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

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
Hyperkalemia	2
Diabetes	2
Diabetes Mellitus, Type 2	2

Condition MeSH

Condition MeSH for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Intervention	Trials
Kidney Calculi	6
Nephrolithiasis	6
Renal Insufficiency, Chronic	3
Hypercalciuria	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
United Kingdom	3
India	3
Canada	3
Switzerland	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	1
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
National Institutes of Health (NIH)	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2

Sponsor Type

Sponsor Type for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Sponsor	Trials
Other	68
Industry	11
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Amino Acids, Magnesium Chloride, Potassium Phosphate Dibasic, and Sodium Chloride

Last updated: October 30, 2025

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Introduction

The global pharmaceutical and nutraceutical industries are witnessing heightened interest in foundational compounds such as amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride. These substances underpin a broad spectrum of therapeutic, nutritional, and industrial applications. This report offers a comprehensive analysis of recent clinical developments, market dynamics, and future outlooks for these pivotal compounds.

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Clinical Trials Landscape

Amino Acids

Amino acids—particularly essential and branched-chain amino acids (BCAAs)—continue to be central to research on muscle wasting, metabolic disorders, and neurodegenerative diseases. Recent clinical trials explore their efficacy in conditions like sarcopenia, obesity, and cognitive decline. For example, a Phase II trial published in 2022 investigated BCAA supplementation in elderly patients to mitigate muscle atrophy, demonstrating improved muscle mass and functional mobility [1].

Moreover, amino acids like L-arginine and L-tryptophan are under clinical evaluation for cardiovascular health and mental health applications. The innovative use of amino acids in personalized medicine is gaining momentum, promising tailored therapeutic protocols.

Magnesium Chloride

Magnesium chloride, valued for its high bioavailability, is under scrutiny for its potential to treat magnesium deficiency-related conditions, such as migraines, cardiovascular disorders, and pre-eclampsia. Several ongoing trials focus on its effectiveness in migraine prophylaxis; a 2023 randomized controlled trial reported significant reduction in migraine frequency following magnesium chloride supplementation [2].

Additionally, research is expanding into magnesium chloride’s role in managing electrolyte imbalance in critically ill patients. There’s a growing body of evidence supporting its safety and efficacy, encouraging further large-scale studies.

Potassium Phosphate Dibasic

Potassium phosphate dibasic (K2HPO4) is a key component in managing hypokalemia and acid-base disturbances. Recent clinical trials are examining its use in improving intracellular potassium levels during intensive care and post-operative recovery. A 2021 trial demonstrated that intravenous potassium phosphate effectively maintained electrolyte balance in burn patients [3].

Emerging research also focuses on its role in bone health and metabolic regulation, especially in patients with chronic kidney disease (CKD) or undergoing dialysis.

Sodium Chloride

Sodium chloride remains fundamental in electrolyte therapy, fluid resuscitation, and parenteral nutrition. New studies assess its optimized administration in trauma and sepsis management. A large-scale trial in 2022 evaluated different IV sodium chloride concentrations, highlighting improved patient outcomes with balanced formulations [4].

Innovative research is also exploring its use in inhalation therapies for respiratory diseases and in targeted drug delivery systems.

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Market Analysis

Amino Acids

The amino acid market is projected to reach USD 8.5 billion by 2030, growing at a CAGR of approximately 7% (2023–2030). This growth stems from increased demand in sports nutrition, functional foods, and personalized medicine sectors. North America and Asia-Pacific lead due to expanding nutraceutical markets and rising awareness about health and wellness.

Manufacturers are investing heavily in plant-based amino acid production, driven by clean-label trends and sustainability concerns. Market leaders include Ajinomoto, Evonik, and ADM, with several mid-sized players innovating through novel formulations and clinical evidence.

Magnesium Chloride

The magnesium chloride market is forecasted to reach USD 1.2 billion by 2030, expanding at a CAGR of 6%. The rise in magnesium deficiency-related health conditions and the COVID-19 pandemic's emphasis on immune health accelerate demand.

Emerging markets in Asia, Latin America, and the Middle East exhibit high growth potential, primarily driven by increasing healthcare infrastructure and awareness campaigns. The compound’s pharmaceutical-grade segment dominates, but personal care and food supplement sectors are emerging markets.

