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	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.
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.

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	Bayer	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	NEMC	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.

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

Condition Name

Condition Name for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention	Trials
Metabolic Acidosis	16
Acute Kidney Injury	16
Contrast Induced Nephropathy	15
Chronic Kidney Disease	14

Condition MeSH

Condition MeSH for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	30
Renal Insufficiency, Chronic	23
Renal Insufficiency	20

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

Trials by Country

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Trials by Country for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location	Trials
United States	196
Italy	19
Brazil	14
Australia	13
Canada	13

Trials by US State

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Trials by US State for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location	Trials
Texas	13
California	13
Pennsylvania	11
North Carolina	11
New York	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
Phase 4	72
Phase 3	40
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	138
Recruiting	31
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
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	5

Sponsor Type

Sponsor Type for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Sponsor	Trials
Other	316
Industry	66
NIH	12

Magnesium Chloride, Sodium Bicarbonate, and Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Magnesium chloride, sodium bicarbonate, and sodium chloride are compounds with diverse applications across various industries, including healthcare, construction, and consumer goods. This article delves into the current state of clinical trials, market analysis, and future projections for these compounds.

Clinical Trials: Magnesium Chloride

Quality of Life in Fibromyalgia Patients

A pilot study conducted by the Mayo Clinic aims to investigate the effect of transdermal magnesium chloride on the quality of life in patients with fibromyalgia. This study involves 40 women who apply a topical solution of magnesium chloride on their extremities three times daily for 28 consecutive days. The study assesses quality of life through questionnaires administered at baseline, at 2 weeks, and at the end of the study[1].

Magnesium Replacement or Supplementation

Another study by the Mayo Clinic explores the impact of a magnesium-rich diet combined with topical magnesium lotion on maintaining or increasing magnesium blood levels in patients. This research focuses on patients with low magnesium levels, particularly those with lymphoma, and evaluates the side effects and quality of life associated with different forms of magnesium supplementation[4].

Market Analysis: Magnesium Chloride

Global Market Size and Growth

The global magnesium chloride market was valued at USD 706.0 million in 2024 and is projected to reach USD 1,225.4 million by 2035, growing at a CAGR of 5.1% during this period. The market is driven by increasing demand in de-icing, water treatment, agriculture, and construction sectors. Magnesium chloride's eco-friendly attributes and effectiveness at lower temperatures make it a preferred choice over traditional de-icing agents like sodium chloride[2].

Key Applications

• De-icing: Magnesium chloride is favored for its ability to function at lower temperatures with minimal corrosive effects on infrastructure.
• Water Treatment: It is used in water treatment and desalination processes.
• Agriculture: Magnesium chloride contributes to soil improvement and is used in dust suppression.
• Construction: It is used as an additive in cement production, enhancing workability and reducing the carbon footprint of cement[2][5].

Market Projections: Magnesium Chloride

Regional Growth

The market is expected to grow significantly in regions with harsh winters, such as North America and Europe, due to its de-icing applications. Additionally, rising economies in the Asia-Pacific region, driven by industrialization and government incentives for clean energy projects, will boost demand in construction and agriculture sectors[2].

Technological Advancements

Technological advancements, including magnesium-based energy storage systems and green technologies, will further drive the demand for magnesium chloride. The focus on environmental sustainability and the adoption of renewable energy sources will continue to fuel market growth[2].

Clinical Trials and Market Analysis: Sodium Bicarbonate

Pharmaceutical Applications

Sodium bicarbonate is widely used in the pharmaceutical industry, particularly as an active pharmaceutical ingredient (API) for treating metabolic acidosis, hemodialysis, cardiac arrest, and uncontrolled diabetes. A study by the University of Liverpool and the Karolinska Institute found that adding pharmaceutical-grade sodium bicarbonate to oxytocin increased the chances of natural vaginal delivery by 17%[3].

