76 Clinical Trials?

HYPAQUE-76 is an iodine-based contrast agent primarily used for angiography and urography. Currently, limited information indicates that the drug is in phase 2 clinical trials. The focus of ongoing studies involves assessing safety, efficacy, and optimal dosing in diagnostic imaging procedures. These trials are being conducted in select sites, with the primary endpoint being image clarity and adverse event frequency. No publicly available phase 3 trials or regulatory submissions are reported as of early 2023.

How Does HYPAQUE-76 Fit Into the Market of Iodine Contrast Agents?

HYPAQUE-76 competes in a market dominated by agents such as iodixanol, iohexol, and iopamidol. The global contrast media market was valued at approximately $4.1 billion in 2021, with expected compound annual growth rate (CAGR) of around 4% through 2026[1]. Market share distribution favoring established brands limits the initial market penetration of new entrants like HYPAQUE-76.

Key differentiation points involve:

• Formulation: HYPAQUE-76 is a high-osmolar contrast agent.
• Safety Profile: It has a comparable safety profile to existing agents, with low incidences of adverse reactions in early trials.
• Imaging Performance: Reports suggest slightly superior imaging detail in specific applications, but these claims require validation in large-scale studies.

What Are the Market Trends and Drivers for Contrast Agents?

Market drivers include increasing medical imaging procedures driven by aging populations and rising disease prevalence (cardiovascular, cancer). Regulatory pressures encourage the development of lower-osmolar, safer contrast agents. The trend favors iso- and low-osmolar agents over high-osmolar products due to reduced incidences of nephrotoxicity and allergic reactions.

In the context of HYPAQUE-76, a competitive edge hinges on safety and imaging efficacy. The shift toward safer agents may facilitate market adoption if clinical results prove favorable.

What Is the Market Projection for HYPAQUE-76?

Given the current status—limited clinical data, absence of regulatory approval, and no significant market presence—HYPAQUE-76's market entry is projected for 2025 or later, assuming successful clinical trial completion and approval.

Estimates suggest that a new contrast agent could capture 1-3% of the global contrast media market within five years of launch, primarily targeting niche applications or regions with unmet needs. This implies potential revenues in the range of $50-150 million annually, assuming a conservative adoption rate.

Key factors influencing market projection include:

• Regulatory Approval Timeline: Accelerated pathways or delays affect market entry.
• Clinical Validation: Demonstrating superior safety or imaging performance enhances adoption.
• Pricing Strategy: Competitive pricing against established brands is critical for market penetration.
• Geographic Expansion: Approval in major markets like the U.S., EU, and Asia expands revenue potential.

How Does the Market Entry of HYPAQUE-76 Compare to Similar New Drugs?

Entry of new contrast agents generally follows a pattern:

Drug	Approval Year	Market Share (3 Years Post-Launch)	Key Differentiator
Iodixanol (Visipaque)	2001	4-7%	Iso-osmolar profile
Iopamidol (Niopam)	1987	5-8%	Widely used, cost-effective
Visipaque (iodixanol)	2001	3-6%	Reduced nephrotoxicity

HYPAQUE-76 may follow similar trajectories, with the main challenge being clinical differentiation and market acceptance.

What Are the Key Challenges and Opportunities?

Challenges:

• Limited clinical data delaying regulatory approval.
• Entry barriers due to dominance of established contrast agents.
• Cost pressures from healthcare providers demanding cost-effective solutions.
• Potential safety concerns if adverse reaction rates are higher than competitors.

Opportunities:

• Developing contrast agents with fewer adverse reactions.
• Moving into emerging markets with less competitive saturation.
• Leveraging advanced imaging technology to improve diagnostic outcomes.

Key Market Insights Summary

• HYPAQUE-76 is in early-phase clinical evaluation.
• The global contrast agent market is expected to grow at 4% CAGR through 2026.
• Entry barriers include established competitors and regulatory hurdles.
• Successful approval and differentiated clinical performance could yield limited but meaningful market share within five years of launch.
• Market size for new contrast agents could reach $150 million annually with strategic positioning.

Final Considerations for Stakeholders

Any investment or partnership decision should consider clinical trial timelines, regulatory pathways, and competitive landscape. Commercial success hinges on demonstrated safety and efficacy, targeted marketing, and strategic pricing.

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Key Takeaways

• HYPAQUE-76 remains in phase 2 trials, with no regulatory approval yet.
• The contrast media market is consolidating around low- and iso-osmolar agents.
• Market entry is expected around 2025, with modest initial market share.
• Differentiation based on safety and imaging quality is fundamental to competitive positioning.
• Long-term success depends on clinical results, regulatory approval, and strategic market access.

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FAQs

1. When is HYPAQUE-76 expected to receive regulatory approval?
Based on current clinical trial progress, approval could be anticipated around 2024-2025, assuming successful completion and regulatory review timelines.

2. How does HYPAQUE-76's safety profile compare to existing contrast agents?
Preliminary trials indicate similar adverse event rates to established agents, with no major safety concerns reported. Confirmatory data from larger trials is pending.

3. What are the main competitors of HYPAQUE-76?
Iodixanol (Visipaque), iohexol, iopamidol, and ioversol.

4. What regions are prioritized for market entry?
Initial focus likely includes the U.S., European Union, and select Asian markets with high imaging procedure volumes.

5. What strategies could enhance the market penetration of HYPAQUE-76 upon approval?
Differentiation through improved safety profile, targeted marketing to specialty imaging centers, and competitive pricing are crucial. Also, establishing clinical evidence supporting its advantages over competitors can broaden acceptance.

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References

[1] World Market Monitor. "Contrast Media Market Size & Forecast." 2021.