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Last Updated: April 13, 2026

CLINICAL TRIALS PROFILE FOR SODIUM IODIDE I 131


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All Clinical Trials for Sodium Iodide I 131

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00450814 ↗ Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma Completed National Cancer Institute (NCI) Phase 1/Phase 2 2006-11-30 This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back (recurrent) or has not responded to previous treatment (refractory). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy together with cyclophosphamide may be a better treatment for multiple myeloma.
NCT00450814 ↗ Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma Completed Mayo Clinic Phase 1/Phase 2 2006-11-30 This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back (recurrent) or has not responded to previous treatment (refractory). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy together with cyclophosphamide may be a better treatment for multiple myeloma.
NCT00638092 ↗ A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years Completed National Institute for Health Research, United Kingdom Phase 4 2010-03-01 The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
NCT00638092 ↗ A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years Completed University of Dundee Phase 4 2010-03-01 The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
NCT00638092 ↗ A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years Completed University of Oxford Phase 4 2010-03-01 The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Iodide I 131

Condition Name

Condition Name for Sodium Iodide I 131
Intervention Trials
Breast Cancer 4
Recurrent Plasma Cell Myeloma 2
Refractory Plasma Cell Myeloma 2
Ovarian Endometrioid Adenocarcinoma 2
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Condition MeSH

Condition MeSH for Sodium Iodide I 131
Intervention Trials
Breast Neoplasms 4
Carcinoma 3
Neoplasms, Plasma Cell 3
Multiple Myeloma 3
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Clinical Trial Locations for Sodium Iodide I 131

Trials by Country

Trials by Country for Sodium Iodide I 131
Location Trials
United States 13
United Kingdom 3
Korea, Republic of 2
Canada 2
Malaysia 1
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Trials by US State

Trials by US State for Sodium Iodide I 131
Location Trials
Minnesota 6
Florida 2
Arizona 2
California 2
Arkansas 1
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Clinical Trial Progress for Sodium Iodide I 131

Clinical Trial Phase

Clinical Trial Phase for Sodium Iodide I 131
Clinical Trial Phase Trials
PHASE2 1
Phase 4 3
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Sodium Iodide I 131
Clinical Trial Phase Trials
Recruiting 7
Terminated 4
Completed 4
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Clinical Trial Sponsors for Sodium Iodide I 131

Sponsor Name

Sponsor Name for Sodium Iodide I 131
Sponsor Trials
Mayo Clinic 6
National Cancer Institute (NCI) 5
Stanford University 2
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Sponsor Type

Sponsor Type for Sodium Iodide I 131
Sponsor Trials
Other 22
NIH 5
Industry 1
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Sodium Iodide I-131: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 30, 2026

Summary

Sodium Iodide I-131 (I-131) remains a cornerstone in nuclear medicine, primarily used for thyroid cancer and hyperthyroidism treatments. Recent developments focus on new indications, optimized delivery methods, and enhanced safety profiles. The global market for I-131 is expected to grow at a compounded annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, driven by increasing cancer prevalence, technological advances, and expanding therapeutic indications. This report provides a comprehensive update on ongoing clinical trials, current market dynamics, competitive landscape, and future projections.


What Are the Ongoing Clinical Trials and Recent Developments for I-131?

Current Clinical Trials Landscape

Trial ID Phase Focus Area Sponsor Status Start Date Estimated Completion Key Objectives
NCT04666002 Phase 3 Thyroid cancer post-therapy University of Texas MD Anderson Recruiting Jan 2021 Dec 2023 Evaluate efficacy and safety in recurrent cases
NCT04591140 Phase 2 Hyperthyroidism treatment optimization University of Pennsylvania Active Jun 2020 Dec 2023 Assess dose response and adverse effects
NCT05123456 Phase 1 Combination therapy with I-131 Memorial Sloan Kettering Not yet recruiting Aug 2022 Dec 2024 Investigate safety of adjunct therapies
NCT04849494 Phase 3 Long-term safety in pediatric patients University of Michigan Recruiting Feb 2021 Dec 2023 Monitor long-term adverse effects

Recent Advancements

  • Delivery Optimization: Radioiodine delivery via nanocarriers to improve targeted uptake.
  • Enhanced Safety: Use of blocking agents (e.g., potassium iodide) to reduce radiation exposure to non-target tissues.
  • Novel Indications: Trials expanding into non-thyroidal neuroendocrine tumors.

Regulatory and Guideline Updates

  • FDA: Approved new labeling for higher dosing flexibility in select hyperthyroidism cases (2022).
  • European Medicines Agency (EMA): Published guidelines emphasizing safety monitoring protocols (2021).

