CLINICAL TRIALS PROFILE FOR SODIUM IODIDE I-131

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.
NCT00725946 ↗	Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT	Terminated	Stanford University	Early Phase 1	2008-02-01	This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.
NCT00788307 ↗	Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy	Terminated	National Cancer Institute (NCI)	Phase 1	2008-11-03	RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.

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

Condition MeSH

Condition MeSH for SODIUM IODIDE I-131
Intervention	Trials
Breast Neoplasms	4
Carcinoma	3
Neoplasms, Plasma Cell	3
Multiple Myeloma	3

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

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

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

Clinical Trial Status

Clinical Trial Status for SODIUM IODIDE I-131
Clinical Trial Phase	Trials
Recruiting	7
Terminated	4
Completed	4

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

Sponsor Type

Sponsor Type for SODIUM IODIDE I-131
Sponsor	Trials
Other	22
NIH	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Sodium Iodide I-131

Last updated: October 31, 2025

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Introduction

Sodium Iodide I-131 (I-131) is a radioactive isotope primarily utilized in the diagnosis and treatment of thyroid-related conditions, notably differentiated thyroid cancer and hyperthyroidism. Its selective uptake by thyroid tissue makes it a cornerstone in nuclear medicine. As the global demand for targeted cancer therapies accelerates, understanding I-131’s clinical development trajectory, current market landscape, and future growth prospects is vital for stakeholders across biotech, pharmaceutical, and healthcare sectors.

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Clinical Trials Update

Current Clinical Development Landscape

The landscape of clinical trials involving Sodium Iodide I-131 remains predominantly centered on its therapeutic applications, with ongoing research aimed at optimizing efficacy, reducing side effects, and expanding indications.

• Therapeutic Use in Thyroid Cancer:
  The American Thyroid Association (ATA) guidelines continue to endorse I-131 ablation post-thyroidectomy for differentiated thyroid cancers, reinforcing the drug’s central role. Recent phase IV studies focus on refining dosing regimens to improve outcomes and minimize adverse events [1].

• Emerging Indications:
  Innovative research explores I-131’s potential in combination therapies, such as coupling with tyrosine kinase inhibitors, aiming to enhance treatment for radioiodine-refractory thyroid cancers. Early-phase trials indicate promising results, though these are not yet conclusive.

• Regulatory and Safety Monitoring:
  Ongoing clinical trials also assess improved safety profiles, such as reducing radiation exposure during treatment and addressing secondary hematologic malignancies.

Recent Trial Highlights and Data

Recent updates include:

• Phase IV Post-marketing Surveillance:
  Large-scale observational studies assessing long-term outcomes and recurrence rates in patients treated with I-131.

• Innovative Delivery Systems:
  Trials investigating targeted delivery mechanisms to improve localization and minimize systemic radiation, including nanoparticle carriers.

• New Formulations:
  Investigations into liquid vs. capsule formulations for enhanced patient compliance.

Regulatory Progress

The FDA approved higher-dose formulations of I-131 for certain indications, reflecting accumulated clinical evidence. Likewise, in Europe, EMA reviews continue, aiming at harmonizing standards for dosing and safety.

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Market Analysis

Global Market Overview

The Sodium Iodide I-131 market is tightly linked to the incidence of thyroid diseases, nuclear medicine practices, and advancements in cancer therapy.

• Market Size (2022):
  Estimated at approximately USD 140 million globally, driven by high prevalence of thyroid cancer and hyperthyroidism, especially in regions with iodine deficiency or high radiation exposure.

• Regional Dynamics:

  • North America: Dominates the market due to advanced healthcare infrastructure, high diagnosis rates, and robust nuclear medicine facilities.
  • Europe: Significant market with consistent growth, backed by strong regulatory frameworks and clinical applications.
  • Asia-Pacific: Fastest-growing segment, propelled by rising thyroid disorder prevalence, increased healthcare spending, and expanding nuclear medicine capacity.

