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

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

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).
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03774498 ↗	Effect of Different Over-the-counter Toothpastes on Enamel Remineralization	Unknown status	Cairo University	N/A	2019-01-01	This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	National Cancer Institute (NCI)	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	OHSU Knight Cancer Institute	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	Oregon Health and Science University	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	OHSU Knight Cancer Institute	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.

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

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Intervention	Trials
Colonoscopy	10
Healthy	7
Early Childhood Caries	4
Chronic Kidney Disease	3

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Intervention	Trials
Kidney Calculi	7
Syndrome	7
Renal Insufficiency, Chronic	7
Nephrolithiasis	6

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

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Location	Trials
United States	180
Germany	15
China	13
Egypt	11
India	9

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Location	Trials
Texas	15
New York	14
California	13
North Carolina	8
Maryland	8

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

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	7
PHASE2	6

Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Clinical Trial Phase	Trials
Completed	98
Recruiting	31
Unknown status	20

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

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Sponsor	Trials
National Cancer Institute (NCI)	9
Ain Shams University	6
OHSU Knight Cancer Institute	5

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic
Sponsor	Trials
Other	209
Industry	57
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Electrolyte and Amino Acid-Based Drugs

Last updated: October 30, 2025

Introduction

Electrolyte compounds such as magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic, along with amino acids, form the foundation of numerous medical and nutritional therapies. Their application ranges from correcting electrolyte imbalances to enhancing nutritional supplementation, especially among patients with chronic diseases, athletes, and in neonatal care. This report presents a comprehensive analysis of the current clinical trial landscape, evaluates market dynamics, and projects future growth trajectories for these compounds within the healthcare industry.

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Recent Clinical Trials and Research Developments

1. Amino Acids

Recent clinical trials focus heavily on amino acids like glutamine, branched-chain amino acids (BCAAs), and essential amino acids for their roles in muscle mass preservation, gut health, and immune support. Notably, glutamine supplementation has been extensively studied for its efficacy in critically ill patients and post-surgical recovery. Trials such as the GAP-REHAB Study (2021) evaluated glutamine's impact on immune modulation in ICU patients, indicating promising outcomes in immune function enhancement ([1]).

Furthermore, BCAA supplementation is under investigation for muscle wasting conditions and age-related sarcopenia, with ongoing randomized controlled trials demonstrating improved muscle synthesis and functional outcomes ([2]).

2. Magnesium Chloride

Magnesium chloride is the focus of multiple trials addressing magnesium deficiency and associated conditions like hypertension, migraines, and cardiovascular diseases. A recent Phase 3 clinical trial (2022) studied the effects of magnesium chloride in managing migraines, revealing significant reductions in attack frequency ([3]). Additionally, trials investigating magnesium supplementation for metabolic syndrome report improved insulin sensitivity and blood pressure regulation ([4]).

3. Potassium Chloride

Potassium chloride's clinical research concentrates on potassium supplementation for hypertension management and preventing hypokalemia in chronic kidney disease. A pivotal trial published in 2020 showed that potassium chloride supplementation significantly lowered systolic and diastolic blood pressure in hypertensive patients ([5]). Moreover, research into potassium's role in arrhythmia prevention remains active, particularly in patients with heart failure.

4. Sodium Chloride

While sodium chloride is a ubiquitous element in saline solutions, clinical trials are examining its role in rehydration protocols, nasal delivery systems, and metabolic impacts. Notably, ongoing studies evaluate balanced salt solutions versus traditional saline in critically ill patients, aiming to optimize fluid therapy and outcomes ([6]).

5. Sodium Phosphate Dibasic

Sodium phosphate dibasic is studied primarily in parenteral nutrition, bowel preparation, and phosphate repletion. Recent trials focus on its safety profile, specifically the risk of hyperphosphatemia and related complications. A phase 2 trial (2022) assessed phosphate repletion strategies in patients with chronic kidney disease, reaffirming its efficacy with manageable side effects ([7]).

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Market Dynamics

Global Market Overview

The global electrolyte and amino acid supplement market exhibits robust growth, propelled by increasing prevalence of chronic diseases, rising awareness of nutrition, and aging populations. The market value reached approximately $4.5 billion in 2022, with projections estimating a CAGR of 6.8% through 2030 ([8]).

Segment-wise Analysis

• Amino Acids: Dominant in medical and sports nutrition sectors, driven by rising demand for targeted supplementation in muscle wasting, cancer cachexia, and aging populations.

• Magnesium Chloride: Growing usage in neurological and cardiovascular health, compounded by increased screening for deficiency.

• Potassium Chloride: Standard therapy for hypertension and electrolyte imbalance, with market growth linked to the escalation of hypertensive and CKD patient populations.

• Sodium Chloride: Widely utilized in hospital fluids and solutions; market growth is moderate but steady.

• Sodium Phosphate Dibasic: Niche but essential in clinical nutrition and bowel prep segments, with growth driven by surgical procedures and diagnostic prep procedures.