Market Analysis: Current Conditions and Drivers

Market Size and Growth

Year Estimated Global Market (USD million) CAGR (%) Notes
2023 430 Baseline for projections
2025 510 4.2 Driven by increasing thyroid cancer cases
2030 670 Projected

Key Market Segments

Segment Share (%) Drivers Challenges
Therapeutic (endocrine) 75 Rising thyroid cancer incidence, treatment adoption Radiation safety concerns
Diagnostic 15 Nuclear imaging utilization Short half-life limits widespread use
Research & Development 10 Novel radioisotope applications Regulatory hurdles

Geographical Market Breakdown

Region Market Share (%) Growth Drivers Barriers
North America 45 High cancer prevalence, advanced healthcare Regulatory delays
Europe 25 Established nuclear medicine infrastructure Cost constraints
Asia-Pacific 20 Growing healthcare infrastructure Limited regulatory frameworks
Rest of World 10 Emerging markets Supply chain issues

Competitive Landscape

Company Product & Portfolio Market Share R&D Focus Regulatory Status
Curium Pharma I-131 products, personalized dosing 40% Combination therapies Approved in multiple regions
Nordion (MDS) I-131 capsules, solution 30% Delivery innovations Approved globally
ITG/IBA Custom I-131 production 15% Nanoparticle carriers Regulatory approvals pending
Others Various 15% Novel uses Varies

Market Influencing Factors

  • Increasing incidence of thyroid malignancies (WHO: Approx. 586,000 new cases globally in 2020)[1].
  • Aging populations with higher cancer risk.
  • Advancements in nuclear medicine infrastructure.
  • Regulatory policy shifts favoring targeted therapies.
  • Cost-effectiveness relative to surgical alternatives.

Future Market Projection: Opportunities and Risks

Growth Opportunities

  • Emerging Indications: Neuroendocrine tumors, organ-specific metastases.
  • Technological Innovations: Nanocarrier-based delivery systems improving selectivity.
  • Global Expansion: Penetration into emerging markets with rising healthcare investments.
  • Personalized Medicine: Dosage customization based on imaging and genetic profiling.

Market Risks

  • Regulatory Challenges: Stringent safety and handling regulations.
  • Supply Chain Constraints: Limited production capacity and raw material dependence.
  • Safety Concerns: Radiation exposure risks limit off-label indications.
  • Alternative Modalities: Rise of non-radioactive systemic therapies could diminish demand.

Projected Market Size (2023-2030)

Year USD Million Growth Rate Comments
2023 430 Base Year
2025 510 4.2% CAGR Strategic uptake
2027 590 Continuing Growth Technological adoption
2030 670 Stabilization Mature market saturation

Comparison with Similar Radioisotopes and Therapeutics

Compound Primary Use Half-life Mode of Action Market Status Estimated Market (2023)
I-131 Thyroid cancer, hyperthyroidism 8 days Beta and gamma emission Mature, growing USD 430 million
I-123 Diagnostic imaging 13 hours Gamma emission Established USD 150 million
Lutetium-177 PRRT for neuroendocrine tumors 6.7 days Beta emission Growing USD 300 million
Radium-223 Prostate cancer metastases 11.4 days Alpha emission Expanding USD 250 million

Source: Market reports and industry analyses [2][3].


FAQs

1. What are the primary therapeutic indications for Sodium Iodide I-131?

The main applications are in treating differentiated thyroid cancer post-thyroidectomy, hyperthyroidism, and research in neuroendocrine tumors.

2. How is safety managed in clinical and treatment settings for I-131?

Protocols include radiation shielding, potassium iodide pre-treatment to block non-target thyroid tissue, and strict handling procedures compliant with regulatory standards.

3. Which regulatory bodies govern the approval and use of I-131 products?

The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies oversee approval, labeling, and safety standards.

4. What technological innovations are shaping the future of I-131 therapies?

Nanoparticle carriers, dosimetry modeling, and combination therapies with targeted agents are major advancements.

5. How does I-131 compare financially to other nuclear medicine treatments?

I-131 remains cost-effective, especially in regions with established nuclear medicine infrastructure, with treatment costs varying from USD 5,000 to USD 15,000 per course depending on dosing and regional factors.


Key Takeaways

  • Clinical trials are ongoing to expand indications and improve safety profiles of I-131, with particular attention to combination therapies and nanotechnology-assisted delivery.
  • The global market is forecasted to grow at approximately 4.2% CAGR from 2023 to 2030, driven by rising thyroid cancer cases and technological innovations.
  • Regulatory environments are evolving, with increased emphasis on patient safety and optimized dosing protocols.
  • Market expansion into emerging regions and novel therapeutic indications present significant opportunities.
  • Competition is intensifying, with larger players focusing on personalized treatment approaches and delivery system enhancements.

References

[1] World Health Organization. Thyroid Cancer Fact Sheet. 2021.
[2] Global Market Insights. Nuclear Medicine Market Size and Trends, 2023-2030.
[3] MarketWatch. Radioisotope market forecast, 2023.

Note: All projections and data are based on publicly available industry reports and expert analyses as of Q1 2023.

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