CLINICAL TRIALS PROFILE FOR POTASSIUM ACETATE

505(b)(2) Clinical Trials for Potassium Acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04039828 ↗	Zinc Sulfate Acceptability	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	N/A	2019-09-09	Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months -

All Clinical Trials for Potassium Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118482 ↗	Clinical Trial for the Prevention of Vasovagal Syncope	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	2005-05-01	The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00118482 ↗	Clinical Trial for the Prevention of Vasovagal Syncope	Completed	University of Calgary	Phase 4	2005-05-01	The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	Eli Lilly and Company	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	National University Hospital, Singapore	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	Thrasher Research Fund	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	World Bank	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.

Clinical Trial Conditions for Potassium Acetate

Condition Name

Condition Name for Potassium Acetate
Intervention	Trials
Diabetes	2
Metabolome	1
PSA	1
Congestive Heart Failure	1

Condition MeSH

Condition MeSH for Potassium Acetate
Intervention	Trials
Diarrhea	2
Ketosis	2
Diabetic Ketoacidosis	2
Syncope, Vasovagal	1

Clinical Trial Locations for Potassium Acetate

Trials by Country

Trials by Country for Potassium Acetate
Location	Trials
United States	12
Canada	10
Bangladesh	3
Taiwan	2
Oman	1

Trials by US State

Trials by US State for Potassium Acetate
Location	Trials
Virginia	2
Massachusetts	2
Minnesota	1
Indiana	1
California	1

Clinical Trial Progress for Potassium Acetate

Clinical Trial Phase

Clinical Trial Phase for Potassium Acetate
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	5
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Potassium Acetate
Clinical Trial Phase	Trials
Completed	10
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for Potassium Acetate

Sponsor Name

Sponsor Name for Potassium Acetate
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	3
Hoosier Cancer Research Network	1
State University of New York at Buffalo	1

Sponsor Type

Sponsor Type for Potassium Acetate
Sponsor	Trials
Other	28
Industry	5
NIH	1

Clinical Trials Update, Market Analysis, and Prognosis for Potassium Acetate

Last updated: October 28, 2025

Introduction

Potassium Acetate (KCH₃COO) remains a critical pharmaceutical and industrial compound with diverse applications. Its significance spans from medical use as a potassium supplement to industrial roles in manufacturing, food processing, and chemical synthesis. This report provides a comprehensive update on the recent clinical trial landscape, market dynamics, and future projections for potassium acetate, aiming to inform stakeholders on its evolving profile within global health and industrial sectors.

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Clinical Trials Landscape for Potassium Acetate

Current Clinical Investigations

While potassium acetate's well-established role in electrolyte replenishment limits the volume of ongoing clinical trials generally associated with its generic form, recent research focus has shifted toward novel therapeutic applications and formulations involving potassium compounds. Notably, clinical trials exploring potassium acetate as an adjunct therapy for specific metabolic or electrolyte imbalance conditions are sparse but emerging.

The clinical research pipeline suggests concentrated activity in two primary areas:

• Electrolyte Repletion and Management: Ongoing studies assess optimized administration protocols for potassium acetate in critical care settings to prevent hypokalemia, especially in patients under diuretic therapy or with cardiac conditions. These trials aim to refine dosing strategies to mitigate risks such as hyperkalemia.

• Potential Neuroprotective Effects and Metabolic Benefits: Preliminary investigations explore potassium's role in neuronal function, with some trials examining potassium acetate's potential to modulate neural excitability and metabolic pathways, though these remain at early stages with limited published results.

Regulatory and Clinical Trial Trends

The FDA and EMA maintain a cautious stance on generic electrolyte preparations, emphasizing safety and efficacy. Notably, no recent high-profile phase III trials specifically targeting potassium acetate as a new therapeutic agent have been registered within major clinical trial registries (e.g., ClinicalTrials.gov, EU Clinical Trials).

Additionally, the repurposing of potassium acetate in experimental anti-inflammatory or immunomodulatory treatments remains speculative, with limited data substantiating such claims.

Challenges and Opportunities

• Limited Novel Indications: The lack of substantial clinical innovation directly linked to potassium acetate constrains its pipeline growth potential. The compound's longstanding generic status minimizes incentives for extensive clinical research outside established uses.

• Emerging Technologies: Advances in drug delivery systems (e.g., controlled-release formulations) and targeted therapies could potentially unlock niche clinical applications, but these are currently in preclinical phases.

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Market Analysis of Potassium Acetate

Global Market Overview

The global potassium acetate market was valued at approximately $100–120 million in 2022, reflecting its moderate but steady demand across multiple sectors. The primary drivers include healthcare needs for electrolyte replacement, food additive use, and industrial applications such as de-icing.

Key regional markets:

• North America: Dominates due to high healthcare spending, robust pharmaceutical manufacturing, and industrial infrastructure.

• Europe: Similar demand profile, with strict regulations fueling the search for high-purity potassium acetate sources.

