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

505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; 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 Acetate; 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
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Santander	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

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

Condition Name

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

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; 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 Acetate; Sodium Chloride

Trials by Country

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

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; 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 Acetate; Sodium Chloride

Clinical Trial Phase

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

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Sponsor	Trials
University of Minnesota	3
Rigshospitalet, Denmark	2
National Institute of General Medical Sciences (NIGMS)	2

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Sponsor	Trials
Other	68
Industry	11
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Amino Acids and Electrolyte Compounds

Last updated: October 29, 2025

---

Introduction

The global market for amino acids and electrolyte compounds—including magnesium chloride, potassium phosphate dibasic, sodium acetate, and sodium chloride—is experiencing dynamic shifts driven by advances in clinical research, increasing demand from diverse sectors, and regulatory developments. This analysis provides a comprehensive update on ongoing and upcoming clinical trials, evaluates current market conditions, and projects future trends to inform strategic decision-making.

---

Clinical Trials Landscape

Amino Acids

Amino acids, pivotal for nutritional supplementation and therapeutic purposes, continue to garner research interest. Recent clinical trials focus on their use in neurodegenerative diseases, metabolic disorders, and immune support. Notably, trials exploring branched-chain amino acids (BCAAs) for sarcopenia and cognitive health are prominent, with several phase II and III studies underway globally.

Key developments:

• Neurodegenerative therapeutic trials: Ongoing studies evaluating amino acid derivatives in Alzheimer’s and Parkinson’s disease management aim to elucidate neuroprotective roles. For example, trials assessing N-Acetylcysteine (NAC) are nearing completion, with preliminary data suggesting potential benefits in oxidative stress reduction.

• Metabolic disorder interventions: Numerous trials explore amino acids like L-arginine and L-glutamine in insulin sensitivity and gut health, with some showing positive efficacy signals, pending larger confirmatory studies.

Magnesium Chloride

Magnesium chloride is chiefly examined for its role in cardiovascular health, migraine prophylaxis, and electrolyte stabilization. Clinical trials registered in the last two years emphasize supplementation efficacy in deficiencies and chronic conditions.

Notable trials:

• Cardiovascular health: Several phase II studies indicate magnesium chloride’s potential in reducing hypertension and arrhythmias, with some studies exploring oral versus intravenous administration.

• Migraine management: Trials demonstrate efficacy in migraine frequency reduction, with magnesium chloride’s safety profile well-established.

Potassium Phosphate, Dibasic

Research centers on its application in parenteral nutrition, electrolyte replacement, and kidney health. Recent clinical trials focus on optimizing dosing, safety, and efficacy in various patient populations.

Recent outcomes:

• Electrolyte repletion: Trials support its use in critically ill patients, with attention to preventing hyperkalemia.

• Chronic kidney disease (CKD): Some studies explore its role in managing mineral and electrolyte imbalances in CKD, seeking to improve patient outcomes.

Sodium Acetate and Sodium Chloride

Both compounds feature in critical care, nutrition, and dialysis procedures.

• Sodium acetate: Current research investigates its metabolic effects and utility as an alternative buffer in resuscitation solutions, with ongoing phase II trials focused on sepsis and acidosis.

• Sodium chloride: The focus remains on infusion therapies in dehydration, electrolyte correction, and dialysis, with recent trials assessing optimal dosing strategies to minimize adverse effects.

---

Market Overview

Market Size and Dynamics

The global market for amino acids and electrolyte compounds was valued at approximately USD 6.3 billion in 2022[1]. The segment is driven by rising prevalence of chronic diseases, expanding nutritional and supplement markets, and growth in critical care and hospital pharmacy sectors.

Key drivers include:

• Nutritional supplementation: The rising awareness of amino acids for sports nutrition, aging populations, and clinical nutrition strengthens demand.
• Therapeutic applications: Increasing reliance on electrolyte replenishment therapies in hospitals and emergency care sustains steady revenue streams.
• Regulatory approvals and new formulations: Innovations such as oral amino acid formulations and improved electrolyte infusion solutions sustain growth momentum.

Segment Performance and Regional Insights

• Amino acids: North America dominated the market in 2022, accounting for 45%, primarily due to advanced healthcare infrastructure and high R&D activity, with Asia-Pacific projected to grow at an 8.2% CAGR owing to expanding healthcare access.

• Electrolytes (magnesium chloride, potassium phosphate, sodium acetate, sodium chloride): The electrolytes market is poised for a compound annual growth rate (CAGR) of approximately 7% over the next five years. Critical care, neonatal, and sports nutrition markets notably contribute to this expansion.

Market Challenges

• Regulatory hurdles: Stringent approval pathways for new formulations and indications can delay commercialization.
• Pricing pressures: Cost sensitivity among healthcare providers and consumers necessitates cost-effective manufacturing and distribution strategies.
• Supply chain disruptions: Raw material shortages, especially of specialty amino acids, have impacted production stability.

---

Future Projections

Growth Outlook and Trends

• The amino acids market is expected to reach USD 9.2 billion by 2030, driven by rising health awareness, innovation in functional foods, and personalized medicine approaches.
• Electrolyte compounds, particularly magnesium chloride and sodium salts, will see growth propelled by increasing adoption in preventive health, sports medicine, and critical care.

Innovation and R&D

• Post-pandemic, there's an emphasis on integrating amino acids and electrolytes into combination therapies for enhanced efficacy.
• Development of sustainable, plant-based amino acid sources and biodegradable electrolyte formulations aligns with environmental sustainability trends.
• Personalized nutrition based on genetic markers may influence future clinical trial designs and market offerings.

Regulatory and Market Expansion

• Anticipated approvals for novel amino acid derivatives and electrolyte formulations in emerging markets bolster global reach.
• Enhanced collaboration between biotech companies and hospitals will accelerate clinical validation and adoption.

---

Key Takeaways

• Clinical trial activity remains robust, with promising advances for amino acids in neuroprotection and metabolic health, and for electrolyte compounds in critical care.
• The market is undergoing steady expansion, with Asia-Pacific offering significant growth potential due to rising healthcare infrastructure.
• Innovation in formulations, personalized medicine, and sustainability will shape future product development.
• Regulatory navigation remains pivotal; companies must proactively engage with authorities to streamline approval processes.
• Investment in supply chain resilience and cost optimization will be critical for competitive advantage.

---

FAQs

1. What are the most promising clinical developments in amino acid therapies?
Ongoing trials focusing on neurodegenerative diseases and metabolic disorders show potential, especially with derivatives like N-Acetylcysteine and BCAAs demonstrating neuroprotective and metabolic benefits.

2. How is the electrolyte market evolving amidst global health challenges?
The electrolyte market is growing consistently, driven by increased demand in critical care, sports medicine, and nutrition. Innovations in infusion therapies and better supply chain management support this growth.

3. What potential regulatory hurdles could impact market expansion?
Stringent approval pathways, especially for new formulations and indications, could delay commercialization. Companies must engage early with regulators to mitigate these risks.

4. Which regions are expected to outperform in electrolyte compound markets?
The Asia-Pacific region is projected to outperform others in CAGR, fueled by expanding healthcare access, industrialization, and aging demographics.

5. What strategic considerations should stakeholders prioritize?
Investing in R&D, strengthening supply chains, and aligning product innovations with regulatory standards are essential for capturing growth opportunities.

---

Sources

[1] Market Data Forecast, 2023. "Global Amino Acids and Electrolytes Market."