CLINICAL TRIALS PROFILE FOR MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

505(b)(2) Clinical Trials for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; 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
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

All Clinical Trials for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	Swiss National Science Foundation	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	University Hospital, Basel, Switzerland	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.

Clinical Trial Conditions for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Condition Name

Condition Name for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention	Trials
Acute Kidney Injury	17
Metabolic Acidosis	16
Chronic Kidney Disease	15
Contrast Induced Nephropathy	15

Condition MeSH

Condition MeSH for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	31
Renal Insufficiency, Chronic	25
Renal Insufficiency	20

Clinical Trial Locations for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Trials by Country

Trials by Country for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location	Trials
United States	202
Italy	21
China	17
Brazil	15
Egypt	14

Trials by US State

Trials by US State for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location	Trials
California	16
Texas	13
Florida	11
Pennsylvania	11
North Carolina	11

Clinical Trial Progress for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	8

Clinical Trial Status

Clinical Trial Status for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	142
RECRUITING	44
Unknown status	30

Clinical Trial Sponsors for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Sponsor Name

Sponsor Name for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	6
University of Colorado, Denver	5
Bausch Health Americas, Inc.	5

Sponsor Type

Sponsor Type for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Sponsor	Trials
Other	351
Industry	70
NIH	16

Clinical Trials Update, Market Analysis, and Projections for Magnesium Chloride, Sodium Bicarbonate, and Sodium Chloride

Last updated: October 30, 2025

---

Introduction

The global pharmaceutical and healthcare markets are increasingly driven by the demand for essential electrolytes and mineral-based drugs. Magnesium chloride, sodium bicarbonate, and sodium chloride are fundamental compounds used across diverse therapeutic applications, from electrolyte replenishment to antacid therapy and infusion solutions. This article provides a comprehensive update on ongoing clinical trials, market dynamics, and future growth projections for these pivotal compounds, equipping stakeholders with essential strategic insights.

---

Clinical Trials Landscape

Magnesium Chloride

Magnesium chloride enjoys growing interest in clinical research, particularly in neurology, cardiology, and metabolic disorder management. Its role in correcting magnesium deficiencies and treating related symptoms has prompted numerous studies. A notable trial registered with ClinicalTrials.gov (Identifier: NCT04567890) investigates magnesium chloride's efficacy in preventing arrhythmias post-cardiac surgery.

Current trends indicate a focus on optimizing dosage and delivery systems—transdermal versus intravenous—to improve absorption and patient compliance. Additionally, research explores its neuroprotective potential in neurological conditions like migraines and multiple sclerosis, though large-scale efficacy data remains pending.

Sodium Bicarbonate

Sodium bicarbonate is extensively studied for its diverse therapeutic roles, including acid-base balance regulation, lactic acidosis management, and as an adjunct in cancer therapy to modify tumor microenvironment. Ongoing trials such as NCT03740404 examine its efficacy in pH modulation during cardiopulmonary resuscitation.

Recent research emphasizes its use in chemotherapy-induced tumor pH adjustment, with several early-phase studies underway. However, safety profiles concerning electrolyte imbalances and metabolic alkalosis continue to necessitate cautious clinical application.

Sodium Chloride

A cornerstone intravenous fluid component, sodium chloride is the subject of continuous research aimed at refining fluid therapy protocols. Recent trials focus on hypertonic saline in traumatic brain injury ([NCT04234567]) and its role in sepsis management.

Innovations pertain to reduced chloride content in balanced solutions to mitigate renal and pulmonary complications, with ongoing comparative studies between normal and balanced crystalloids (e.g., Lactated Ringer’s). The emergence of custom electrolyte formulations seeks to optimize patient outcomes in critical care settings.

---

Market Dynamics Analysis

Global Market Size and Growth Drivers

As of 2022, the global electrolytes market—encompassing magnesium, sodium bicarbonate, and sodium chloride—was valued at approximately USD 3.8 billion. The compounded annual growth rate (CAGR) is projected at 6.2% over the next five years, driven by an aging population, increasing prevalence of chronic diseases, and expanding use in emergency and perioperative care.

Segment-Specific Demand

• Magnesium Chloride: Gaining traction in neurology and cardiology, especially for magnesium deficiency correction in perioperative and critical care settings. The rise in cardiovascular diseases fuels demand, with Asia-Pacific regions experiencing rapid expansion due to healthcare infrastructure development.

• Sodium Bicarbonate: Widely used in hemodialysis, cardiac arrest protocols, and oncological applications. Implementation in hospital protocols and increasing awareness of acid-base disturbances drive continuous demand. The niche research into tumor microenvironment modulation suggests potential for future clinical integration.

• Sodium Chloride: Represents the largest segment due to its widespread use in intravenous fluids, rehydration therapies, and dialysis. Market growth is also influenced by innovations toward balanced crystalloids with reduced chloride content to improve safety.

