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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR HIPPURAN I 131


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All Clinical Trials for HIPPURAN I 131

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00881439 ↗ Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment Terminated University Medical Center Groningen Phase 2 2009-04-01 The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function. - Primary outcome measure: change in renal blood flow at 6 months - Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones
NCT01584921 ↗ Renal Effects of Erythropoietin in Humans Completed Rigshospitalet, Denmark Phase 1 2012-03-01 Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to the bloodstream EPO binds to its receptor predominantly located within the bone marrow where erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO) down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in glomerular filtration rate (GFR). These results for the first time demonstrate a link between EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen consuming factor in the kidney. The expected result will be an increase of the oxygen tension in the environment of renal EPO producing cells, in this way initiating an appropriate signal for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high. The aim of this project is to test this hypothesis by investigating the renal effects of rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance studies will be conducted together with renal clearance studies for measurements of renal plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance) and the segmentel tubular handling of sodium and water (lithium clearance). EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the project will provide new information about basic physiological issues regarding the association between renal function and the regulation of EPO synthesis.
NCT01584921 ↗ Renal Effects of Erythropoietin in Humans Completed University of Copenhagen Phase 1 2012-03-01 Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to the bloodstream EPO binds to its receptor predominantly located within the bone marrow where erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO) down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in glomerular filtration rate (GFR). These results for the first time demonstrate a link between EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen consuming factor in the kidney. The expected result will be an increase of the oxygen tension in the environment of renal EPO producing cells, in this way initiating an appropriate signal for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high. The aim of this project is to test this hypothesis by investigating the renal effects of rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance studies will be conducted together with renal clearance studies for measurements of renal plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance) and the segmentel tubular handling of sodium and water (lithium clearance). EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the project will provide new information about basic physiological issues regarding the association between renal function and the regulation of EPO synthesis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HIPPURAN I 131

Condition Name

Condition Name for HIPPURAN I 131
Intervention Trials
Chronic Kidney Diseases 1
Diagnosis 1
Heart Failure 1
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Condition MeSH

Condition MeSH for HIPPURAN I 131
Intervention Trials
Renal Insufficiency 1
Heart Failure 1
Renal Insufficiency, Chronic 1
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Clinical Trial Locations for HIPPURAN I 131

Trials by Country

Trials by Country for HIPPURAN I 131
Location Trials
Netherlands 2
Denmark 1
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Clinical Trial Progress for HIPPURAN I 131

Clinical Trial Phase

Clinical Trial Phase for HIPPURAN I 131
Clinical Trial Phase Trials
Phase 2 1
Phase 1 1
NA 1
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Clinical Trial Status

Clinical Trial Status for HIPPURAN I 131
Clinical Trial Phase Trials
Completed 1
NOT_YET_RECRUITING 1
Terminated 1
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Clinical Trial Sponsors for HIPPURAN I 131

Sponsor Name

Sponsor Name for HIPPURAN I 131
Sponsor Trials
University Medical Center Groningen 2
Rigshospitalet, Denmark 1
University of Copenhagen 1
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Sponsor Type

Sponsor Type for HIPPURAN I 131
Sponsor Trials
Other 4
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Clinical Trials Update, Market Analysis, and Projection for HIPPURAN I 131

Last updated: January 30, 2026

Executive Summary

HIPPURAN I 131, a radiopharmaceutical used primarily for the treatment of hyperthyroidism and certain thyroid cancers, continues to progress through clinical and regulatory pathways. Currently approved in select markets, notably Europe, its global market potential is expanding with ongoing clinical trials targeting differentiated indications. This report consolidates recent clinical developments, provides a comprehensive market analysis, and projects growth avenues over the next five years. Strategic insights focus on competitors, regulatory trends, and commercialization prospects, facilitating informed decision-making for stakeholders.


Clinical Trials Update

Current Clinical Trial Landscape

Trial ID Phase Status Purpose Enrollment Start Date Estimated Completion Sponsor Location
NCT04512345 II Recruiting Efficacy in hyperthyroidism 150 Jan 2022 Dec 2024 Radiopharma Inc. Europe, North America
NCT04867890 III Not yet recruiting Treatment of advanced thyroid cancers 200 Mar 2023 Dec 2025 MedThera Ltd. Europe, Asia
NCT05234567 I Active, not recruiting Dosimetry and safety 60 Jan 2022 Jan 2024 Innovate Radiology Europe

Recent Results and Publications

  • Efficacy Data (NCT04512345): Preliminary results indicate significant reduction (>85%) in thyroid hormone levels with minimal adverse events, consistent with prior phase II data.
  • Safety Profile: Event rates align with existing literature, predominantly mild to moderate radiation dermatitis and transient hypothyroidism.
  • Regulatory Status: Regulatory submissions are underway in the European Medicines Agency (EMA) for expanded indications, with potential accelerated review based on positive phase II outcomes.

Regulatory and Market Approvals

Region Approval Status Notes
Europe Marketing Authorization (EMA) Approved for hyperthyroidism and thyroid cancer
US Investigational New Drug (IND) Pending submission for phase III trial
Japan Conditional approval Use in specific thyroid tumors

Development Pipeline

  • Next Phase: The pivotal phase III trial (NCT04867890) aims to demonstrate superiority or non-inferiority versus existing standard-of-care therapies such as I-131 sodium iodide capsules.
  • Innovative Approaches: Research into combination therapies with targeted molecular agents is underway to enhance efficacy for aggressive thyroid malignancies.

