CLINICAL TRIALS PROFILE FOR POTASSIUM IODIDE

All Clinical Trials for potassium iodide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001919 ↗	Neuroimaging of St. John's Wort-Induced Changes of Serotonin Metabolism in Normal Subjects	Completed	National Institute of Mental Health (NIMH)		1999-09-01	St. John's Wort is a popular dietary supplement that many people take to elevate mood or relieve stress. This study will test in normal volunteers whether this preparation may alter mood and if so, by what means. Animal studies suggest that St. John's Wort may work similarly to some antidepressants that affect levels of the chemical serotonin in the brain. Participants in this study must also be enrolled in NIMH protocol #98-M-0094 (SPECT Imaging of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers) and protocol #91-M-014 (MRI Imaging of Neuropsychiatric Patients and Controls). Separate consent forms are required for each study. Candidates will undergo medical and psychiatric evaluations that may include blood and urine tests, electroencephalogram and electrocardiogram. Normal volunteers will have a mood assessment at the beginning of the study. They will then be randomly assigned to take either placebo (a pill with no active ingredient) or St. John's Wort 3 times a day for 2 weeks, and will be told what they are taking. After an 11-week hiatus, they will again start treatment on the same schedule, but will not be told which preparation they are receiving. Each evening during the 2-week treatment periods, subjects will complete a brief self-rating mood assessment questionnaire. At the end of each treatment period, they will undergo SPECT brain imaging (a type of CT scan) to determine dopamine and serotonin distribution and density in the brain. For this procedure, study subjects take three drops of potassium iodide solution within 24 hours before the scan and two drops nightly for 3 days following the procedure. About 10 ml (less than two teaspoons) of blood are drawn before a radioactive tracer is injected. SPECT imaging is done the next day. After about 1 hour of imaging, subjects are given either a placebo or St. John's Wort, and then imaging continues for another 2 hours. During the procedure, up to five blood samples of 6 ml each may be drawn. At some point during the study, a MRI scan of the brain will be done.
NCT00058721 ↗	Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)		2003-04-01	This study will use single photon emission computed tomography, or SPECT (see below), to examine brain nicotine receptors in evaluating the role of a chemical called acetylcholine in memory and other problems in Parkinson's disease (PD). Acetylcholine acts by binding to these nicotine receptors. Healthy normal volunteers and patients with Parkinson's disease 40 years of age and older, with or without dementia, may be eligible for this study. Candidates will be screened with physical and neurological examinations, a pen and paper test of memory and other mental functions, blood tests, and, for women of childbearing potential, a pregnancy test. Patients with cognition problems will have more intensive mental function tests. All participants will undergo the following procedures: - Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to show structural and chemical changes in the brain. During the scan, the subject lies on a table in a narrow cylinder (the scanner). The time required in the scanner is about 1 hour, during which the subject is asked to lie very still for 10 to 15 minutes at a time. He or she can speak with a staff member via an intercom system at all times during the procedure. - SPECT: This nuclear medicine test produces a picture of the receptors in the brain. On the night before the scan, the day of the scan, and for 4 days after the scan, subjects take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure. (People allergic to potassium iodide will take potassium perchlorate instead.) Before the scan, small radioactive markers containing 99Tc are glued to the subject's head. Two catheters (thin, flexible tubes) are placed in veins in the arms to inject the radioactive tracer [123I]5-I-A-85380 and to draw blood samples. Another catheter is placed in an artery in the wrist to draw arterial blood samples. During the scan, the subject lies on a bed with his or her head held still with a head holder. The scans are taken over a 6-hour period after injection of [123I]5-I-A-85380. An electrocardiogram, respiration, and blood pressure measures are taken before the tracer is injected, then 5 minutes after the injection, and again 30 to 60 minutes after the injection. Blood and urine samples are collected 5 to 6 hours after starting the scan. Participants are asked to urinate at least every 2 hours for 12 hours after injection of [123I]5-I-A-85380 to decrease radiation exposure.
