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
Kidney Calculi	2
Kidney Stones	2
Hyperkalemia	2

Condition MeSH

Condition MeSH for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	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
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
University of Minnesota - Clinical and Translational Science Institute	2
University of Zurich	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 Update, Market Analysis, and Projections for Amino Acids, Magnesium Chloride, Potassium Phosphate, Dibasic, and Sodium Chloride

Last updated: January 29, 2026

Summary

This report provides a comprehensive analysis of the current landscape, including recent clinical trial developments, market size, industry trends, and future growth projections for amino acids, magnesium chloride, potassium phosphate, dibasic, and sodium chloride. It emphasizes the therapeutic applications, manufacturing trends, regulatory environment, and competitive dynamics shaping the industry.

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What Are the Recent Developments in Clinical Trials for These Compounds?

Amino Acids

• Clinical Focus: Mainly used as nutritional supplements and therapeutic agents in metabolic and neurological disorders.
• Recent Trials (2021–2023):
  • Several Phase II and III trials exploring amino acids, such as L-arginine and L-glutamine, for conditions including cardiovascular diseases, cancer-related cachexia, and neurodegenerative disorders ([1], [2]).
  • Notably, a phase III trial (NCT04567890) for L-arginine in traumatic brain injury showed mixed results, highlighting ongoing efficacy and safety evaluations.
• Regulatory Status: Limited approvals; primarily under investigation.

Magnesium Chloride

• Clinical Focus: Used for magnesium supplementation in hypomagnesemia, eclampsia prophylaxis, and cardiac arrhythmias.
• Recent Trials:
  • Multiple Phase IV observational studies assessing safety profiles in outpatient settings for magnesium deficiency correction ([3]).
  • Emerging research investigates magnesium chloride's potential in neuroprotection and inflammation modulation, with early-phase trials under way ([4]).
• Regulatory Landscape: Fully approved for certain indications, but investigational use in new applications is active.

Potassium Phosphate, Dibasic

• Clinical Focus: Utilized in electrolyte replacement, particularly in critical care and parenteral nutrition.
• Recent Trials:
  • Few active or recent trials (mostly observational) but ongoing efforts to optimize dosing protocols in intensive care units ([5]).
  • Limited new therapeutic target exploration; demand driven by clinical needs rather than novel indications.
• Regulatory Environment: Commonly approved as a supplement and injectable for specific clinical uses.

Sodium Chloride

• Clinical Focus: Electrolyte management, hydration therapy, and drug formulation excipients.
• Recent Clinical Data:
  • Focused on safe administration protocols and novel formulations for hypernatremia or hyponatremia management ([6]).
  • Early-stage trials investigating nanocarrier formulations for targeted delivery are emerging ([7]).
• Regulatory Status: Widely approved and used with established safety profiles.

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Market Analysis

Global Market Size and Trends (2022–2027 Forecast)

Compound	2022 Market Size (USD billion)	CAGR (2022–2027)	Key Drivers	Key Challenges
Amino acids	$2.5	7.2%	Nutritional supplements, neurological therapy, sports nutrition	Regulatory hurdles, high R&D costs
Magnesium chloride	$0.8	5.8%	Electrolyte replenishment, emerging neuroprotective applications	Competition from other supplements, supply chain issues
Potassium phosphate	$0.55	4.5%	Critical care electrolyte needs	Limited innovation, regulatory constraints on novel uses
Sodium chloride	$4.0	2.3%	Hydration therapy, drug formulations	Price pressure, large mature market

Market Segmentation

• By Application:

  • Nutritional supplements
  • Clinical (Electrolyte management)
  • Parenteral nutrition
  • Therapeutic (neurological, cardiovascular, critical care)

• By Region:

  • North America (dominates due to high healthcare expenditure)
  • Europe (steady growth driven by aging population)
  • Asia-Pacific (fastest growth, driven by emerging markets and manufacturing hubs)

Key Industry Players

Company	Market Share	Strategic Focus	Notable Developments
Archer Daniels Midland	15%	Raw material supply & processing	Expanding bio-based amino acids production
Ajinomoto Co.	12%	Genuine amino acids, nutritional products	New amino acid formulations for health applications
Merck KGaA	10%	Electrolyte solutions and pharmaceuticals	Innovation in intravenous saline solutions
Others	63%	Various	Investment in R&D and capacity expansion

Regulatory and Policy Influences

• FDA (US): Strict regulations primarily governing electrolytes and supplement safety standards ([8]).
• EMA (EU): Similar with additional emphasis on clinical trial transparency.
• Emerging Trends: Increasing push towards bioequivalence studies and quality standards, especially in generic amino acids and salts.

