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

505(b)(2) Clinical Trials for Amino Acids; Dextrose; 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; Dextrose; 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.
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.

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

Condition Name

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

Condition MeSH

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

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

Trials by Country

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

Trials by US State

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

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

Clinical Trial Phase

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

Clinical Trial Status

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

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

Sponsor Name

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

Sponsor Type

Sponsor Type for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Sponsor	Trials
Other	208
Industry	57
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Intravenous Electrolyte Solutions: Amino Acids, Dextrose, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate

Last updated: October 29, 2025

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Introduction

Intravenous (IV) electrolyte solutions remain fundamental in clinical settings for restoring fluid and electrolyte balance, especially in critical care, surgery, and chronic disease management. The compound portfolio under review—amino acids, dextrose, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic, heptahydrate—constitutes key components of many IV formulations. The evolving landscape, driven by advances in clinical research, regulatory shifts, and market dynamics, necessitates an updated analysis of the current status, ongoing trials, and future growth projections.

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Clinical Trials Landscape

Current Clinical Research Trends

Recent years have witnessed a surge in clinical trials focused on optimizing electrolyte composition, dosing regimens, and stability profiles of IV solutions containing these ingredients. There is an emphasis on tailored formulations for specific patient populations, such as pediatrics, geriatrics, and those with renal or hepatic impairments.

Amino Acids and Dextrose

A significant body of ongoing research examines amino acids combined with dextrose for parenteral nutrition (PN). These trials aim to enhance nutritional efficacy, minimize complications like refeeding syndrome, and improve patient outcomes [1]. For instance, randomized controlled trials (RCTs) are evaluating amino acid infusion protocols supplemented with dextrose to modulate immune responses post-surgery.

Electrolyte Components: Magnesium, Potassium, Sodium, and Phosphate

Key trials evaluate the safety and efficacy of electrolyte correction strategies, especially in critical care settings. Trials like NCT04567891 investigate magnesium chloride infusion safety in refractory hypomagnesemia, while others assess the role of potassium chloride and sodium chloride in managing electrolyte imbalances during renal replacement therapy.

Regulatory and Safety Focus

Recent trial protocols explore the stability, compatibility, and adverse effect profiles of these electrolyte solutions, emphasizing the importance of correct dosing, infusion rates, and patient safety [2].

Clinical Trial Challenges

Recruitment remains stalled in some regions due to regulatory hurdles and logistical complexities, especially in pediatric or rare disease cohorts. Nonetheless, technological innovations, including remote monitoring and adaptive trial designs, are facilitating progress.

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Market Analysis

Market Size and Growth Dynamics

The global market for IV electrolyte solutions, including amino acids, dextrose, and mineral salts, was valued at approximately USD 8.5 billion in 2022, with a compound annual growth rate (CAGR) of 5% forecasted through 2030 [3]. Factors influencing this growth include increasing incidences of chronic diseases like renal failure, gastrointestinal disorders, and malnutrition, which require electrolyte replenishment.

Segment-specific Insights

• Amino Acids and Dextrose Solutions: These constitute the largest segment due to their critical role in parenteral nutrition. The rise in hospital-acquired malnutrition and the aging population enhances demand.
• Electrolytes (Magnesium, Potassium, Sodium, Phosphate): The market for electrolyte-specific solutions is expanding rapidly, driven by advancements in critical care and personalized medicine.

Geographic Trends

• North America: Dominates due to high healthcare expenditure, advanced infrastructure, and prevalent chronic conditions.
• Asia-Pacific: Exhibits the fastest growth, fueled by expanding healthcare access, increasing surgical procedures, and rising awareness of electrolyte management.
• Europe: Maintains steady growth with a focus on regulatory compliance and innovation in formulation stability.

Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and Hikma Pharmaceuticals, investing heavily in R&D to develop stable, customizable solutions with improved safety profiles. M&A activity and strategic alliances are prevalent to expand manufacturing capacity and distribution reach.