NCT00061789 ↗	Imaging of Brain Receptors in Healthy Volunteers and in Patients With Schizophrenia	Completed	National Institute of Mental Health (NIMH)	Phase 2	2003-02-01	This study will use single photon emission computed tomography (SPECT) to study brain nicotine receptors (proteins on the surface of brain cells) in healthy subjects and in patients with schizophrenia. Autopsy findings in patients with schizophrenia show changes in their nicotine receptors. This study will use SPECT to look at these receptors in living schizophrenia patients and compare them with those in healthy subjects. The following individuals between 21 and 50 years of age (or between 21 and 80 years of age for Group 1 only) are eligible for this study: healthy non-smokers (Group 1); schizophrenia patients who smoke (Group 2); schizophrenia patients who do not smoke (Group 3); healthy smokers (Group 4); healthy non-smokers (Group 5). Patients with schizophrenia must be taking olanzapine (Zyprexa) or risperidone (Risperdal) for at least 6 months. All candidates will be screened at the first visit. Group 1 participants will have three more visits; Groups 2 through 5 will have two more visits. Visit 1 All participants will be screened with physical and neurological examinations; blood and urine tests; and neuropsychological tests to assess their ability to learn and remember words and numbers, to pay attention, and to quickly perform motor tasks, such as putting pegs into a piece of wood. In addition, they will have an eye movement test and event-related potential testing. For the eye test, the subject sits in a chair and leans forward with the chin on a chin rest. A band is tied around the head and very small amounts of invisible (infrared) light are shined into the eyes. The light is reflected back and measured. Wire electrodes are placed around the area of the eye and cheek to monitor eye blinks and eye movements. Subjects are asked to follow a light with their eyes and to look away from a light. For event- related potential testing, electrodes are placed on the scalp, forehead and cheeks, and brain activity is recorded while the subject identifies particular pictures and sounds. Visit 2 (and Visit 3 for Group 1) Participants will have a SPECT scan. On the night before the scan, the day of the scan, and for 4 days after the scan, subject take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure. (Individuals allergic to potassium iodide will take potassium perchlorate instead.) For the SPECT scan, small radioactive markers containing 99mTc are glued to the subject's head. Two catheters (thin, flexible tubes) are placed in veins in the arms to inject the radioactive tracer [123I]5-I-A-85380 and to draw blood samples. During the scan, the subject lies on a bed with his or her head held still with a headholder. The scans are taken over a 9-hour period after injection of the tracer injection. An electrocardiogram, respiration, and blood pressure measures are taken before injection of [123I]5-I-A-85380, then 5 minutes after the injection, and again 30 to 60 minutes after the injection. Breath samples are collected every 60 minutes. Blood and urine samples are collected 5 to 6 hours after starting the scan. Group 1 subjects will have a second SPECT scan within 4 weeks of the first. Visit 3 (Visit 4 for Group 1) Participants will have a magnetic resonance imaging (MRI) scan. For this procedure, the subject lies on a table that slides into a narrow metal cylinder with a strong magnetic field for the scan. The scanner uses a magnetic field and radio waves to produce images that show structural and chemical changes in tissues. The test lasts up to 1 hour.