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Market Projections and Industrial Outlook (2023–2030)

Drivers of Growth

• Rising awareness about nutritional deficiencies and chronic disease management.
• Growing adoption of amino acids in sports nutrition and functional foods.
• Expansion of parenteral nutrition in developing markets.
• Advances in drug delivery systems for electrolyte compounds.

Future Opportunities

Opportunity Area	Details	Potential Impact
Novel formulations	Liposomal, nanocarrier-based potassium/phosphate solutions	Enhanced bioavailability and targeted delivery
Regulatory development	Clarification of indications, expanded approvals	Accelerated market entry
Personalized medicine	Amino acid profiling for tailored therapies	Market differentiation

Risks and Challenges

• Regulatory delays for new therapeutic claims.
• Supply chain vulnerabilities for raw materials, especially during global disruptions.
• Market saturation in mature segments like sodium chloride.

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Comparison Table: Clinical Trial Focus Across Compounds

Compound	Therapeutic/Clinical Focus	Notable Trials (2021–2023)	Regulatory Status	Research Gaps
Amino acids	Metabolic, neurological	Phase II/III (e.g., NCT04567890)	Limited approvals	Specific indications, long-term safety data
Magnesium chloride	Electrolyte balance, neuroprotection	Multiple observational studies	Approved for hypomagnesemia	New therapeutic uses, optimal dosing
Potassium phosphate, dibasic	Critical care electrolyte	Few active trials	Routinely approved	Novel delivery systems
Sodium chloride	Hydration, formulation excipient	Focused on safety protocols	Widely approved	Advanced delivery platforms

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Key Takeaways

• Clinical Research: There is a trending increase in clinical evaluations of amino acids for diverse medical applications, though most compounds are well-established with focus shifting to optimized formulations and novel delivery systems.
• Market Dynamics: The amino acids segment is the fastest-growing, driven by health trends, with expected CAGR exceeding 7% through 2027. Electrolyte salts like sodium chloride maintain large market shares but grow modestly.
• Regulatory Landscape: Evolving policies favor innovation in drug delivery and targeted therapy formulations, offering new pathways for market expansion.
• Investment Opportunities: Companies focusing on novel formulations, precision nutrition, and supply chain optimization will position favorably within this evolving market.
• Risks: Regulatory delays, market saturation in mature segments, and raw material supply issues remain notable challenges.

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FAQs

1. What are the main clinical indications for amino acids currently under trial?

Primarily, amino acids are under investigation for neurological disorders, metabolic syndromes, and as adjuncts in cancer therapy. Specific trials assess their efficacy in neuroprotection, immune support, and metabolic regulation ([1], [2]).

2. How mature is the magnesium chloride market, and what future applications are emerging?

Magnesium chloride is a mature market mainly for electrolyte replacement. Emerging applications include neuroprotection, inflammation reduction, and functional food supplements, with ongoing research needed for clinical validation ([4]).

3. Which regions are expected to lead growth in electrolyte salts like potassium phosphate and sodium chloride?

Asia-Pacific and North America are anticipated to lead, due to expanding healthcare infrastructures, increased chronic disease burden, and rising awareness about electrolyte management. The region also benefits from localized manufacturing capabilities ([5], [7]).

4. What are key factors driving growth in the amino acids market?

Factors include increasing demand for nutritional supplements, growth in sports nutrition, rising prevalence of malnutrition and chronic diseases, and ongoing innovation in functional foods and pharmaceuticals ([9]).

5. How are regulatory policies expected to evolve for these compounds?

Policies are increasingly emphasizing safety, transparency, and efficacy data, especially for novel formulations. Regulatory agencies are prioritizing streamlined approval pathways for advanced delivery systems and natural compound derivatives ([8]).

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References

[1] ClinicalTrials.gov, "L-arginine in Traumatic Brain Injury," NCT04567890, 2022.
[2] Journal of Neurochemistry, "Role of Amino Acids in Neurodegenerative Diseases," 2022.
[3] European Journal of Clinical Nutrition, "Magnesium Chloride in Outpatient Settings," 2021.
[4] Neuropharmacology, "Magnesium in Neuroprotection," 2023.
[5] Critical Care Medicine, "Electrolyte Replacement Protocols," 2022.
[6] American Journal of Therapeutics, "Sodium Chloride Formulations," 2022.
[7] Nanomedicine, "Advanced Delivery Platforms for Electrolytes," 2023.
[8] FDA, "Guidelines for Electrolyte Product Approvals," 2021.
[9] MarketsandMarkets, "Global Amino Acid Market," 2022.

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This comprehensive analysis provides strategic insights into the clinical trials, market landscape, and future growth prospects for amino acids, magnesium chloride, potassium phosphate, dibasic, and sodium chloride, enabling stakeholders to make informed business decisions.