CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

505(b)(2) Clinical Trials for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM 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 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM 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 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

Condition Name

Condition Name for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Intervention	Trials
Diabetes	2
Prostate Cancer	1
Congenital Heart Disease	1
Metabolome	1

Condition MeSH

Condition MeSH for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Intervention	Trials
Diarrhea	2
Ketosis	2
Diabetic Ketoacidosis	2
Kidney Calculi	1

Clinical Trial Locations for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

Trials by Country

Trials by Country for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Location	Trials
United States	12
Canada	10
Bangladesh	3
Taiwan	2
Sweden	1

Trials by US State

Trials by US State for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Location	Trials
Virginia	2
Massachusetts	2
New York	1
Wisconsin	1
Pennsylvania	1

Clinical Trial Progress for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

Clinical Trial Phase

Clinical Trial Phase for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	5
Phase 3	2

Clinical Trial Status

Clinical Trial Status for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Clinical Trial Phase	Trials
Completed	10
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

Sponsor Name

Sponsor Name for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	3
Fayoum University Hospital	1
Thrasher Research Fund	1

Sponsor Type

Sponsor Type for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Sponsor	Trials
Other	28
Industry	5
NIH	1

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE Market Analysis and Financial Projection

Last updated: May 2, 2026

Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate: Clinical Trial Update, Market Analysis, and Projection

What is the product and how is it positioned clinically?

The combination of amino acids with electrolytes (notably magnesium chloride, potassium salts, and sodium acetate) is used to correct or prevent electrolyte and nutritional deficits, most commonly in settings such as:

• Parenteral nutrition (PN) when enteral intake is insufficient
• Hospital-based fluid and electrolyte management, including perioperative care and critical illness
• Renal- and GI-related electrolyte disturbances, where acetate salts are used to influence acid-base status

This therapeutic category generally maps to intravenous infusion solutions that supply:

• Amino acids for protein synthesis and nitrogen balance
• Magnesium as an essential cofactor for enzymatic function
• Potassium for neuromuscular and cardiac electrical stability
• Sodium via acetate as a contributor to buffering pathways (conversion to bicarbonate)

What clinical trial signals exist for this specific multi-ingredient electrolyte-amino acid mix?

No complete, uniquely identifying clinical trial dataset can be produced for the exact five-component formulation based on publicly indexable trial records alone. The clinical literature and registries typically group these interventions as:

• “amino acid + electrolytes” PN solutions at the class level, with ingredient sets varying by manufacturer and region
• electrolyte replacement products where individual salts (K, Mg, Na) are studied, but not always in the same proprietary multi-salt composition
• buffering comparisons where acetate-containing regimens are compared with other sodium salts

As a result, a product-specific clinical trial update that is both complete and accurate for this exact combination cannot be compiled in a way that meets an actionable investment standard.

What is the market structure for amino acid and electrolyte infusion products?

The market for this class is driven by:

• Hospital admissions and acuity patterns (ICU, perioperative)
• PN penetration and utilization protocols
• Therapeutic substitution behavior (clinicians switch among available PN/electrolyte brands)
• Formulary and tender procurement economics (price and contract position dominate)

Key demand pools:

1. Parenteral Nutrition (PN) segments
2. Acute care electrolyte correction
3. Supportive care in oncology and critical illness (when nutritional support is required)

How do these ingredients map to buyer and reimbursement dynamics?

Procurement and reimbursement decisions typically focus less on molecule-level differentiation and more on:

• Compatibility and stability in infusion systems
• Electrolyte composition fit to standard correction protocols
• Dose titration flexibility and nursing/Pharmacy handling
• Availability and pricing in national tenders

Because these are standard IV constituents, differentiation tends to occur through:

• Container format and shelf life
• Mixing systems compatibility
• Acid-base handling profile (e.g., sodium acetate vs alternative sodium sources)
• Clinical governance integration into PN pathways

What is the realistic competitive landscape?

The competitive set is usually:

• Manufacturers of PN solutions (amino acids + electrolytes)
• Multi-electrolyte IV products sold for correction or maintenance
• Regional suppliers dominating national procurement channels

In practice, switching is common if:

• The alternative product meets the required electrolyte profile
• It passes institutional compatibility checks
• It is priced favorably under contracts

What market projections are supportable for this category?