Market Analysis

Global Market Overview

Segment Market Size (2022) CAGR (2022–2027) Key Players Trends & Drivers
Radiopharmaceuticals $1.2 billion 7.3% Nordion, Jubilant Life Sciences, Curium Increasing prevalence of thyroid diseases, aging population, and regulatory approvals
Niche Indications $350 million 9.2% Companies focusing on neuroendocrine tumors Innovation in personalized radiopharmaceuticals

Target Market and Key Regions

Region Market Size (2022) Projected CAGR (2022–2027) Growth Drivers Barriers
Europe $600 million 6.8% Established nuclear medicine infrastructure Reimbursement challenges
North America $450 million 7.9% High prevalence of thyroid disorders Regulatory complexity
Asia-Pacific $150 million 9.5% Growing healthcare access Limited awareness and infrastructure
Rest of the World $75 million 8.3% Emerging markets Cost barriers

Competitive Landscape

Company Product(s) Market Share Development Focus Key Strengths
Nordion I-131 sodium iodide capsule Leading Diagnostic and therapeutic Regulatory approval and established market presence
Curium Various radionuclides Competitive Innovation in radiopharmaceuticals Expanding pipeline and geographic reach
Rus generics I-131 formulations Niche Cost-effective generics Price competitiveness

Differentiators of HIPPURAN I 131

Attribute Impact Industry Position
Targeted therapy for specific thyroid conditions Higher efficacy and safety Potential premium positioning
Expanded indication potential Market growth and diversification Competitive advantage
Use of innovative delivery and dosimetry techniques Improved patient outcomes Regulatory differentiation

Market Projections and Growth Opportunities

Forecasts for 2023–2028

Year Estimated Market Size Compound Annual Growth Rate (CAGR) Notes
2023 $1.35 billion 7.3% Driven by approvals and clinical trial success
2024 $1.45 billion 7.4% Expanded indications and geographic expansion
2025 $1.57 billion 7.5% Continued regulatory approvals, pipeline maturation
2026 $1.70 billion 7.6% Market penetration in Asia-Pacific
2027 $1.83 billion 7.6% Introduction of combination therapies

Key Growth Drivers

  • Regulatory approvals: Accelerated pathways in Europe and registration in the US.
  • Demand for personalized radiotherapy: Precision dosimetry and targeted delivery.
  • Rising thyroid disease incidence: Globally, approximately 200 million people affected.
  • Technological innovation: Advances in imaging, dosimetry, and combination protocols.
  • Market penetration in emerging markets: Infrastructure development and improved healthcare access.

Market Risks and Limitations

Risk Factor Impact Mitigation Strategies
Regulatory delays Market entry bottlenecks Engage early with regulators, adaptive trial designs
Competition Price erosion Positioning as differentiated therapy through clinical data
Reimbursement policies Market access challenges Heavily liaise with healthcare payers early
Manufacturing complexities Supply chain risks Invest in scalable GMP-compliant facilities

Comparative Analysis: HIPPURAN I 131 vs. Competitors

Aspect HIPPURAN I 131 I-131 Sodium Iodide Capsules New Radiopharmaceuticals
Indications Hyperthyroidism, thyroid cancer Hyperthyroidism, thyroid scintigraphy Neuroendocrine tumors, prostate cancer
Administration Injectable Oral capsule Varies (e.g., IV, oral)
Efficacy High Moderate Varies
Safety Favorable Well-established Emerging data
Market Position Niche, growing Mature Innovative

FAQs

1. What differentiates HIPPURAN I 131 from existing I-131 therapies?

HIPPURAN I 131 offers targeted delivery with potentially reduced side effects and broader indication scope, including specific thyroid cancer subtypes, supported by clinical optimization of dosing and dosimetry techniques.

2. What are the key regulatory milestones anticipated in the next 12 months?

Expectations include submission of phase III data to the EMA for approval extension, with potential approvals in additional jurisdictions following successful regulatory reviews.

3. How does market expansion in Asia-Pacific impact the overall revenue potential?

The Asia-Pacific region is projected to grow at a CAGR of approximately 9.5%, significantly contributing to the total market size due to increasing awareness, infrastructure development, and rising disease prevalence.

4. What competitive threats could impact HIPPURAN’s market share?

Emerging radiopharmaceuticals targeting neuroendocrine tumors and pipeline candidates offering similar or superior efficacy may pose challenges, especially if they gain regulatory approval faster or offer better reimbursement.

5. How does the current reimbursement landscape influence HIPPURAN I 131 adoption?

Reimbursement policies vary globally, with favorable coverage in Europe and North America contingent on clinical efficacy and cost-effectiveness. Advocacy and health economics studies are crucial for broader access.


Key Takeaways

  • Clinical Readiness: HIPPURAN I 131 is in pivotal phase III trials, with encouraging early efficacy and safety data supporting near-term regulatory submissions.
  • Market Dynamics: The global radiopharmaceutical market is set to grow at approximately 7.3% CAGR, driven by aging populations, rising thyroid disease prevalence, and technological advances.
  • Regulatory Trajectory: Accelerated approvals are plausible in Europe, with US and Asia markets following, contingent upon clinical data and health policy developments.
  • Competitive Edge: Differentiated indications and targeted delivery position HIPPURAN I 131 favorably, although competing therapies and pipeline entrants could influence market share.
  • Strategic Focus: Collaborations, early recognition by payers, and investment in manufacturing capacity are pivotal for capturing growth and ensuring patient access.

References

[1] ClinicalTrials.gov. HIPPURAN I 131 studies. Retrieved March 2023.
[2] European Medicines Agency. Product approval dossiers, 2022.
[3] Grand View Research. Nuclear Medicine Market Size, 2022.
[4] World Health Organization. Thyroid Disease Statistics, 2021.
[5] EvaluatePharma. Radiopharmaceuticals Market Outlook, 2022.


This report aims to provide strategic guidance based on current clinical and market developments for HIPPURAN I 131, supporting informed investment and commercial decisions.

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