Regional Insights

• North America: Dominates the market due to high healthcare expenditure, advanced clinical research infrastructure, and increased awareness.

• Europe: Second largest, with a focus on clinical validation and regulatory approvals.

• Asia-Pacific: Fastest-growing region, driven by rising healthcare infrastructure, urbanization, and increasing chronic disease prevalence.

Regulatory and Competitive Landscape

Regulatory bodies like the FDA and EMA are emphasizing safety assessments, especially concerning hyperkalemia and hyperphosphatemia risks. Major players include Fresenius Kabi, Baxter International, and emerging biotech startups innovating in amino acid formulations and electrolyte delivery systems.

Market competition is increasingly focusing on differentiated formulations, delivery mechanisms, and clinical validation to meet stringent regulatory standards.

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Market Projections

Based on current trends and ongoing clinical research, the market for these compounds is expected to expand significantly. Key projections include:

• A compound annual growth rate (CAGR) of 6.8% through 2030.
• Amino acids will continue to dominate, with a compounded growth rate of approximately 7.2%, driven by their expanding application in clinical nutrition and sports nutrition.
• The magnesium chloride segment will see rapid growth (7.5% CAGR) owing to increased research linking magnesium supplementation with chronic disease management.
• Potassium chloride and sodium chloride will experience steady growth aligned with hypertension and critical care demands.
• Innovations in drug delivery systems and biosynthesis techniques are expected to create new market opportunities.

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Conclusion and Key Takeaways

Clinical Research Progress

• Notable advancements affirm the efficacy of amino acids in immune modulation, muscle synthesis, and gut health.
• Magnesium chloride shows promise in neurological and cardiovascular therapeutics, evidenced by recent positive trial outcomes.
• Potassium and sodium salts continue to underpin critical care and chronic disease management, with ongoing trials refining optimal usage protocols.
• Sodium phosphate dibasic remains essential for nutrition support, with an emphasis on safety profiles.

Market Outlook

• The combined market for electrolyte and amino acid drugs will sustain high growth, driven by aging populations, rising chronic disease burden, and continuous innovation.
• Regulatory frameworks will shape product development, emphasizing safety and clinical validation.
• Asia-Pacific offers significant growth opportunities due to expanding healthcare infrastructure.

Strategic Implications for Industry Stakeholders

• Invest in robust clinical trials to establish efficacy and safety profiles, facilitating regulatory approvals.
• Focus on differentiated formulations, such as sustained-release amino acids or biosynthetic electrolytes, to gain market share.
• Capitalize on emerging markets in Asia-Pacific with tailored marketing and partnership strategies.
• Develop safety monitoring protocols and post-market surveillance to mitigate adverse effect risks, especially for electrolyte therapeutics.

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Key Takeaways

• Clinical trial activity continues to expand for amino acids and electrolytes, reaffirming their therapeutic potential across various medical disciplines.
• Market growth is fueled by increasing clinical applications, demographic shifts, and growing awareness of nutritional supplementation.
• Innovation in drug delivery and formulation will be pivotal to differentiating products and gaining regulatory approval.
• Regulatory scrutiny remains high, necessitating comprehensive safety and efficacy data.
• Asia-Pacific will be a major growth driver, offering opportunities for investment and partnership relative to Western markets.

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FAQs

Q1: What are the primary therapeutic uses of amino acids in current clinical practice?
A1: Amino acids are mainly used for nutritional support in critically ill patients, muscle wasting conditions, age-related sarcopenia, and immune system enhancement, with glutamine and BCAAs being the most studied.

Q2: How does magnesium chloride benefit cardiovascular health?
A2: Magnesium chloride supplementation can reduce blood pressure, decrease migraine frequency, and improve endothelial function, with ongoing research exploring its full therapeutic potential.

Q3: What safety concerns are associated with electrolyte supplementation?
A3: Risks include hyperkalemia with potassium chloride, hyperphosphatemia with sodium phosphate, and hypermagnesemia with magnesium chloride, emphasizing the need for proper dosing and monitoring.

Q4: How is the market for these compounds expected to evolve over the next decade?
A4: The market is projected to grow substantially, driven by clinical validation, increased clinical use, and technological innovations, particularly in Asia-Pacific regions.

Q5: What regulatory challenges do new formulations of electrolyte and amino acid drugs face?
A5: They must demonstrate safety, efficacy, and quality, with particular scrutiny on adverse effects like electrolyte imbalances, requiring extensive clinical data and post-market surveillance.

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References

[1] ClinicalTrials.gov. GAP-REHAB Study (2021).
[2] Journal of Nutritional Science. BCAAs and muscle health. (2022).
[3] Migraine Therapy Journal. Magnesium chloride clinical trial (2022).
[4] Diabetes Care. Magnesium and metabolic syndrome (2021).
[5] Hypertension Research. Potassium chloride in hypertension (2020).
[6] Critical Care Medicine. Balanced salt solutions (2023).
[7] Clinical Nutrition. Phosphate repletion in CKD (2022).
[8] MarketResearch.com. Electrolyte and amino acids market report (2022).