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

505(b)(2) Clinical Trials for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

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 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

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 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

Condition Name

Condition Name for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Intervention	Trials
Healthy	3
Diabetes Mellitus, Type 2	2
Respiratory Distress Syndrome, Adult	2
Diabetic Ketoacidosis	2

Condition MeSH

Condition MeSH for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	6
Hypercalciuria	3
Calculi	3

Clinical Trial Locations for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

Trials by Country

Trials by Country for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Location	Trials
United States	29
Canada	3
Switzerland	3
Egypt	3
United Kingdom	3

Trials by US State

Trials by US State for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Location	Trials
California	3
Minnesota	3
Maryland	3
Pennsylvania	2
Massachusetts	2

Clinical Trial Progress for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

Clinical Trial Phase

Clinical Trial Phase for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	7
Recruiting	6

Clinical Trial Sponsors for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

Sponsor Name

Sponsor Name for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Sponsor	Trials
University of Minnesota	3
National Institutes of Health (NIH)	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2

Sponsor Type

Sponsor Type for DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Sponsor	Trials
Other	68
Industry	11
NIH	8

Clinical Trials Update, Market Analysis, and Projections for Intravenous Electrolytes: Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate (Dibasic), and Sodium Acetate

Last updated: October 31, 2025

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Introduction

Intravenous (IV) electrolyte solutions are fundamental in clinical practice, used to manage dehydration, electrolyte imbalances, and metabolic disturbances. The core compounds—Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate (Dibasic), and Sodium Acetate—serve as critical components in various formulations worldwide. This report updates on recent clinical trials, analyzes market dynamics, and projects future trends for these key IV electrolytes, providing valuable insights for industry stakeholders.

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Clinical Trials Landscape

Overview of Current and Pending Trials

Recent years have witnessed a surge in clinical investigations targeting IV electrolytes, driven by emerging data on efficacy, safety, and novel formulations. Major clinical trial registries such as ClinicalTrials.gov list numerous ongoing and completed studies—particularly focusing on magnesium and potassium-based solutions.

Magnesium Chloride

Magnesium chloride (MgCl_2) has gained prominence in trials assessing its role in managing hypomagnesemia, cardiac arrhythmias, and neurological conditions. Notably, a phase III trial evaluating magnesium chloride's efficacy in preventing contrast-induced nephropathy has shown promising results, suggesting potential forexpanded indications. Recent research also focuses on magnesium's neuroprotective properties in traumatic brain injury, with preliminary data indicating benefits in reducing neuroinflammation.

Potassium Chloride

Potassium chloride (KCl) remains a staple in treating hypokalemia. Novel formulations with extended-release properties are in exploratory phases, aiming to reduce the risk of hyperkalemia. Studies evaluating KCl's role in combination therapy for heart failure and hypertension are underway, seeking to optimize dosing protocols.

Potassium Phosphate (Dibasic)

Potassium phosphate (K_3PO_4, dibasic) is primarily used in repletion of phosphatemia and managing metabolic disturbances. Clinical trials are exploring its utility in critically ill patients with complex electrolyte imbalances. Recent investigations examine its administration alongside other electrolytes to minimize cardiac and neuromuscular complications.

Sodium Acetate

Sodium acetate, as an alternative to sodium bicarbonate, is under clinical evaluation for its buffering capacity in metabolic acidosis, especially in septic shock and renal failure. Trials demonstrated potential benefits in hemodynamic stability and acid-base correction, prompting further phase II/III studies.

Dextrose Solutions

Dextrose-based solutions, predominantly Dextrose 5% (D5), are ongoing in trials assessing their role in caloric support, diabetic ketoacidosis management, and as carriers for drug delivery. Recent studies focus on glucose control in critical care settings, with some exploring novel formulations to mitigate hyperglycemia risks.

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Market Analysis

Global Market Size and Growth

The global IV electrolyte solutions market was valued at approximately USD 4.2 billion in 2022, with a Compound Annual Growth Rate (CAGR) projected at around 6.2% over the next five years. The growth is driven by increasing incidences of chronic diseases, aging populations, and expanding healthcare infrastructure.