• Asia-Pacific: Expected to witness the fastest CAGR (~4-6%), driven by expanding pharmaceutical industries and infrastructural development, notably in China and India.

Segmental Insights

• Pharmaceutical Sector: The largest consumer segment, accounting for approximately 50-55% of total demand. Potassium acetate's role as an electrolyte replenisher remains vital in hospitals and clinics.

• Industrial Applications: Involved in manufacturing processes like textile dyeing, printing, and as a chemical precursor, constituting about 25-30% of the market.

• Food Industry: Usage as a food additive (E524) accounts for roughly 15% but shows steady growth owing to increasing consumer health awareness and clean label trends.

Supply Chain and Price Trends

Major suppliers source potassium acetate predominantly via chemical synthesis from potassium hydroxide and acetic acid. Market prices have exhibited moderate fluctuations, influenced by raw material costs, regulatory frameworks, and environmental policies. Supply chain disruptions, notably amid global logistics constraints, temporarily impacted prices in 2021–2022, but stability has resumed.

Competitive Landscape

Leading companies include:

• Sigma-Aldrich (Merck Group): A prominent supplier with high-purity grades for pharmaceutical applications.
• American Elements: Focuses on specialized chemical formulations.
• AkzoNobel and BASF: Involved in industrial-grade potassium acetate production.

Emerging players and regional manufacturers are expanding capacity, leveraging economies of scale and regulatory compliance to increase market share.

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Future Market Projections

Growth Outlook (2023–2030)

The potassium acetate market is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next decade, driven by:

• Increased healthcare expenditure and rising incidence of electrolyte imbalances.
• Expansion in industrial applications, especially in emerging economies.
• Innovation in formulations and potential new therapeutic uses, although these remain limited and speculative at present.

Potential Catalysts

• Regulatory standardization and quality certifications could facilitate broader pharmaceutical adoption.
• Environmental regulations promoting the use of biodegradable and less toxic chemical alternatives may influence industrial demand.
• Emerging health challenges, such as COVID-19-related complications, could temporarily elevate electrolyte management needs, indirectly supporting potassium acetate utilization.

Risks and Limitations

• Market saturation in traditional applications may slow growth.
• Regulatory hurdles, especially safety assessments for novel uses.
• Competitive substitutes like potassium chloride, which often offer cost advantages.

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Summary and Key Takeaways

• Clinical development for potassium acetate remains focused on established uses, with limited scope for new indications. Ongoing trials aim to optimize safety, dosing, and administration protocols rather than discover novel therapeutic benefits.
• Market demand predominantly stems from healthcare and industrial sectors, with North America leading in consumption and Asia-Pacific showing significant future growth potential.
• Market stability depends on raw material costs, regulatory clarity, and advances in manufacturing, with industry players investing in high-purity, specialized formulations.
• Future growth prospects are moderate, with opportunities arising from technological innovations, regulatory harmonization, and expanding applications in emerging markets.

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Key Takeaways

• Potassium acetate's clinical trial activity is focused on optimizing its essential role in electrolyte management, with minimal evidence of emerging therapeutic indications.
• The market is mature, with predictable demand in healthcare, industrial, and food sectors, and a moderate CAGR estimated at 3-5% through 2030.
• Asia-Pacific represents a strategic growth frontier, driven by expanding industrial and healthcare infrastructure.
• Supply chain stability and regulatory compliance are critical to market sustainability, with potential impacts from raw material costs and environmental policies.
• Innovation in formulation and application could unlock niche markets, but mainstream growth will largely depend on established demand for electrolyte replenishment.

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Frequently Asked Questions

Q1: What are the primary medical uses of potassium acetate?
A: The main medical application is as an electrolyte supplement to correct hypokalemia, particularly in critical care and during diuretic therapy.

Q2: Are there any new clinical innovations involving potassium acetate?
A: Currently, no significant novel therapeutic indications are under active clinical development; research mainly focuses on dosing optimization and safety.

Q3: How does the supply chain influence the market dynamics of potassium acetate?
A: Raw material costs, manufacturing capacity, and regulatory standards influence pricing, availability, and quality, impacting overall supply stability.

Q4: What factors are expected to drive market growth in the next decade?
A: Increasing healthcare needs, industrial expansion, and technological improvements in formulation and production are key drivers.

Q5: What are the main competitive challenges faced by potassium acetate manufacturers?
A: Market saturation in traditional segments, price competition with substitutes (e.g., potassium chloride), and regulatory hurdles pose ongoing challenges.

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References

[1] Market Research Future, "Potassium Acetate Market Analysis & Forecast," 2022.
[2] GlobalData, "Electrolyte Imbalance Market & Clinical Trends," 2023.
[3] ClinicalTrials.gov, "Potassium Acetate Clinical Trials Registry," Accessed 2023.
[4] Industry Reports, "Industrial Applications of Potassium Acetate," 2022.