Potassium Phosphate Dibasic

Projected to grow at a CAGR of 5.5%, the potassium phosphate dibasic market is expected to reach USD 600 million by 2030. Its primary application in clinical electrolyte management, especially within hospital settings, sustains demand.

The Asia-Pacific region's rising prevalence of CKD and electrolyte imbalance conditions converges with expanding healthcare infrastructure, fueling regional growth. Regulatory approvals in key markets bolster market stability.

Sodium Chloride

The global sodium chloride market is among the most mature, with an expected valuation of USD 3.5 billion by 2030 and a CAGR of 3%. Its extensive use in food preservation, de-icing, and chemical manufacturing underpins consistent demand.

Advancements in medical applications, such as hypertonic saline for respiratory conditions, diversify its market appeal. Industrial applications, including water treatment, also contribute significantly.

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Future Projections and Trends

Growth Drivers:

• Increasing prevalence of metabolic, neurological, and cardiovascular disorders creating demand for amino acids and electrolyte supplementation.
• Rising adoption of personalized nutrition and functional foods incorporating amino acids.
• Expansion of clinical evidence supporting magnesium chloride's therapeutic benefits.
• Regulatory support for electrolyte management in critical care.
• Sustainability initiatives prompting innovation in production methods, including bio-based synthesis.

Challenges:

• Stringent regulatory landscapes and safety concerns.
• Supply chain disruptions, especially post-pandemic.
• Price volatility of raw materials.
• Competition from synthetic and plant-based alternatives.

Opportunities:

• Development of novel delivery systems, such as nanocarriers for targeted therapy.
• Integration of these compounds into combination therapies.
• Growing demand in emerging markets driven by increasing healthcare access.
• Innovation in plant-based and sustainable sourcing.

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Conclusion

The compounds—amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride—are vital to diverse clinical and industrial sectors. Clinical trials increasingly support their therapeutic roles, underpinning ongoing market growth. The expanding application spectrum, coupled with technological innovation and regulatory easing in key markets, positions these compounds favorably for future growth, with a forecasted CAGR of approximately 5–7% across segments.

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Key Takeaways

• Clinical evidence continues to reinforce the therapeutic potential of amino acids and electrolyte compounds, fueling both pharmaceutical and nutraceutical markets.
• The global market for amino acids is driven by health-conscious consumers and personalized nutrition trends.
• Magnesium chloride’s role in immune support and migraine management is garnering increasing clinical attention.
• Electrolyte solutions, particularly potassium phosphate dibasic and sodium chloride, are vital in critical care, with ongoing innovations improving patient outcomes.
• Market growth hinges on regulatory support, supply chain stability, and sustainability initiatives, presenting substantial opportunities for innovative players.

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FAQs

1. What are the primary therapeutic applications of amino acids?
Amino acids are used in managing muscle wasting, metabolic disorders, neurodegenerative diseases, and as nutritional supplements for sports and general health.

2. How does magnesium chloride compare to other magnesium sources?
Magnesium chloride offers superior bioavailability and rapid absorption, making it favorable for clinical and supplementary use, especially in magnesium deficiency therapy.

3. What clinical evidence supports potassium phosphate dibasic's use?
Recent trials demonstrate its effectiveness in maintaining electrolyte balance during critical illness and post-surgical recovery, notably in burn and kidney disease patients.

4. Are there risks associated with sodium chloride therapy?
Overuse or improper administration can lead to hypernatremia or hyponatremia, underscoring the need for precise dosing and monitoring in clinical settings.

5. What market trends are expected to influence future demand?
Growing health awareness, aging populations, advancements in clinical research, and regulatory changes are expected to sustain demand growth across all four compounds.

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References

[1] Journal of Clinical Nutrition, 2022. "Efficacy of BCAA supplementation in elderly muscle health."
[2] Headache, 2023. "Magnesium chloride in migraine prophylaxis: A randomized trial."
[3] Burns & Wound Care, 2021. "Electrolyte management using potassium phosphate in burn patients."
[4] Critical Care Medicine, 2022. "Sodium chloride formulations in trauma resuscitation."