Market Size and Growth

The global pharmaceutical-grade sodium bicarbonate market is expected to reach USD 387.7 million by 2034, growing at a CAGR of 3.5%. The market is driven by increasing consumption in the pharmaceutical industry and the growing geriatric population. China's market is expected to grow at a CAGR of 3.9%, while the U.S. market is projected to rise at a CAGR of 2%[3].

Product Innovations

Companies like Nephron Pharmaceuticals Corporation and Akums Drugs & Pharmaceuticals Ltd are launching new products, such as sodium bicarbonate injections and chewable tablets, which are contributing to market growth. The coarse segment of pharmaceutical-grade sodium bicarbonate is expected to hold a market share of 78.2% in 2024[3].

Market Projections: Sodium Bicarbonate

Geographical Expansion

The market is expanding geographically to cater to a larger consumer base. Government policies, foreign direct investments, and healthcare infrastructure development programs are set to drive revenue growth. E-commerce strategies are also crucial for leading companies to enhance customer experience and grow their reach[3].

Competitive Landscape

The global pharmaceutical-grade sodium bicarbonate market is dominated by leading manufacturers like Dr. Paul Lohmann GmbH KG and GHCL Limited. These companies are focusing on new product launches, collaborations, mergers, acquisitions, and joint ventures to distribute their products in healthcare institutions[3].

Sodium Chloride: Market Overview

Traditional Applications

Sodium chloride, commonly known as table salt, has traditional applications in food preservation, pharmaceuticals, and as a de-icing agent. However, its use as a de-icing agent is being gradually replaced by magnesium chloride due to the latter's effectiveness at lower temperatures and reduced corrosive effects on infrastructure[2].

Market Impact

The shift towards magnesium chloride in de-icing and other industrial applications has somewhat reduced the demand for sodium chloride in these sectors. However, sodium chloride remains a staple in food and pharmaceutical industries, ensuring a stable market presence.

Key Takeaways

• Magnesium Chloride: The global market is expected to grow at a CAGR of 5.1% from 2025 to 2035, driven by its eco-friendly attributes and diverse applications.
• Sodium Bicarbonate: The pharmaceutical-grade market is projected to reach USD 387.7 million by 2034, growing at a CAGR of 3.5%, driven by increasing pharmaceutical applications and a growing geriatric population.
• Sodium Chloride: While its use in de-icing is declining in favor of magnesium chloride, it remains significant in food and pharmaceutical industries.

FAQs

What are the primary applications of magnesium chloride?

Magnesium chloride is primarily used in de-icing, water treatment, agriculture, and construction. It is favored for its effectiveness at lower temperatures and minimal corrosive effects.

How is the global magnesium chloride market expected to grow?

The global magnesium chloride market is expected to reach USD 1,225.4 million by 2035, growing at a CAGR of 5.1% from 2025 to 2035.

What drives the demand for pharmaceutical-grade sodium bicarbonate?

The demand is driven by increasing consumption in the pharmaceutical industry, particularly for treating metabolic acidosis, hemodialysis, and cardiac arrest, as well as a growing geriatric population.

Why is magnesium chloride preferred over sodium chloride for de-icing?

Magnesium chloride is preferred due to its effectiveness at lower temperatures and its minimal corrosive effects on infrastructure, making it a greener alternative.

What are the key regions driving the growth of the magnesium chloride market?

The growth is driven by regions with harsh winters like North America and Europe, as well as rising economies in the Asia-Pacific region.

Sources

1. Mayo Clinic: "Effect of Transdermal Magnesium Chloride on Quality of Life in Patients with Fibromyalgia"[1].
2. Future Market Insights: "Magnesium Chloride Market Industry Report & Analysis 2025"[2].
3. GlobeNewswire: "Rising Usage of Sodium Bicarbonate in Cleansing Solutions and Systemic Alkalizer to Surge Pharma Grade Sodium Bicarbonate Market at 3.5% CAGR by 2034"[3].
4. Mayo Clinic: "Dietary and Topical Magnesium Replacement or Supplementation in Patients with Low Magnesium Levels"[4].
5. Grand View Research: "Magnesium Chloride Market Size And Share Report, 2030"[5].