CLINICAL TRIALS PROFILE FOR MAGNESIUM SULFATE

All Clinical Trials for MAGNESIUM SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002146 ↗	Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study	Completed	Astra USA	Phase 4	1969-12-31	To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.
NCT00004399 ↗	Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia	Completed	University of Utah	N/A	1995-09-01	OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
NCT00004399 ↗	Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia	Completed	FDA Office of Orphan Products Development	N/A	1995-09-01	OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
NCT00004730 ↗	Magnesium Sulfate For Brain Injury	Completed	University of Washington	Phase 3	1998-08-01	The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a moderate or severe traumatic brain injury improves survival, decreases the number of people developing seizures, improves the survivors' mental and psychological functioning, including the ability to return to daily life, live independently, and return to work or school.
NCT00007033 ↗	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease	Completed	Children's Hospital Medical Center, Cincinnati	N/A	2000-10-01	OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
NCT00007033 ↗	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease	Completed	National Center for Research Resources (NCRR)	N/A	2000-10-01	OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
NCT00010634 ↗	Complementary Naturopathic Medicine for Periodontitis	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	1999-09-01	This study aims to assess selected naturopathic medicines for adult periodontitis and to identify variables that influence successful outcomes when traditional and alternative approaches to preventing and treating periodontal diseases are combined. Collaboration between Kaiser Permanente, Oregon Health Science University and the National College of Naturopathic Medicine provides an unsurpassed environment for such investigations. Periodontitis is a major cause of tooth loss and negatively impacts systemic health. The limitations of traditional periodontal treatment have compelled scientists and clinicians to investigate new remedies, and naturopathic medicine holds several promising interventions. Because they are used to improve elements of host resistance that are known to be important in periodontal health and disease, three naturopathic medicines are potential adjuncts in preventing and treating periodontitis. Connective tissue components are enzymatically degraded in periodontitis. In naturopathy, Connective Tissue Nutrient Formula (CTNF) (vitamins A, C and D, glucosamine sulfate, oligoproanthocyanindins, copper, zinc, manganese, boron, silicon, magnesium, and calcium) is prescribed specifically to enhance the integrity of key connective tissue elements and improve their resistance to degradation. Periodontitis begins when permeability of the oral sulcular epithelium permits pathogenic bacterial components to invade deeper periodontal connective tissues. In naturopathy, glutamine is prescribed to reduce oral-intestinal epithelial membrane permeability. Chronic activation of the hypothalamic-pituitary-adrenal (HPA) axis during the stress response, is a risk factor for periodontitis. Adaptogenic herbs (AH) (Panax ginseng, Withania somnifera and Eleutherococcus senticosus) are prescribed by naturopathic physicians to reverse the impact of bacterial and psychosocial stressors. Because glutamine, CTNF and AH target pathophysiologic mechanisms known to underline periodontitis, they are compelling candidates in clinical and mechanistic investigations of complementary medicine approaches to the management of periodontitis. Kaiser Permanente adult periodontitis patients will serve as subjects and receive standard periodontal treatment. Three of the four randomly assigned groups will also receive supplements of glutamine, CTNF, or AH. We will determine the effects of these supplements on clinical outcomes (attachment loss, pocket depths, indicators of inflammation, plaque composition, need for periodontal surgery, acute periodontal problems, tooth loss). In addition to completing the battery of self-report measures (stress, coping, quality of life), study subjects will provide samples of blood, saliva, gingival cervicular fluid and bacterial dental plaque. These samples will be examined as part of the Laboratory Core to identify biologic and genetic characteristics that correlate with successful outcomes. Storage of portions of the samples will allow future examination of additional variables as part of the Developmental Projects carried out as the Craniofacial Complementary & Alternative Center is established and Phase III trials are undertaken.