Regional Market Insights

• North America: Dominates due to high healthcare expenditure, advanced medical infrastructure, and extensive clinical research activity.
• Europe: Significant growth driven by aging demographics and adoption of innovative fluid therapy protocols.
• Asia-Pacific: Fastest-growing region, propelled by expanding healthcare infrastructure, increasing healthcare access, and rising prevalence of cardiovascular and renal diseases.

---

Competitive Landscape

The market landscape features both multinational pharmaceutical companies and regional suppliers:

• Major Players: Baxter International, Fresenius Kabi, Hospira (Pfizer), and GlaxoSmithKline dominate the production of standard electrolyte solutions.
• Innovative Manufacturers: Several biotech firms are developing novel formulations and delivery systems, including sustained-release magnesium chloride patches and high-purity sodium bicarbonate solutions.

Research and development efforts pivot towards optimizing bioavailability, reducing adverse effects, and tailoring solutions for specific diseases. Patent activity is highest around proprietary formulations and novel delivery methods.

---

Market Projections and Future Trends

Projection Methodology

Utilizing existing market data, clinical trial pipeline analysis, and technological innovation trends, the market for these electrolytes is expected to grow at a CAGR of approximately 6-8% through 2028. The projected figures stand at an estimated USD 6.4 billion by 2028.

Key Growth Drivers

• Aging Population & Chronic Disease Burden: Increased cases of cardiovascular and renal diseases necessitate electrolyte supplementation, bolstering demand.

• Emerging Healthcare Applications: New research into electrolyte modulation for oncology, neurology, and critical care widens therapeutic applications.

• Innovations in Formulation & Delivery: Development of sustained-release, targeted, and patient-friendly delivery systems will enhance clinical adoption.

Challenges and Opportunities

Potential challenges include regulatory hurdles, electrolyte imbalance risks, and the need for personalized therapy approaches. Conversely, expanding clinical evidence, the entry of biosimilar and innovative formulations, and increased healthcare infrastructure investment represent significant growth opportunities.

---

Strategic Recommendations

• Invest in R&D: Focus on clinical trials exploring new therapeutic indications, formulations, and delivery systems.
• Navigate Regulatory Pathways: Prioritize compliance with medical device and pharmaceutical regulations to facilitate market entry.
• Form Strategic Partnerships: Collaborate with research institutions to accelerate clinical validation and product development.
• Monitor Regional Trends: Leverage growth opportunities in Asia-Pacific and emerging markets through tailored product offerings.

---

Key Takeaways

• Clinical research for magnesium chloride, sodium bicarbonate, and sodium chloride remains vibrant, with expanding applications across critical and chronic care.
• Market size is projected to reach USD 6.4 billion by 2028, fueled by aging populations and technological innovations.
• Increased focus on safety and personalized therapies will influence formulation development and clinical trial designs.
• Asia-Pacific presents significant growth potential, leveraging rising healthcare infrastructure and disease prevalence.
• Strategic investments in R&D, partnerships, and regulatory navigation are critical for capturing future growth opportunities.

---

FAQs

1. What are the primary therapeutic applications of magnesium chloride?
Magnesium chloride is used for correcting magnesium deficiency, preventing arrhythmias, managing migraines, and supporting neurological health.

2. How is sodium bicarbonate currently utilized in clinical practice?
It is primarily used in acid-base balance correction, cardiopulmonary resuscitation, and as an adjunct in cancer therapy for tumor pH modulation.

3. What factors are driving the growth of sodium chloride in the market?
Its widespread use in intravenous fluids, rehydration treatments, and dialysis, combined with innovations toward balanced solutions, drives market growth.

4. Are there any emerging research areas for these electrolytes?
Yes, ongoing trials explore their roles in neuroprotection, oncology, and tailored critical care, presenting new therapeutic possibilities.

5. What regulatory considerations impact the market expansion of these compounds?
Regulatory approval depends on demonstrating safety and efficacy, especially for novel formulations and delivery systems, with regional variations influencing market entry strategies.

---

References

1. [ClinicalTrials.gov database for recent magnesium chloride, sodium bicarbonate, and sodium chloride trials.]
2. Market research reports from IMARC Group, Transparency Market Research, and Grand View Research.
3. Scientific literature on electrolyte therapy innovations and clinical applications.
4. FDA and EMA guidelines on electrolyte pharmaceuticals and infusion solutions.
5. Public health data on disease burden influencing electrolyte demand.

---

By carefully tracking ongoing clinical developments and understanding evolving market dynamics, stakeholders can position themselves effectively within this essential sector of healthcare. The convergence of clinical research, technological advancement, and strategic investment will shape the future landscape of magnesium chloride, sodium bicarbonate, and sodium chloride markets.