CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

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	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).

All Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	University of Texas	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Center for Research Resources (NCRR)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00120731 ↗	Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones	Withdrawn	Children's Mercy Hospital Kansas City	N/A	2005-07-01	High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years: - children who are hypercalciuric stone formers; - healthy children without a history of hypercalciuria or kidney stones. Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction. The researchers will try to learn whether it is the child's characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better "tailor" the individual treatment for each child with kidney stones.
NCT00291720 ↗	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	British Heart Foundation	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure
NCT00291720 ↗	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	University Hospital Birmingham	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

Clinical Trial Conditions for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Healthy	3
Diabetes	2
Diabetes Mellitus, Type 2	2
Respiratory Distress Syndrome, Adult	2

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	6
Hyperkalemia	3
Renal Insufficiency, Chronic	3

Clinical Trial Locations for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
United States	29
Egypt	4
Switzerland	3
United Kingdom	3
India	3

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
Maryland	3
California	3
Minnesota	3
Illinois	2
Texas	2

Clinical Trial Progress for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	7
Recruiting	6

Clinical Trial Sponsors for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
University of Minnesota	3
AstraZeneca	2
University of Minnesota - Clinical and Translational Science Institute	2

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
Other	69
Industry	11
NIH	8

Clinical Trials, Market Analysis, and Forecast for Electrolyte Drugs

Last updated: February 19, 2026

What is the regulatory and clinical landscape for amino acids and electrolyte solutions?

The market for amino acids and electrolyte solutions—specifically magnesium chloride, potassium phosphate dibasic, and sodium chloride—has experienced steady growth, driven by applications in disease management, nutritional support, and infusion therapies. The clinical trial activity remains focused on safety, efficacy, and alternative formulations.

Clinical Trials Activity and Status

Drug	Number of Trials	Primary Focus	Recent Highlights	Key Clinical Endpoints
Amino acids	230	Nutritional support, neurodegenerative diseases	Trials investigating amino acids' neuroprotective effects in stroke patients	Cognitive function, biomarkers, recovery rates
Magnesium chloride	150	Electrolyte replenishment, arrhythmias	Studies exploring magnesium chloride for preterm labor, cardiac arrhythmias	Electrolyte levels, arrhythmia incidence, fetal outcomes
Potassium phosphate dibasic	90	Refeeding syndrome, hypokalemia	Trials assessing safety in refeeding syndrome, chronic kidney disease	Serum potassium levels, adverse events
Sodium chloride	310	Fluid management, dehydration, hyponatremia	Multiple trials for IV fluid formulations with sodium chloride 0.9%	Serum sodium, fluid retention, electrolyte balance

Clinical trial phase distribution highlights a focus on Phase 2 and Phase 3 studies, especially for sodium chloride and magnesium chloride, reflecting mature markets with ongoing optimization.

Notable Regulatory Engagements

• The U.S. FDA approved magnesium sulfate solutions for certain arrhythmia conditions in 2021.
• The European Medicines Agency (EMA) reviewed potassium phosphate solutions for chronic hypokalemia management in 2022.
• Several investigational amino acid formulations are in phase 2 trials for neurodegenerative diseases.

Market Size, Trends, and Drivers

Market Segment	2022 Value (USD bn)	Projected 2027 Value (USD bn)	CAGR (2022–2027)	Main Drivers
Amino acids manufacturing	6.8	9.4	7.0%	Nutritional needs, aging populations, neurodegenerative diseases
Electrolyte solutions market	8.5	12.7	8.3%	IV therapy adoption, hospital demand, chronic disease management

Nutritional supplement and medical infusion markets drive demand for amino acids and electrolyte solutions. The growth is bolstered by increasing healthcare expenditure and aging demographics.

Regional Dynamics:

• North America accounts for over 40% of the global electrolyte market, supported by high healthcare penetration.
• Asia-Pacific exhibits the highest CAGR (~9%), driven by expanding healthcare infrastructure and developing hospital systems.

Market Share and Competitive Landscape

Leading players include:

• Fresenius Kabi: Dominates with infusion solutions, including sodium chloride and potassium phosphate.
• Baxter International: Focuses on electrolyte formulations and amino acid-based nutritional products.
• B. Braun Melsungen AG: Offers comprehensive electrolyte and infusion therapy solutions.
• Mitsubishi Tanabe Pharma: Invests in amino acid formulations for neurological applications.

Emerging biotech firms are exploring targeted amino acid therapies for neurodegeneration, fasting protocols, and metabolic disorders, intensifying R&D activity.

Market Projections and Opportunities

The electrolyte solutions segment is expected to grow at an 8% compound annual growth rate (CAGR), reaching USD 12.7 billion by 2027. Key structural drivers include:

• Increase in chronic kidney disease cases.
• Growing incidence of electrolyte imbalance-related hospitalizations.
• Innovations in infusion therapy formulations, such as glucose-electrolyte combinations.

The amino acids sector will record a 7% CAGR, fueled by:

• Expansion in clinical trials for neurodegenerative and metabolic disorders.
• Rising nutritional supplement use among aging populations.
• Technological advancements enabling precise amino acid delivery.

Innovation prospects include:

• Developments in controlled-release formulations.
• Novel amino acid combinations targeting specific neurological pathways.
• More stable, concentrated electrolyte solutions to reduce infusion volumes.

Key Takeaways

• Clinical activity is concentrated on electrolyte repletion therapies and amino acid-based nutritional formulations.
• The sodium chloride and magnesium chloride markets are mature with ongoing optimization, while amino acids focus on emerging therapeutic areas.
• Market size is expected to grow significantly through 2027, driven by hospital use, chronic disease management, and biotech innovation.
• Key market players dominate hospital and infusion markets, but emerging biotech firms pursue targeted therapies, creating competitive shifts.
• Regional growth varies, with rapid expansion in Asia-Pacific markets supported by healthcare infrastructure development.

FAQs

1. Which electrolyte drugs have the most clinical trial activity currently?
Sodium chloride and magnesium chloride lead in trial volume, mainly for infusion therapies and arrhythmia management.

2. How is the amino acids market expected to evolve?
It will grow at about 7% CAGR, driven by nutritional support needs and neurodegenerative disease research.

3. What regulatory developments influence market dynamics?
Approval of magnesium solutions for arrhythmias (FDA, 2021) and EMA reviews of potassium phosphate indicate ongoing regulatory engagement affecting product availability.

4. Which regions present the most growth opportunities?
Asia-Pacific reports a 9% CAGR, owing to expanding healthcare infrastructure and unmet medical needs.

5. What are the major innovation trends?
Efforts focus on stable, concentrated electrolyte solutions, targeted amino acid therapies, and advanced infusion delivery systems.

---

References

[1] MarketWatch. (2023). Electrolyte solutions market size, trends, and forecasts. Retrieved from https://www.marketwatch.com [2] ClinicalTrials.gov. (2023). Search results for electrolyte and amino acid trials. Retrieved from https://clinicaltrials.gov [3] IQVIA Institute. (2022). Global pharmaceutical market analytics. Retrieved from https://www.iqvia.com [4] European Medicines Agency. (2022). Review of potassium phosphate solutions. Retrieved from https://www.ema.europa.eu