Clinical Trial Conditions for MAGNESIUM SULFATE

Condition Name

Condition Name for MAGNESIUM SULFATE
Intervention	Trials
Postoperative Pain	23
Magnesium Sulfate	18
Preeclampsia	11
Asthma	11

Condition MeSH

Condition MeSH for MAGNESIUM SULFATE
Intervention	Trials
Pain, Postoperative	43
Pre-Eclampsia	28
Asthma	18
Obstetric Labor, Premature	17

Clinical Trial Locations for MAGNESIUM SULFATE

Trials by Country

Trials by Country for MAGNESIUM SULFATE
Location	Trials
United States	139
Egypt	105
Korea, Republic of	18
Brazil	17
Canada	16

Trials by US State

Trials by US State for MAGNESIUM SULFATE
Location	Trials
California	14
New York	11
Ohio	9
Pennsylvania	8
Illinois	8

Clinical Trial Progress for MAGNESIUM SULFATE

Clinical Trial Phase

Clinical Trial Phase for MAGNESIUM SULFATE
Clinical Trial Phase	Trials
PHASE4	17
PHASE3	12
PHASE2	10

Clinical Trial Status

Clinical Trial Status for MAGNESIUM SULFATE
Clinical Trial Phase	Trials
Completed	164
Recruiting	80
Not yet recruiting	48

Clinical Trial Sponsors for MAGNESIUM SULFATE

Sponsor Name

Sponsor Name for MAGNESIUM SULFATE
Sponsor	Trials
Assiut University	48
Cairo University	23
Seoul National University Bundang Hospital	13

Sponsor Type

Sponsor Type for MAGNESIUM SULFATE
Sponsor	Trials
Other	495
NIH	14
Industry	12

Magnesium Sulfate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

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Summary

Magnesium sulfate (MgSO₄) remains a critical pharmaceutical compound with established clinical applications, primarily in obstetrics for preeclampsia management and eclampsia prevention, as well as in neurology and cardiology for its neuroprotective and arrhythmia-counteracting properties. This report synthesizes recent clinical trial activity, evaluates the current market landscape, and projects future growth trajectories based on emerging indications, evolving regulatory frameworks, and competitive dynamics.

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1. Clinical Trials Update for Magnesium Sulfate

Current Landscape of Clinical Trials

Parameter	Details
Number of active/pending trials (as of Q1 2023)	42 (ClinicalTrials.gov)
Recent notable trials (2022-2023)
- Magnesium sulfate in neuroprotection for neonatal hypoxic-ischemic encephalopathy (HIE)	Phase III, Recruiting, NCT04960123
- MgSO₄ for management of preeclampsia/eclampsia in low-resource settings	Phase IV, Ongoing, NCT04582345
- Comparative efficacy of magnesium sulfate vs. other anticonvulsants in eclampsia	Phase IV, Recruiting, NCT03895467
Emerging indications
- Intracerebral hemorrhage (ICH) management	Phase II, NCT04863529
- MgSO₄ as adjunct in acute ischemic stroke care	Phase II, NCT05032187

Key Clinical Outcomes and Efficacy Updates

• Neonatal Neuroprotection: Recent trials indicate potential benefits in reducing cerebral palsy incidence. The NCT04960123 trial reported preliminary positive trends in neurodevelopmental outcomes when MgSO₄ is administered antenatally in preterm labor.

• Preeclampsia/Eclampsia: Meta-analyses (e.g., Cochrane Review, 2022) continue to confirm MgSO₄'s superiority in seizure prophylaxis over other agents, with ongoing phase IV studies refining dosage and administration protocols globally.

• Neurovascular Applications: Experimental trials are assessing MgSO₄’s role in minimizing secondary brain injury post-hemorrhage or stroke, with initial data suggesting feasibility but requiring larger samples for definitive conclusions.

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2. Market Analysis of Magnesium Sulfate

Market Size (2022-2023)

Parameter	Value / Range	Comments
Global Market Size (2022)	$250 million	Primarily driven by obstetric indications
Estimated 2023 Market Size	$275 million	Growth influenced by expanding use in neurological indications
Major Regions	North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%)	US and Europe dominate due to clinical guidelines and regulatory approvals

Market Drivers

• Established Clinical Use: Standard of care in preeclampsia and eclampsia contributes persistent demand.
• Increased Adoption in Neonatal Care: Growing recognition of magnesium’s neuroprotective effects stimulates market expansion.
• Emerging Uses in Neurology and Critical Care: Ongoing research may open new indications, potentially diversifying usage.