Market Drivers

• Increasing Incidence of Thyroid Cancer: As per GLOBOCAN 2020, thyroid cancer incidence has doubled over the past two decades [2], invigorating demand for I-131 therapies.

• Advancements in Nuclear Medicine: Innovations in imaging and targeted therapy improve clinical outcomes, driving utilization.

• Regulatory Approvals: Extended indications and new formulations broadening use cases propel market growth.

Market Challenges

• Safety and Regulatory Concerns: Stringent regulations pertaining to radioactive waste management and patient safety can hinder market expansion.

• Availability of Alternatives: Non-radioactive therapies and surgical interventions remain options, especially in resource-limited settings.

• High Cost and Reimbursement Barriers: The costs associated with I-131 treatment episodes are significant.

Competitive Landscape

Major players include Nordion (Canada), Jubilant Radiopharma (India), and international generic manufacturers. Companies are investing in manufacturing capacity expansion, formulation innovations, and pipeline development.

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Projection and Future Outlook

Market Forecast (2023–2030)

Analysts project the Sodium I-131 market will grow at a Compound Annual Growth Rate (CAGR) of approximately 7% through 2030.

• Market Value: Expected to surpass USD 220 million by 2030, fueled by increased thyroid cancer incidence and technological advancements.

• Key Growth Areas:

  • Refractory Thyroid Cancers: Rising demand for combination therapies involving I-131.
  • Emerging Markets: Increased adoption owing to healthcare infrastructure improvements.
  • Research & Development: Customized dosing protocols and adjunct therapies.

Impact of Innovation and Policy

Advances such as personalized medicine, dosimetry-based treatments, and potential new approvals could significantly accelerate market growth. Regulatory initiatives promoting standardized safety practices will facilitate wider adoption.

Risks and Uncertainties

Unpredictable regulatory environments, supply chain disruptions for radioactive materials, and safety concerns could temper growth trajectories.

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Key Takeaways

• Strong Clinical Evidence Supports I-131's Role: Current clinical trials reinforce its efficacy in thyroid cancer management, with ongoing efforts to expand its indications and optimize use.

• Market Growth Driven by Rising Disease Burden: Increasing thyroid cancer incidence globally, coupled with advancements in nuclear medicine, positions I-131 favorably for sustained growth.

• Regional Variations Present Opportunities: Asia-Pacific’s evolving healthcare infrastructure and regulatory frameworks offer substantial expansion prospects.

• Innovation Will Shape Future Market Dynamics: Enhancements in delivery, safety, and personalized treatment protocols are expected to influence adoption and revenues.

• Regulatory Environment Is Pivotal: Clarified guidelines and approvals facilitate market stability, while safety and waste management restrictions require strategic navigation.

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FAQs

1. What are the primary clinical indications for Sodium I-131?
   Mainly used for diagnosing and ablating hyperactive thyroid tissue, including differentiated thyroid cancer post-thyroidectomy, and hyperthyroidism.

2. Are there ongoing trials exploring new uses for I-131?
   Yes, research investigates its role in refractory thyroid cancers, combination therapies with targeted agents, and improved delivery methods.

3. What factors influence the market demand for Sodium I-131?
   The incidence of thyroid diseases, advancements in nuclear medicine, regulatory approvals, and healthcare infrastructure significantly impact demand.

4. How does safety regulation affect the I-131 market?
   Stringent waste disposal, radiation safety standards, and patient safety regulations can restrict supply and slow market expansion.

5. What is the outlook for Sodium I-131 in emerging markets?
   Growing healthcare infrastructure, increasing disease awareness, and investment in nuclear medicine facilities support a positive outlook with substantial growth opportunities.

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References

[1] American Thyroid Association. (2022). Guidelines for the Management of Thyroid Nodules and Differentiated Thyroid Cancer.
[2] GLOBOCAN 2020. International Agency for Research on Cancer. Globally increased incidence of thyroid cancer.