CLINICAL TRIALS PROFILE FOR MAGNESIUM SULFATE IN PLASTIC CONTAINER

All Clinical Trials for MAGNESIUM SULFATE IN PLASTIC CONTAINER

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 IN PLASTIC CONTAINER

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for MAGNESIUM SULFATE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MAGNESIUM SULFATE IN PLASTIC CONTAINER
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 IN PLASTIC CONTAINER
Location	Trials
California	14
New York	11
Ohio	9
Pennsylvania	8
Illinois	8

Clinical Trial Progress for MAGNESIUM SULFATE IN PLASTIC CONTAINER

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for MAGNESIUM SULFATE IN PLASTIC CONTAINER

Sponsor Name

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

Sponsor Type

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

MAGNESIUM SULFATE IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: April 28, 2026

Magnesium Sulfate in Plastic Container: Clinical Trials Update, Market Analysis, and Projections

What clinical evidence exists for magnesium sulfate in plastic containers?

Magnesium sulfate is a well-established, off-patent intravenous and intrapartum therapy. Clinical development in “plastic container” form focuses on formulation performance, stability, compatibility, and administration outcomes rather than new molecular efficacy. Across major regulatory regimes, the key clinical questions are safety and usability in preparation and infusion workflows (precipitation, leachables, particulate matter, container closure integrity, and compatibility with co-administered drugs).

Clinical-trials landscape (practical readout)

• No new, drug-defining phase 3/registrational efficacy trials were found for “magnesium sulfate in plastic container” as a container-specific innovation. The molecule’s efficacy is already supported by extensive historical evidence for obstetric and critical-care indications.
• Active clinical activity is typically indirect: studies of administration techniques, compatibility with infusion sets, particulate monitoring, and container-related performance. These studies are usually framed as pharmacopeial compliance and risk-control rather than new therapeutic claims.

Regulatory and quality expectations drive clinical relevance Clinical trials for magnesium sulfate products in plastic containers are generally downstream of:

• Container closure integrity
• Leachables and extractables controls
• Particulate matter controls
• Stability and compatibility (including with dextrose/saline, common infusion admixtures, and drug-device interactions)

This is why market evolution for plastic-container magnesium sulfate is mostly supply-chain and manufacturing quality, not molecule-level innovation.

---

Which indications anchor demand for magnesium sulfate infusion therapy?

Magnesium sulfate is used across obstetrics and intensive care. The demand base is dominated by:

• Obstetrics: eclampsia prophylaxis and treatment, seizure control in severe preeclampsia.
• Critical care: seizure disorders in selected protocols, torsades de pointes prevention/treatment, and other magnesium replacement indications.

Because these are clinical standard-of-care uses, the container format primarily impacts procurement, nursing workflow, infusion safety, and supply continuity, not clinical adoption.

---

How big is the addressable market for injectable magnesium sulfate, and what portion is plastic-container?

Market sizing for magnesium sulfate injection is dominated by generic supply. Container configuration (plastic vs glass) determines a carve-out, not total therapeutic value.

Practical market segmentation used by purchasers Hospitals and wholesalers typically classify and procure by:

• Dosage form: injection solution
• Packaging: flexible plastic bag vs glass vial
• Concentration and fill size
• Supply reliability and cost per dose
• Device compatibility (infusion pumps, Y-site compatibility requirements)

Plastic-container share drivers

• Reduced breakage risk and improved logistics
• Nursing handling and spillage reduction
• Compatibility with IV workflows
• Often lower shipping and warehousing cost due to packaging efficiency

Projection logic Because the molecule is off-patent, growth is driven by:

• Unit volume growth (birth rates, obstetric prevalence, critical-care utilization)
• Replacement of legacy glass supply with plastic for safety and supply continuity
• Tender-driven switching at health systems when cost and supply are favorable

---

What is the competitive structure in magnesium sulfate injection supplies?

The market is competitive and supply-led:

• Large generic manufacturers in injectable lines supply multiple container formats.
• Contract manufacturing and regional supply constraints influence pricing and availability.
• Tendering often requires strict compliance on particulate, stability, and container integrity testing.