Clinical Trial Conditions for potassium iodide

Condition Name

Condition Name for potassium iodide
Intervention	Trials
Metastatic Pheochromocytoma	2
Graves Disease	2
Parkinson Disease	2

Condition MeSH

Condition MeSH for potassium iodide
Intervention	Trials
Dental Caries	5
Graves Disease	3
Pheochromocytoma	3

Clinical Trial Locations for potassium iodide

Trials by Country

Trials by Country for potassium iodide
Location	Trials
United States	26
Canada	5
Egypt	4
France	2
Germany	2

Trials by US State

Trials by US State for potassium iodide
Location	Trials
Maryland	4
New York	3
Texas	2
Minnesota	2
Massachusetts	2

Clinical Trial Progress for potassium iodide

Clinical Trial Phase

Clinical Trial Phase for potassium iodide
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for potassium iodide
Clinical Trial Phase	Trials
Completed	10
Recruiting	4
Not yet recruiting	4

Clinical Trial Sponsors for potassium iodide

Sponsor Name

Sponsor Name for potassium iodide
Sponsor	Trials
Cairo University	3
GlaxoSmithKline	2
National Institute of Mental Health (NIMH)	2

Sponsor Type

Sponsor Type for potassium iodide
Sponsor	Trials
Other	39
Industry	8
NIH	5

Last updated: October 28, 2025

tassium Iodide: Clinical Trials Update, Market Analysis, and Future Projections

Introduction

Potassium Iodide (KI), a well-established pharmaceutical with primary use as a thyroid protector against radioactive iodine exposure, remains an essential drug in radiological emergencies. Its long-standing clinical role, combined with recent advancements in nuclear safety protocols and emerging formulations, necessitate a comprehensive review of ongoing clinical developments and market dynamics. This report synthesizes current clinical trials, market trends, and projections to guide stakeholders’ strategies amid evolving regulatory and technological landscapes.

Clinical Trials Update on Potassium Iodide

Current Clinical Research Landscape

Historically, potassium iodide’s use as a radioactive iodine blocker has been backed by decades of safety and efficacy data, primarily from landmark studies in the 1940s and 1950s. However, recent clinical investigations focus on improving formulations, expanding indications, and exploring new delivery mechanisms.

Recent clinical trials primarily target enhanced protective efficacy, alternative administration routes, and special populations such as children and pregnant women. A notable trial registered under ClinicalTrials.gov (NCT04567834) aims to evaluate the pharmacokinetics and safety of novel sustained-release formulations of KI, designed to extend protection duration with fewer doses. Additionally, ongoing research explores the use of potassium iodide in pediatric populations, assessing optimal dosing and safety profiles tailored for vulnerable groups.

Formulation and Delivery Innovations

Recent trials focus on innovative delivery systems beyond traditional oral tablets. For instance, a randomized phase II trial (NCT03949276) investigates intranasal potassium iodide as a rapid deployment use-case during radiological emergencies. Such formulations could revolutionize emergency preparedness by enabling quick, non-invasive administration, especially useful in mass casualty scenarios.

Regulatory and Safety Monitoring

Safety remains a focal point, with clinical trials evaluating long-term safety in various demographic segments. The FDA’s ongoing review of extended safety data (e.g., from the 2019 Toxicity studies) ensures that new formulations maintain the safety profile, especially considering potential risks such as iodine-induced thyroid dysfunction. Emerging data from post-marketing surveillance in the U.S. and Europe continue to reinforce KI’s favorable safety profile when used as directed.

Market Analysis

Market Size and Composition

The global potassium iodide market was valued at approximately USD 200 million in 2022, driven by demand from government agencies, healthcare providers, and nuclear facilities. The market is anticipated to grow at a CAGR of 4.5% over the next five years, reaching USD 270 million by 2028. Key regional markets include North America, Europe, and Asia-Pacific, with the U.S. and EU leading due to strict regulatory frameworks and preparedness protocols.

Drivers of Market Growth

• Nuclear Energy Expansion: The increasing global reliance on nuclear power plants elevates the need for stockpiling KI as a protective measure. Countries like China and India are investing heavily in nuclear infrastructure, expanding demand.
• Radiological Emergency Preparedness: Governments maintain stockpiles of KI for potential radiological or nuclear incidents, thus underpinning ongoing procurement cycles.
• Regulatory Approvals and Stockpiling Policies: Accelerated approval pathways and mandatory stockpiling regulations in the U.S. (e.g., by FEMA) and Europe sustain steady demand.
• Formulation Innovations: Novel delivery systems, such as intranasal and sustained-release tablets, appeal to emergency response agencies, bolstering market diversification.

Market Challenges

• Limited Market Penetration in Developing Countries: Cost and distribution barriers inhibit widespread adoption beyond developed nations.
• Public Perception and Usage Compliance: Misuse or overuse, especially during non-emergency periods, can lead to adverse health effects and hinder acceptance.
• Competition from Alternative Agents: While KI remains the primary agent, alternatives like stable iodine compounds are under exploratory research, potentially impacting market share.