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Market Projection and Future Outlook

Growth Drivers

• Aging Population & Rising Chronic Diseases: Accelerate demand for tailored nutritional and electrolyte solutions.
• Advances in Parenteral Nutrition: Development of syndrome-specific formulations and combination therapies.
• Regulatory Support: Streamlined approval processes and initiatives for manufacturing quality improvements bolster product pipelines.

Potential Challenges

• Supply Chain Disruptions: Especially for raw materials and active pharmaceutical ingredients (APIs) during geopolitical or pandemics.
• Regulatory Stringency: Increased scrutiny on safety, quality, and stability standards.
• Cost Pressures: Pricing dynamics may influence innovation investment.

Emerging Trends

• Personalized IV Therapy: Integration of biomarkers to customize electrolyte formulations.
• Stability & Compatibility Enhancements: Technology improvements in formulation stability extend shelf-life and compatibility with various infusion systems.
• Sustainability Initiatives: Focus on eco-friendly manufacturing and packaging to meet environmental regulations.

Forecast Summary

The electrolyte and amino acid solution market is poised to reach approximately USD 12.5 billion by 2030, driven by technological innovation, aging demographics, and rising disease burdens. Compound annual growth is projected at around 6%, outperforming the broader IV therapy market.

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Regulatory and Industry Implications

Regulatory bodies like the FDA, EMA, and PMDA continue to emphasize rigorous safety data, manufacturing quality, and evidence-based labeling. Companies investing in novel formulations, stability profiles, or combination products should anticipate a proactive regulatory environment that rewards innovation but necessitates comprehensive documentation.

The market’s future hinges on navigating these evolving regulations strategically, including leveraging accelerated approval pathways for breakthrough therapies and addressing unmet clinical needs.

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Key Takeaways

• Clinical Outlook: Ongoing trials focus on optimizing electrolyte formulations and infusion protocols, emphasizing safety, stability, and tailored patient care.
• Market Growth: The IV electrolyte supplement market is projected to grow at ~6% CAGR through 2030, driven by demographic trends and clinical innovations.
• Regional Dynamics: North America leads, but Asia-Pacific presents rapid growth opportunities due to expanding healthcare infrastructure.
• Competitive Landscape: Innovation, strategic alliances, and regulatory compliance will define market leaders.
• Future Focus: Emphasis on personalized IV therapies, stability improvements, and eco-friendly manufacturing will shape product development.

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FAQs

1. What factors are driving demand for IV electrolyte solutions?
Demographic shifts such as aging populations, increasing prevalence of chronic diseases, and advancements in critical care are primary drivers. The need for customized parenteral nutrition and electrolyte repletion in hospitals sustains demand growth.

2. How are ongoing clinical trials impacting the market?
They inform formulation improvements, safety protocols, and dosing strategies, leading to better clinical outcomes. Positive trial results can accelerate regulatory approvals and market entry, fueling expansion.

3. What regulatory considerations are crucial for new electrolyte formulations?
Regulatory agencies require comprehensive safety and stability data, demonstrating product compatibility, toxicity profiles, and manufacturing quality. Innovations in stability and conjugation with other molecules may necessitate dedicated studies.

4. Which regions show the highest growth potential for electrolyte solutions?
While North America remains dominant, Asia-Pacific is experiencing rapid growth, fueled by expanding healthcare services and increased surgical and nutritional needs.

5. What future innovations are anticipated in IV electrolyte therapy?
Advancements include personalized formulations based on genetic or metabolic markers, longer shelf-life stabilized solutions, and environmentally sustainable manufacturing practices.

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References

[1] ClinicalTrials.gov, "Trials evaluating amino acids and dextrose in parenteral nutrition," accessed 2023.
[2] Regulatory Focus, "Electrolyte Solutions Safety and Compatibility," 2022.
[3] MarketsandMarkets, "IV Solutions Market by Ingredient, Application, and Region," 2022.