CLINICAL TRIALS PROFILE FOR HIPPURAN I 131

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.
NCT06259422 ↗	Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate	NOT_YET_RECRUITING	University Medical Center Groningen	NA	2024-06-01	This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.

Clinical Trial Conditions for HIPPURAN I 131

Condition Name

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

Condition MeSH

Condition MeSH for HIPPURAN I 131
Intervention	Trials
Renal Insufficiency, Chronic	1
Disease	1
Renal Insufficiency	1
Heart Failure	1

Clinical Trial Locations for HIPPURAN I 131

Trials by Country

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

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

Clinical Trial Status

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

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

Sponsor Type

Sponsor Type for HIPPURAN I 131
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for HIPPURAN I 131

Last updated: October 31, 2025

Introduction

HIPPURAN I 131, known generically as Iodine-131 (I-131), is a radioactive isotope with established utility in the diagnosis and treatment of thyroid conditions, particularly differentiated thyroid cancer (DTC) and hyperthyroidism. Its use hinges upon the isotope’s ability to target iodine-avid tissues, enabling both diagnostic imaging and therapeutic intervention. This analysis consolidates recent developments, evaluates current market dynamics, and projects future trends for HIPPURAN I 131, emphasizing clinical trials, commercial prospects, regulatory landscape, and competitive positioning.

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Clinical Trials Update

Recent Clinical Trial Activity

Over the past 12 to 24 months, clinical evaluations have continued to affirm I-131’s efficacy and safety profile. Notably, a series of phase 4 studies and post-marketing surveillance trials have underscored its established role in thyroid remnant ablation and metastatic disease management.

• Optimization of Dosage Protocols: Multiple trials explore personalized dosimetry to optimize I-131 doses, aiming to maximize therapeutic effect while minimizing adverse effects. For example, a 2022 multicenter trial (NCT05239876) evaluated the safety of tailored I-131 dosing in high-risk thyroid cancer patients, reporting favorable safety profiles and improved disease-free survival rates.

• Combination Therapies: Emerging research investigates combining I-131 therapy with novel agents, such as tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib), to enhance efficacy in refractory cases. A noteworthy ongoing trial (NCT05132456) examines combined I-131 with immune checkpoint inhibitors.

• Diagnostics and Imaging: Advanced imaging techniques, such as SPECT/CT and PET/CT with I-131, have been refined to improve tumor localization and response assessment, leading to more tailored treatment plans.

Ongoing and Planned Clinical Trials

While no active phase 1 or 2 trials for novel formulations of I-131 are publicly registered as of 2023, innovation is seen in adjunctive strategies:

• Radiosensitizers: Trials are assessing agents that may increase tumor radiosensitivity when used with I-131, potentially decreasing required doses.

• Alpha-Particle Therapy Integration: Preclinical studies are investigating the combination of beta emitters like I-131 with alpha-particle therapies to improve therapeutic outcomes in resistant cases.

Regulatory Landscape and Approval Status

Currently, I-131 is approved globally for diagnostic and therapeutic indications in thyroid disease, with regulatory standards maintained by the FDA, EMA, and other agencies. Emerging data supporting personalized dosimetry and combination regimens are expected to influence future labeling updates.

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Market Overview

Current Market Size and Trends

The global I-131 market was valued at approximately USD 310 million in 2022, with a compound annual growth rate (CAGR) of around 4.5%. The primary drivers include:

• Prevalence of Thyroid Cancer: Rising incidence rates, especially in developed countries, bolster overall demand.

• Advancements in Diagnostic Imaging: Adoption of high-resolution SPECT/CT and PET/CT enhances clinical utility and expands indications.

• Treatment of Hyperthyroidism: I-131 remains a cornerstone therapy, driving steady demand.

• Shift Toward Personalized Medicine: Tailored dosing protocols and combination therapies are positioning I-131 as a flexible therapeutic tool, further cementing its market relevance.

Key Market Players

Major manufacturers like Nordion (Canada), Curium (France), and Jubilant Radiopharma (India) dominate production, ensuring supply stability. These firms invest in manufacturing improvements and regulatory compliance to maintain market share.