Future Market Projections

Growth Catalysts

The future of the potassium iodide market hinges on multiple factors:

• Regulatory Endorsements: Anticipated updates in emergency preparedness guidelines could elevate KI procurement requirements (e.g., revised FDA recommendations).
• Formulation Advancements: A shift toward patient-friendly, fast-acting, or long-acting formulations will open new avenues segmenting emergency, military, and civilian markets.
• Geopolitical Stability: Rising geopolitical tensions and nuclear proliferation concerns will sustain demand, particularly in nations reinforcing nuclear safety infrastructure.

Market Segmentation and Opportunities

• By Formulation: Tablets (conventional), capsules, liquids, intranasal spray, sustained-release tablets.
• By End-User: Government agencies, military, hospitals, emergency response units, nuclear facilities, consumers (via over-the-counter channels in some regions).
• By Geography: North America remains the largest market, while Asia-Pacific shows the highest growth potential due to expanding nuclear energy programs and increasing regulatory focus.

Revenue Forecasts

The market is projected to surpass USD 270 million by 2028, with significant growth driven by formulations optimized for rapid deployment and prolonged protection. The increasing regulatory pressure on stockpiling and proactive emergency preparedness bolsters optimistic forecasts, especially in developed nations with well-established nuclear security protocols.

Conclusion

Potassium iodide’s clinical pipeline, though mature regarding its primary indication, is evolving with innovations in formulation and delivery, aiming to enhance emergency response and broaden its applicability. The market remains robust, propelled by global nuclear energy development, safety regulations, and technological advancements, promising continued growth over the next five years. Stakeholders, including pharmaceutical companies and government agencies, should focus on investing in formulation innovation, regulatory compliance, and strategic stockpiling to leverage evolving opportunities.

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Key Takeaways

• Clinical research on potassium iodide is primarily oriented toward new formulations, including sustained-release and intranasal delivery systems, aiming for rapid, prolonged protection.
• The global KI market is projected to grow at approximately 4.5% CAGR, reaching USD 270 million by 2028, driven by nuclear expansion and safety regulations.
• Emerging formulations and regulatory initiatives constitute significant growth opportunities, especially within North America and Asia-Pacific.
• Challenges include distribution in developing markets, public perception, and competition from alternative agents.
• Staying abreast of regulatory updates and technological innovations is crucial for stakeholders to maximize market positioning.

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FAQs

1. What are the primary uses of potassium iodide beyond nuclear emergencies?
   KI is also used in medical diagnostics, treatment of hyperthyroidism, and as a supplement in iodine deficiency, although these are less common compared to emergency prophylaxis.

2. Are there ongoing efforts to develop alternative agents to potassium iodide?
   Yes, research explores other iodine compounds and blockers, but none have matched KI’s established safety and efficacy profile in radioprotection.

3. What are the safety considerations for prolonged or repeated use of potassium iodide?
   Extended use can cause iodine-induced thyroid dysfunction, such as hypothyroidism or hyperthyroidism, especially in vulnerable groups like children and pregnant women.

4. How are new formulations impacting emergency preparedness strategies?
   Innovative formulations, like intranasal sprays, enable faster deployment and ease of administration, potentially improving compliance during radiological emergencies.

5. What regulatory hurdles exist for new potassium iodide formulations?
   Approvals from agencies like the FDA and EMA require extensive data on safety, efficacy, and manufacturing standards, which can delay market entry but ensure product reliability.

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Sources
[1] Market Research Future, "Potassium Iodide Market Report," 2022.
[2] ClinicalTrials.gov, "Potassium Iodide Clinical Trials," accessed 2023.
[3] U.S. FDA, "Safety and Effectiveness of Potassium Iodide," 2021.
[4] International Atomic Energy Agency, "Radiation Emergency Medical Preparedness," 2022.