Container-specific competition For plastic-container products, competitors win on:

• Unit cost
• Supply reliability
• Packaging formats (bag sizes, concentrations)
• Meeting formulary requirements tied to infusion safety and admixture compatibility documentation

---

Market outlook: revenue and volume projection for plastic-container magnesium sulfate

A defensible projection must tie container format share to adoption. The standard approach is to model:

1. Base demand for magnesium sulfate injection by indication.
2. Convert to a plastic-container adoption rate by geography and facility type.
3. Apply pricing trends typical for generics (often flat-to-declining in real terms with intermittent spikes during supply disruptions).
4. Include substitution from glass to plastic and supply continuity impacts.

Projected trajectory (directional)

• Adoption: gradual shift toward plastic as procurement policies prioritize safety and handling.
• Pricing: pressure remains structural for generics; price increases tend to be episodic and tied to supply tightness.
• Revenue: grows primarily with unit volume and modest share gains; not with premium pricing.

---

What regulatory and quality factors shape adoption of plastic-container products?

Plastic-container magnesium sulfate products are evaluated on:

• Particulate matter and visual inspection criteria aligned with pharmacopeial standards.
• Container closure integrity and stability under shipping and storage.
• Leachables/extractables testing and controls.
• Compatibility with standard infusion admixtures and infusion set materials.

These requirements often decide whether a product wins hospital formularies and national tenders, which in turn drives market share.

---

Where are the commercial fault lines: supply, compatibility, and formulary inclusion?

Supply reliability Magnesium sulfate injection is a commodity in many markets. When supply tightens, plastic-container formats with robust manufacturing capacity can gain outsized share.

Formulary inclusion Hospitals restrict injectable selections to products with:

• Clean particulate profile
• Documented compatibility with local protocols
• Predictable availability

Compatibility documentation Plastic-container products that reduce uncertainty about Y-site compatibility and admixture handling can win procurement outcomes even when headline costs are similar.

---

Bottom-up commercial projection framework (used for plastic-container carve-outs)

Because “magnesium sulfate in plastic container” is a packaging-specific classification, the carve-out should be built from:

• Concentration and pack size mix (e.g., typical hospital dosing packs)
• Hospital utilization intensity by obstetric and critical-care pathways
• Plastic share by region and facility type
• Procurement lead times and tender cycles

What changes the projection

• New manufacturing capacity for plastic bags
• Regulatory actions tied to particulate or stability data
• Changes in infusion protocol preferences that require more compatible admixture workflows

---

Key Takeaways

• Magnesium sulfate efficacy is already established; clinical activity specific to “plastic container” is typically quality and workflow focused, not molecule-defining registrational trials.
• Demand is anchored by obstetrics and critical care; container format mainly affects procurement, safety, and supply continuity rather than clinical differentiation.
• Market growth for plastic-container magnesium sulfate is expected to be driven by gradual glass-to-plastic substitution and volume expansion, with pricing constrained by generic dynamics.
• Adoption hinges on particulate, stability, container integrity, and compatibility documentation that support hospital formulary inclusion.

---

FAQs

1) Are there phase 3 efficacy trials for magnesium sulfate specifically in plastic containers?
No container-specific registrational phase 3 efficacy trials typically define “magnesium sulfate in plastic container” as a separate therapeutic innovation; evidence is historical for the molecule, while container-specific studies focus on safety and quality attributes.

2) What does “plastic container” change clinically for magnesium sulfate?
It changes handling and quality-control parameters that affect infusion safety (particulates, compatibility, and container integrity), not the underlying pharmacology of magnesium sulfate.

3) What most influences hospital procurement of plastic-container magnesium sulfate?
Unit cost, availability, compatibility documentation, and particulate/stability performance that meet local formulary requirements.

4) How do generic price trends affect market projections?
Pricing typically trends flat-to-declining in real terms for commodity injectables; revenue growth is usually volume- and share-driven rather than premium pricing.

5) What are the biggest risks to supply and pricing for this product category?
Manufacturing capacity constraints, regulatory-quality actions tied to particulate or container integrity, and logistics disruptions that shift demand to the most reliable plastic-container suppliers.

---

References

[1] United States Pharmacopeia (USP). USP <788> Particulate Matter in Injections; USP standards for injectable solutions and containers. USP.
[2] European Pharmacopoeia (Ph. Eur.). Particulate matter and container closure integrity-related monographs and general chapters for injections. European Directorate for the Quality of Medicines.
[3] World Health Organization (WHO). WHO Model List of Essential Medicines (magnesium sulfate for obstetric indications) and associated clinical guidance documents. WHO.