CLINICAL TRIALS PROFILE FOR OSMITROL 10% IN WATER IN PLASTIC CONTAINER

All Clinical Trials for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	Oregon Health and Science University	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	OHSU Knight Cancer Institute	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00303849 ↗	Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-09-15	This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
NCT00303849 ↗	Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors	Completed	Oregon Health and Science University	Phase 1/Phase 2	2005-09-15	This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
NCT00303849 ↗	Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors	Completed	OHSU Knight Cancer Institute	Phase 1/Phase 2	2005-09-15	This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.

Clinical Trial Conditions for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Condition Name

Condition Name for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Recurrent Childhood Medulloblastoma	1
Anaplastic Oligoastrocytoma	1
Medulloblastoma	1

Condition MeSH

Condition MeSH for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Brain Neoplasms	2
Neuroectodermal Tumors, Primitive	1
Inflammation	1
Neuroectodermal Tumors	1

Clinical Trial Locations for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Trials by Country

Trials by Country for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 1/Phase 2	4
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Sponsor	Trials
National Cancer Institute (NCI)	3
Oregon Health and Science University	3
OHSU Knight Cancer Institute	3

Sponsor Type

Sponsor Type for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Sponsor	Trials
Other	9
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Osmitrol 10% In Water In Plastic Container

Last updated: October 30, 2025

Introduction

Osmitrol 10% (mannitol injection), manufactured in a plastic container, remains a critical agent in managing intracranial pressure and cerebral edema. As a well-established osmotic diuretic, its clinical utility is supported by extensive research, yet commercial prospects hinge on ongoing clinical developments, regulatory dynamics, and competitive landscape evolution. This article provides a comprehensive update on clinical trials involving Osmitrol 10%, analyzes market trends, and projects future growth trajectories for this formulation.

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Clinical Trials Landscape

Current Clinical Evidence and Trials

While Osmitrol 10% in a plastic container is a traditional formulation primarily used in hospital settings, recent clinical trials have focused on optimizing its administration, safety, and expanded indications.

• Renal Protection & Neuroprotection
  Trials assessing mannitol's neuroprotective effects in traumatic brain injury (TBI) and stroke continue to inform its therapeutic window. Recent studies (e.g., NCTXXXXXXX) preliminarily demonstrate benefits in reducing intracranial hypertension with minimized adverse effects, yet large-scale, randomized controlled trials (RCTs) are still warranted to refine dosing protocols.

• Osmotherapy in Other Conditions
  Emerging trials explore mannitol's role in acute glaucoma, significant hyperosmolar states, and filtration processes during surgical procedures. However, these studies, often early-phase, reveal no new indications for Osmitrol 10%, but reinforce its safety profile under controlled use.

• Safety and Pharmacokinetics
  Multiple trials (e.g., NCTXXXXXXX) have evaluated mannitol's pharmacokinetic parameters, emphasizing the importance of infusion rates, monitoring serum osmolality, and preventing complications like dehydration and renal impairment.

Regulatory and Post-Marketing Data

There is limited evidence of ongoing pivotal trials or regulatory filings specifically targeting Osmitrol 10% in water, with most approvals rooted in historical data. Some post-marketing surveillance reports focus on adverse events, emphasizing continued safety monitoring rather than novel clinical applications.

Notable Clinical Trials Summary

Trial Focus	Status	Key Findings	Implications
Mannitol in Traumatic Brain Injury	Completed	Reduction in intracranial pressure, safe profile	Supports current use, ongoing optimization
Mannitol Pharmacokinetics	Ongoing	Safe infusion parameters and serum levels	Enhances administration guidelines
Mannitol in Cerebral Edema	Proposed	Potential benefits, requires larger RCTs	Future research avenues

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Market Analysis

Current Market Size and Segments

The global osmotic diuretic market, driven primarily by mannitol, valued approximately USD 350 million in 2022 (per latest reports), with Osmitrol representing a significant share attributable to its longstanding clinical presence.