Regional Market Dynamics

• North America: Dominates the market owing to high healthcare expenditure, advanced medical infrastructure, and growing research activities. U.S. accounted for nearly 45% of global sales in 2022.
• Europe: The aging population and rising prevalence of cardiovascular and renal diseases fuel demand.
• Asia-Pacific: Expected to exhibit the highest CAGR (~8%) due to increasing healthcare access, new manufacturing facilities, and rising disposable incomes.

Key Market Players

Major players include Baxter International, Fresenius Kabi, B. Braun Melsungen AG, and Novartis AG. These companies focus on expanding their product portfolios through innovation and strategic collaborations.

Product Segmentation

• Dextrose Solutions: Dominates due to broad applications in nutritional support.
• Electrolyte Solutions (MgCl_2, KCl, K_3PO_4): Growing demand in hospital settings for electrolyte repletion and management.
• Sodium Acetate: Niche but expanding use in critical care settings.

Regulatory and Manufacturing Trends

Stringent regulations in the U.S. (FDA), Europe (EMA), and Asia influence product formulations, quality standards, and approval timelines. Manufacturing shifts toward more sustainable and scalable processes are observed, with companies investing in local production to mitigate supply chain disruptions.

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Market Projections

Future Trends and Opportunities

• Emergence of Novel Formulations: Liposomal and nanoparticle-based electrolyte delivery systems are under research, promising targeted therapy with improved safety profiles.
• Personalized Medicine: Increased focus on tailoring electrolyte therapy based on genetic and metabolic profiles.
• Digital Health Integration: Use of continuous electrolyte monitoring devices could revolutionize IV therapy precision.
• Regulatory Pathways: Accelerated approval pathways, especially for drugs with proven clinical benefit, are likely to expedite market entry for innovative electrolytes.

Impact of COVID-19

The pandemic underscored the essential nature of IV electrolyte solutions, seeing increased demand for dehydration management and metabolic stabilization in critical COVID-19 cases. Moving forward, supply chain resilience and stockpiling are expected to maintain elevated market levels.

Market Forecast (2023–2030)

The IV electrolyte solutions market is projected to reach USD 6.8 billion by 2030, with magnesium and potassium-based products leading growth segments. The expansion will be driven by clinical trial outcomes demonstrating improved therapeutic efficacy, safety enhancements, and strategic commercial investments.

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Key Takeaways

• Clinical trials are focusing on expanding the utility and safety profile of IV electrolytes, especially magnesium chloride and potassium formulations. Positive trial results could unlock new indications and stimulate market growth.
• Market growth is driven by aging populations, increasing chronic disease prevalence, and expanding healthcare infrastructure, particularly in Asia-Pacific.
• Innovative formulations and personalized electrolyte therapy will be key differentiators for market players.
• Regulatory landscapes and supply chain adaptations will significantly influence product availability and uptake.
• Post-pandemic recovery and ongoing technological advances will sustain an optimistic outlook for this essential drug segment.

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FAQs

Q1: What are the anticipated therapeutic advancements in IV electrolyte solutions?
A1: Developments include targeted delivery systems, extended-release formulations, and personalized electrolyte replacement strategies optimized through real-time monitoring devices.

Q2: How are ongoing clinical trials influencing market growth?
A2: Positive clinical trial outcomes can lead to expanded indications, improved safety profiles, and increased clinician confidence, thereby boosting adoption and sales.

Q3: Which geographical region is expected to see the fastest growth in IV electrolyte markets?
A3: Asia-Pacific is projected to grow at the highest CAGR due to expanding healthcare infrastructure and rising demand in developing economies.

Q4: Are there emerging competitors in the IV electrolyte market?
A4: While established players dominate, startups focusing on innovative drug delivery platforms and biosynthesis methods are emerging, poised to disrupt traditional markets.

Q5: What regulatory challenges face the commercialization of new electrolyte formulations?
A5: Ensuring compliance with stringent safety, efficacy, and manufacturing standards set by agencies like the FDA and EMA can delay or complicate approval processes but are necessary for market access.

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References

[1] MarketsandMarkets, "Intravenous (IV) Solutions Market," 2022.
[2] ClinicalTrials.gov, Database of ongoing and completed electrolyte-assessment trials, 2023.
[3] Grand View Research, "Global Electrolyte Solutions Market Analysis," 2022.
[4] FDA and EMA Regulatory Guidelines, 2023.