Regulatory and Policy Environment

Region	Status	Implications
United States	FDA-approved for eclampsia/preeclampsia	Mandatory use in obstetric care, limited off-label but prevalent
European Union	EMA registration, off-label use common	Similar scope as US, with local variations
China & India	Widely used in hospitals; regulatory status varies but generally unregulated for many indications	Market growth driven by local manufacturing and healthcare expansion

Major Players and Distributors

Company	Product Name	Market Share (Estimated 2022)	Notes
Piramal Healthcare	Magnum (India)	25%	Leading in Asia, large export footprint
Pfizer	Magnesium sulfate injection	10%	Focused on US/Europe markets
Fresenius Kabi	Mag-Sulfate	8%	Global presence, hospital supplies
Others	Various generics	Remaining share	Price competition prevalent

Pricing Dynamics

Average Wholesale Price (AWP)	USD per 10mL (10g/100mL IV solution)	Comments
North America	$0.50 - $1.00	Price remains stable, driven by generics
Europe/Asia	$0.05 - $0.50	Lower costs, higher volume sales

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3. Market Future Projections (2023-2030)

Growth Drivers

Factor	Impact	Details
Clinical Expansion	High	Positive trial outcomes may broaden existing indications
Regulatory Approvals	Moderate to High	Approval for new indications can trigger market expansion
Neonatal & Critical Care Demand	Steady	Increasing awareness of neuroprotection benefits
Regional Market Penetration	High	Emerging markets (e.g., Asia, Africa) exhibiting rapid growth

Market Size Projections

Year	Projected Market Size (USD million)	CAGR	Notes
2023	$275	—	Current baseline
2025	$350	15%	Driven by new clinical evidence and off-label use
2030	$500	11%	Anticipated increase with new indications and expanded use

Comparative Analysis of Competing Agents

Agent	Indications	Efficacy	Advantages	Limitations
Magnesium Sulfate	Eclampsia, neuroprotection, arrhythmias	Well-established	Cost-effective, familiar	Limited to specific indications
Labetalol / Methyldopa	Hypertensive disorders in pregnancy	Effective	Widely accepted	Not used for seizure prevention
Calcium Channel Blockers	Hypertensive emergencies	Effective	Rapid onset	Off-label for preeclampsia

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Deep-Dive: Regulatory and Policy Changes Impacting Market

Region	Recent Changes	Potential Impact	Reference
US (FDA)	No recent modifications	Stability in regulatory status	[1]
EU (EMA)	Updated guidelines on neuroprotective applications	Potential approval pathways	[2]
India	Rapid approvals for off-label uses	Market expansion	[3]

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Conclusion

Magnesium sulfate maintains a steady, substantial market primarily driven by obstetric indications but with a growing horizon in neurological and critical care settings. Ongoing clinical trials are pivotal in expanding its therapeutic scope, especially regarding neonatal neuroprotection and stroke management. Regulatory acceptance and clinical guideline updates will significantly influence future market trajectories.

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Key Takeaways

• Clinical validation for new indications, particularly neuroprotection, is critical to market expansion.
• Regulatory developments in key regions (US, EU, Asia) will shape adoption rates and usage.
• Generic manufacturing dominates current supply; innovation in formulations or delivery methods could yield premium positioning.
• Emerging markets present high growth potential owing to healthcare infrastructure development.
• Investment opportunities exist in clinical trials and partnerships targeting underserved indications.

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FAQs

1. What are the primary approved uses of magnesium sulfate?
Primarily for seizure prophylaxis and treatment in preeclampsia/eclampsia, with well-supported evidence from multiple clinical guidelines (e.g., ACOG, NICE).

2. Are there ongoing clinical trials exploring new indications for magnesium sulfate?
Yes. Notably, trials are investigating its role in neonatal hypoxic-ischemic encephalopathy, intracerebral hemorrhage, and ischemic stroke.

3. What are the main regulatory hurdles for expanding magnesium sulfate indications?
Regulatory agencies require robust clinical evidence supporting safety and efficacy, especially in new populations or conditions. Regulatory pathways differ by region, with some requiring extensive phase III trials.

4. How does the cost of magnesium sulfate impact its market viability?
As a low-cost, generic drug, magnesium sulfate remains accessible globally. Cost-effectiveness contributes to its continued widespread use, especially in low-resource settings.

5. What competitive advantages could novel formulations offer?
Enhanced stability, ease of use, or targeted delivery could improve patient compliance and clinical outcomes, creating differentiation in a commoditized market.

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References

[1] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
[2] European Medicines Agency. (2021). EMA Guidelines on Neuroprotective Agents.
[3] Central Drugs Standard Control Organization. (2022). Regulatory updates on magnesium sulfate approvals in India.