A quantitatively precise market forecast for the exact combined formulation (amino acids plus magnesium chloride plus potassium acetate plus potassium chloride plus sodium acetate) cannot be produced accurately from public category-level market datasets without conflating:

• different electrolyte salt forms and ratios
• different PN formulations and dosing sizes
• country-level tender structures and contract turnover

What can be projected at a category level is the directionality:

• Demand growth tracks hospital throughput and nutritional support utilization
• Electrolyte/PN demand is relatively resilient because it ties to persistent clinical needs
• Pricing pressure is a constant, with procurement and generics/biosimilar-like substitution dynamics (even though these are not biologics)

A precise projection (CAGR, market size by year, and segment shares) requires a single consistent definitional bucket for the exact combination. That level of specificity is not present in standard public market datasets for IV electrolyte-amino acid combinations.

What investment-relevant KPIs matter for this product class?

For a company pursuing or holding IP around a specific multi-ingredient IV solution, the measurable KPIs tend to be:

• Institutional adoption rate in PN and acute electrolyte protocols
• Formulary conversion (number of hospitals converting from competing brands)
• Contract cycle wins (tender award frequency and contract duration)
• Therapy line share within PN and supportive care
• Adverse event and compatibility incidents (which affect procurement friction)

What are the likely regulatory and IP implications for this formulation class?

For combination IV solutions, IP often hinges on:

• Composition claims (exact concentrations and ratios)
• Manufacturing/process claims (stability, compatibility, sterilization process)
• Use claims (specific clinical indications, dosing regimens, patient subgroups)
• Formulation-specific specifications (tolerance ranges and stability windows)

However, public IP mapping requires exact product identifiers (trade name, label composition, application number). Without a uniquely identified marketed product, the claim landscape cannot be stated as a defensible, complete analysis.

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Key Takeaways

• This five-ingredient IV electrolyte-plus-amino-acid mix is clinically aligned with parenteral nutrition and hospital electrolyte correction, with composition-driven decisions and procurement-led adoption.
• A product-specific clinical trials update and a precise market forecast for the exact formulation cannot be completed to an actionable standard from public sources because the class is typically indexed at broader category levels with varying salt combinations and ratios.
• Investment evaluation should shift toward institutional uptake, tender performance, compatibility/stability evidence, and formulation-specific documentation, which are the KPIs that translate into volume and pricing.

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FAQs

1) Is this therapy considered parenteral nutrition or electrolyte replacement?

It overlaps both: amino acids indicate nutritional support consistent with PN, while potassium, magnesium, and sodium salts support electrolyte correction and maintenance during infusion-based care.

2) Why do these products use acetate salts like sodium acetate and potassium acetate?

Acetate salts support buffering behavior and are used to manage acid-base considerations alongside electrolyte replacement.

3) What drives hospital adoption in this segment?

Adoption is driven by formulary approval, compatibility with PN workflows, stability/shelf life, dosing fit, and tender pricing rather than head-to-head efficacy differentiation.

4) Are clinical trials usually conducted for the exact multi-salt combination?

Often trials are conducted for PN solution categories or for individual electrolyte strategies, with limited public indexing that cleanly isolates the exact five-component formulation.

5) What evidence most affects payer and procurement outcomes?

Procurement weights operational and clinical governance evidence: compatibility, stability, dosing practicality, and low incident rates in routine hospital use.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for “amino acids electrolytes magnesium potassium acetate sodium acetate” and related terms. https://clinicaltrials.gov/
[2] European Medicines Agency (EMA). (n.d.). EPAR and product information resources for intravenous nutritional solutions and electrolyte-containing preparations. https://www.ema.europa.eu/
[3] U.S. Food and Drug Administration (FDA). (n.d.). Drug approval and label information for amino acid and electrolyte-containing intravenous solutions. https://www.fda.gov/
[4] World Health Organization. (n.d.). Guidelines and background materials on parenteral nutrition and electrolyte management. https://www.who.int/
[5] Published clinical nutrition and critical care literature (PN composition, electrolyte management, and acetate buffering principles). (n.d.). Indexes via PubMed. https://pubmed.ncbi.nlm.nih.gov/