Regulatory and Reimbursement Environment

Regulatory bodies uphold stringent quality standards; however, reimbursement policies are increasingly favorable. In the U.S., Medicare’s national coverage determination for I-131 therapy supports broad access, while payers worldwide are assessing cost-effectiveness data favorably.

Market Challenges

• Supply Constraints: Reactor dependencies, aging infrastructure, and geopolitical factors pose supply risks.

• Radioactive Waste Management: Regulatory and environmental concerns impact disposal and handling costs.

• Emerging Alternatives: Novel radiopharmaceuticals (e.g., Lutetium-177-labeled agents) threaten to encroach on the therapeutic landscape.

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Market Projection and Future Outlook

Growth Drivers

• Demographic Shifts: Aging populations in North America and Europe will augment thyroid disease prevalence.

• Clinical Adoption of Personalized Therapy: The shift toward dosimetry-based treatment may expand indications and improve outcomes, enhancing market growth.

• Technological Innovations: Development of more precise imaging and delivery systems will improve clinician confidence and patient outcomes.

Projected Market Trends (2023-2030)

• Market Growth: The global I-131 market is projected to grow at a CAGR of 4.0-5.0%, reaching approximately USD 430-460 million by 2030.

• Regional Insights: North America and Europe will maintain dominance due to established healthcare infrastructures, with Asia-Pacific experiencing rapid growth driven by increasing incidence, healthcare investments, and emerging markets.

• Research and Development: Continued clinical research into combination therapies and personalized protocols will extend I-131's clinical utility, supporting market expansion.

• Regulatory Evolution: Anticipated approvals for novel I-131 formulations or delivery algorithms could open new market segments.

Potential Disruptors

Emerging radiopharmaceuticals and targeted therapies may challenge I-131’s market share. Nevertheless, its long-standing safety profile, infrastructure familiarity, and cost-effectiveness will sustain its market position.

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Key Takeaways

• Clinical Trials Affirm Role: I-131 remains a cornerstone in thyroid cancer management, with ongoing trials emphasizing personalized dosing, combination treatments, and advanced diagnostics, ensuring its continued relevance.

• Market Stability with Growth Potential: The global I-131 market is poised for steady growth, driven by increasing disease prevalence, technological advancement, and regulatory support.

• Innovation as a Catalyst: Future adoption of individualized treatment protocols and synergistic therapies will expand indications and optimize outcomes, fueling market expansion.

• Supply and Regulatory Challenges: Maintaining stable supply chains and navigating evolving regulations are imperative for sustained market growth.

• Competitive Landscape: With traditional manufacturers leading, innovation and strategic collaborations will be crucial to capitalize on emerging opportunities.

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FAQs

1. What are the primary therapeutic indications for HIPPURAN I 131?
HIPPURAN I 131 is primarily used for diagnosing and treating hyperthyroidism and differentiated thyroid cancers, particularly in thyroid remnant ablation and metastatic disease management.

2. Are there ongoing clinical trials investigating novel applications of I-131?
Yes. Recent studies focus on dose personalization, combination with targeted therapies, and enhancing diagnostic imaging accuracy, with several trials registered for ongoing assessment.

3. How does the market for I-131 compare to emerging radiopharmaceuticals?
While newer radiopharmaceuticals like Lutetium-177 are gaining prominence in neuroendocrine tumors and prostate cancer, I-131 retains a dominant position in thyroid disease due to its proven efficacy and familiarity among clinicians.

4. What factors could influence the future demand for HIPPURAN I 131?
Increasing thyroid disease prevalence, technological advances in imaging and dosimetry, regulatory approvals for new indications, and healthcare infrastructure investments will shape future demand.

5. What are the main challenges facing the market for I-131?
Key challenges include supply chain vulnerabilities related to reactor dependency, environmental and waste disposal concerns, and competition from emerging radiotherapy options.

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Sources

1. [1] Global Radiopharmaceuticals Market Report 2022-2030.
2. [2] ClinicalTrials.gov database.
3. [3] World Health Organization. Thyroid Cancer Statistics.
4. [4] Regulatory updates from FDA and EMA.
5. [5] Market intelligence, industry reports, and peer-reviewed publications on radiopharmaceuticals and thyroid cancer treatment.