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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR POTASSIUM ACETATE


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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 - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Potassium Acetate

Condition Name

Condition Name for Potassium Acetate
Intervention Trials
Diabetes 2
Diarrhoea 1
PSA 1
Kidney Failure 1
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Condition MeSH

Condition MeSH for Potassium Acetate
Intervention Trials
Ketosis 2
Diabetic Ketoacidosis 2
Diarrhea 2
Calculi 1
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Clinical Trial Locations for Potassium Acetate

Trials by Country

Trials by Country for Potassium Acetate
Location Trials
United States 12
Canada 10
Bangladesh 3
Czechia 1
Egypt 1
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Trials by US State

Trials by US State for Potassium Acetate
Location Trials
Virginia 2
Massachusetts 2
New York 1
Wisconsin 1
Pennsylvania 1
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Clinical Trial Progress for Potassium Acetate

Clinical Trial Phase

Clinical Trial Phase for Potassium Acetate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Potassium Acetate
Clinical Trial Phase Trials
Completed 10
Recruiting 3
Unknown status 2
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Clinical Trial Sponsors for Potassium Acetate

Sponsor Name

Sponsor Name for Potassium Acetate
Sponsor Trials
International Centre for Diarrhoeal Disease Research, Bangladesh 3
World Bank 1
Soll Eye 1
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Sponsor Type

Sponsor Type for Potassium Acetate
Sponsor Trials
Other 26
Industry 5
NIH 1
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Potassium Acetate: Clinical, Market, and Projection Analysis

Introduction

Potassium acetate is a versatile compound used in various industries, including pharmaceuticals, food, and de-icing. This article will delve into the clinical aspects, market analysis, and future projections of potassium acetate.

Clinical Use and Safety

Pharmaceutical Applications

Potassium acetate is used in the pharmaceutical industry as an ingredient in certain medications. It is particularly notable for its use in intravenous solutions to treat or prevent potassium deficiency (hypokalemia)[1].

Safety and Efficacy

  • Pregnancy and Lactation: There are no animal reproduction studies on potassium acetate, and it is not known whether it can cause fetal harm. It should be used in pregnant women only if clearly needed[1].
  • Pediatric Use: The safety and effectiveness of potassium acetate have been established in pediatric patients[1].
  • Geriatric Use: Elderly patients should be treated cautiously, starting with lower doses due to potential decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy[1].

Market Analysis

Global Market Size and Growth

The global potassium acetate market is projected to grow from $191 million in 2024 to $226.8 million by 2030, at a Compound Annual Growth Rate (CAGR) of 2.9% during the forecast period[2][3].

Market Segmentation

  • By Type: The market is segmented into Food Grade, Pharmaceutical Grade, and Industrial Grade. The Food Grade segment accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth[3].
  • By Application: Key applications include Industrial, Pharma & Food, Deicing, and others. The Industrial segment is expected to expand significantly throughout the forecast period[2][3].

Key Players

Major companies in the potassium acetate market include Niacet, Clariant, Cryotech, Hawkins, Nachurs Alpine Solutions, Daito Chemical, Lancashire Chemicals, Alkem, and several others. These companies are focusing on strategy building and expanding their product portfolios to strengthen their market presence[2][3].

Regional Market Insights

  • North America: This region holds a large market share due to the significant engagement of pharmaceutical companies in research and development[5].
  • Europe: The European market is expected to grow driven by the rising demand for food additives and pharmaceuticals[5].
  • Asia-Pacific: This region is growing due to increased industrial activity and agricultural applications[5].

Drivers and Trends

Growing Demand in Food and Beverage

The increasing demand for potassium acetate in the food and beverage industry, particularly as a pH stabilizer and preservative, is a significant driver of market growth[5].

Pharmaceutical Sector

Its utilization in the pharmaceutical sector for drug formulations also boosts market growth[5].

Eco-Friendly Alternative

Potassium acetate is a non-toxic alternative to potassium chloride, making it a preferred choice in agriculture and de-icing applications, especially under strict environmental regulations[5].

Advanced Production Processes

Improvements in production processes have enhanced manufacturing efficiency and product quality, further fueling the market[5].

Manufacturing Process and Costs

Raw Materials and Expenses

The manufacturing of potassium acetate involves detailed cost analysis, including expenses for raw materials, labor, technology, and overall manufacturing costs. This helps in optimizing the cost structure and identifying strategies to reduce the overall cash cost of manufacturing[5].

Cost Model

A comprehensive cost model is essential for breaking down expenses and ensuring precise cost structure optimization. This model helps manufacturers in making effective decisions regarding product positioning and cost management[5].

Future Projections

Market Growth

The global potassium acetate market is expected to continue its growth trajectory, driven by increasing demand in various sectors. The forecasted growth rate of 2.9% CAGR from 2024 to 2030 indicates a steady and positive market outlook[2][3].

Emerging Opportunities

The market is expected to see significant opportunities in the food and pharmaceutical sectors, as well as in de-icing applications. The shift towards eco-friendly alternatives due to environmental regulations will also drive growth[5].

Key Takeaways

  • Clinical Safety: Potassium acetate is safe for pediatric use but should be used cautiously in pregnant and geriatric patients.
  • Market Growth: The global market is projected to grow from $191 million in 2024 to $226.8 million by 2030 at a CAGR of 2.9%.
  • Market Segmentation: The market is segmented by type (Food Grade, Pharmaceutical Grade, Industrial Grade) and application (Industrial, Pharma & Food, Deicing).
  • Regional Insights: North America, Europe, and Asia-Pacific are key regions driving market growth.
  • Drivers and Trends: Growing demand in food and beverage, pharmaceutical sector, eco-friendly alternative, and advanced production processes are key drivers.

FAQs

Q: What are the primary applications of potassium acetate? A: The primary applications include Industrial, Pharma & Food, and Deicing.

Q: Which region holds the largest market share for potassium acetate? A: North America holds a large market share due to significant pharmaceutical research and development activities.

Q: What is the projected CAGR for the global potassium acetate market from 2024 to 2030? A: The projected CAGR is 2.9%.

Q: Why is potassium acetate preferred over potassium chloride in some applications? A: Potassium acetate is preferred as a non-toxic and eco-friendly alternative, especially under strict environmental regulations.

Q: What are the key drivers of the potassium acetate market? A: Key drivers include growing demand in the food and beverage industry, utilization in the pharmaceutical sector, and its role as an eco-friendly alternative.

Sources

  1. Pfizer Medical Information - Potassium Acetate Injection, USP - VIAL
  2. Valuates Reports - Global Potassium Acetate Market Insights, Forecast to 2030
  3. Cognitive Market Research - Potassium Acetate Market Report 2024 (Global Edition)
  4. Procurement Resource - Potassium Acetate Manufacturing Plant Report 2025: Costs, Process, and Market Trends

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