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

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

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, Heptahydrate

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.

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

Condition Name

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

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Intervention	Trials
Syndrome	7
Dental Caries	6
Renal Insufficiency, Chronic	6
Kidney Diseases	6

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

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Location	Trials
United States	172
Germany	12
India	9
China	9
Israel	7

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Location	Trials
New York	14
California	12
Texas	12
Connecticut	8
North Carolina	8

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

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	25
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Clinical Trial Phase	Trials
Completed	90
Recruiting	23
Unknown status	20

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

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Sponsor	Trials
National Cancer Institute (NCI)	9
OHSU Knight Cancer Institute	5
University of California, San Francisco	4

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Sponsor	Trials
Other	186
Industry	50
NIH	20

Clinical Trials, Market Analysis, and Projections for Amino Acids, Magnesium Chloride, Potassium Chloride, Sodium Chloride, and Sodium Phosphate, Dibasic, Heptahydrate

Introduction

The combination of amino acids, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate, dibasic, heptahydrate is a complex formulation used in various medical and nutritional applications. This article will delve into the clinical trials, market analysis, and projections for these components, highlighting their significance and future outlook.

Clinical Trials and R&D Status

Overview of Clinical Trials

Clinical trials involving amino acids, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate, dibasic, heptahydrate are primarily focused on their therapeutic and nutritional benefits. These trials often investigate their efficacy in treating nutrition disorders, endocrinology and metabolic diseases, and other health conditions.

• Nutrition Disorders: These compounds are often used in parenteral nutrition to provide essential nutrients to patients who cannot absorb them through the digestive system. Clinical trials have shown that these formulations can effectively manage nutrition disorders and support patient recovery[4].

• Endocrinology and Metabolic Diseases: Magnesium chloride and potassium chloride, in particular, play crucial roles in various physiological processes, including muscle function and heart health. Clinical trials have explored their use in treating conditions such as pre-eclampsia and eclampsia during pregnancy[2].

R&D Status

The R&D status for these compounds is active, with ongoing research into their therapeutic applications and formulations.

• Withdrawn and Approved Status: Some formulations involving these compounds have been approved and are in use, while others have been withdrawn from clinical trials. For example, a formulation by Abbott Laboratories was approved in the US in 1986 but has since been withdrawn from certain markets[4].

Market Analysis

Amino Acids Market

• Global Market Size: The global amino acids market was valued at USD 31.23 billion in 2024 and is projected to reach USD 63.95 billion by 2033, growing at a CAGR of 8.5% during the forecast period (2025-2033)[5].

• Applications: Amino acids are essential in pharmaceutical formulations, dietary supplements, and therapeutic treatments. They are used in animal feed, particularly in the Asia-Pacific region, driven by a robust animal feed industry[5].

Magnesium Chloride Market

• Global Market Size: The magnesium chloride market is expected to grow significantly, driven by its use in pharmaceuticals and de-icing. Worldwide sales are projected to reach US$ 3.05 billion by 2034, growing at a CAGR of 6.3%[2].

• Pharmaceutical Grade: Pharmaceutical grade magnesium chloride is expected to hold a significant share of the global market, with a projected value of US$ 1.8 billion by 2034. It is used as a supplement and in medical treatments, including injections for conditions like pre-eclampsia and eclampsia[2].

Potassium Chloride Market

• Global Market Size: The potassium chloride market was valued at USD 727.05 million in 2024 and is projected to reach USD 1018.21 million by 2031, growing at a CAGR of 4.30%[3].

• Applications: Potassium chloride is used in agriculture as a key fertilizer and in the industrial sector for producing potassium-based chemicals. It is also increasingly used in pharmaceuticals for electrolyte replacement therapies and cardiac treatments[3].

Sodium Chloride and Sodium Phosphate, Dibasic, Heptahydrate

• Medical Applications: Sodium chloride and sodium phosphate, dibasic, heptahydrate are used in medical formulations, particularly in parenteral nutrition and as electrolyte supplements. Their market growth is tied to the overall demand for parenteral nutrition solutions and electrolyte replacement therapies[4].

Market Projections

Growth Drivers

• Increasing Health Awareness: Growing health awareness is propelling the use of amino acids in dietary supplements and functional foods, reflecting a shift toward preventative health measures[5].

• Agricultural Demand: The demand for potassium chloride in agriculture, driven by the need for higher crop yields and quality, is expected to continue growing[3].

• Pharmaceutical Applications: The use of magnesium chloride and potassium chloride in pharmaceuticals, particularly in treating magnesium deficiency and as electrolyte supplements, is expected to drive market growth[2][3].

Regional Insights

• Asia-Pacific Region: The Asia-Pacific region, particularly China, is pivotal in the production and consumption of amino acids, driven by a robust animal feed industry[5].

• United States: The United States is forecasted to account for a significant share of the North American market revenue for magnesium chloride by 2034, driven by its use in pharmaceuticals and de-icing[2].

Key Takeaways

• Clinical Trials: Ongoing clinical trials are focused on the therapeutic and nutritional benefits of these compounds, particularly in treating nutrition disorders and endocrinology and metabolic diseases.
• Market Growth: The markets for amino acids, magnesium chloride, and potassium chloride are expected to grow significantly, driven by increasing health awareness, agricultural demand, and pharmaceutical applications.
• Regional Importance: The Asia-Pacific region and the United States are key markets for these compounds, driven by robust animal feed industries and growing pharmaceutical demand.

FAQs

What are the primary applications of amino acids in the market?

Amino acids are used in pharmaceutical formulations, dietary supplements, and therapeutic treatments. They are also crucial in animal feed and human nutrition.

How is the magnesium chloride market expected to grow?

The magnesium chloride market is projected to grow at a CAGR of 6.3% and reach US$ 3.05 billion by 2034, driven by its use in pharmaceuticals and de-icing.

What is the role of potassium chloride in agriculture?

Potassium chloride is used as a key fertilizer to enhance crop yield and quality. It is essential for plant growth, nutrient absorption, and overall health.

What are the therapeutic applications of sodium chloride and sodium phosphate, dibasic, heptahydrate?

These compounds are used in parenteral nutrition and as electrolyte supplements. They are crucial in managing nutrition disorders and supporting patient recovery.

How does the Asia-Pacific region influence the amino acids market?

The Asia-Pacific region, particularly China, is pivotal in the production and consumption of amino acids, driven by a robust animal feed industry.

Sources

1. IndustryARC: Feed Amino Acids Market - Forecast(2024 - 2030)[1].
2. Fact.MR: Magnesium Chloride Market Size, Share & Growth 2034[2].
3. Verified Market Research: Potassium Chloride Market Size, Share, Trends & Forecast[3].
4. Patsnap Synapse: Global Drug Intelligence Database - Amino Acids/Dextrose/Magnesium chloride/Potassium chloride/Sodium chloride/Sodium phosphate, dibasic, heptahydrate[4].
5. Straits Research: Amino Acids Market Size, Share | Forecast Report 2033[5].