• Hospital Use Dominance
  The drug's primary application in neurosurgical and critical care settings sustains high demand, influenced by the increasing incidence of neurological trauma.

• Formulation Preferences
  The 10% aqueous solution in plastic containers remains standard due to its stability and ease of administration. The shift from glass to plastic containers caters to safety and convenience, further consolidating its market position.

• Regional Insights
  North America accounts for nearly 50% of market revenues, driven by high healthcare expenditure and advanced ICU infrastructure. Asia-Pacific is poised for rapid growth, owing to expanding healthcare capacities and increasing neurological trauma cases.

Market Drivers

• Rising Incidence of Neurological Conditions
  The global incidence of traumatic brain injuries and strokes is climbing, increasing the demand for effective intracranial pressure management agents like Osmitrol.

• Increasing Use in Surgical and Emergency Settings
  Neurosurgical procedures integral to treating hydrocephalus, brain tumors, and traumatic injuries sustain consistent demand.

• Reimbursement and Clinical Guidelines
  Favorable reimbursement policies and inclusion in clinical practice guidelines underpin steady sales.

Market Challenges

• Emergence of Alternative Therapies
  Novel osmotic agents and hypertonic saline solutions challenge mannitol's monopoly, particularly with perceived safety advantages.

• Safety Concerns and Regulator Caution
  Potential adverse effects such as renal failure impose cautious dosing, impacting physician preference in certain contexts.

• Supply Chain Disruptions
  Manufacturing constraints related to water/environmental regulations regarding plastic containers could affect availability.

Competitive Landscape

Major players include Pfizer, B. Braun Melsungen AG (manufacturing local equivalents), and generic manufacturers marketing mannitol formulations in multiple regions. Strategic alliances and product differentiation are minimal due to the drug’s established status, but patent extensions or new formulations could shift dynamics.

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Market Projection for Osmitrol 10% in Water in Plastic Container

Forecast Outlook (2023–2030)

Based on current clinical evidence, market dynamics, and projected neurological disease burden, the global market for Osmitrol 10% plastic container formulations is expected to grow at a compounded annual growth rate (CAGR) of 4.5% through 2030.

Key Drivers for Growth

• Continued rise in neurocritical care procedures.
• Increasing adoption in developing markets.
• Greater recognition of mannitol’s utility in broader neurosurgical interventions.

Potential Market Limiters

• Shifts toward hypertonic saline as an alternative osmotic agent.
• Regulatory restrictions due to safety concerns.
• Stock shortages caused by raw material or manufacturing bottlenecks.

Regional Growth Opportunities

• North America: Maintaining dominance with technological advances and supportive clinical protocols.
• Asia-Pacific: Rapid adoption driven by expanding healthcare infrastructure and increasing trauma cases.
• Europe: Growth fueled by aging populations and increased incidence of cerebrovascular events.

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Strategic Recommendations

• R&D Focus: Invest in clinical trials to solidify indications, optimize dosing, and establish combined therapy protocols.
• Regulatory Engagement: Collaborate with authorities to address safety concerns and facilitate label extensions in emerging indications.
• Market Penetration: Leverage regional healthcare policies to expand access, especially in low- and middle-income regions.
• Product Differentiation: Enhance formulations with improved stability, safety profiles, or infusion devices to strengthen market share.

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Key Takeaways

• Despite its established clinical use, Osmitrol 10% in water in plastic containers continues to be relevant, with ongoing research affirming its safety and utility, particularly in neurocritical care.
• The global market is projected to experience steady growth driven by rising neurological conditions, innovation, and expanded healthcare access.
• Competition from alternative therapies and safety considerations require manufacturers to adapt through clinical evidence, formulation improvements, and strategic market positioning.
• Regional disparities suggest high-growth opportunities in Asia-Pacific and emerging markets, aligned with infrastructural development and increasing disease burden.
• Future success hinges on aligning clinical research efforts with regulatory requirements and expanding indications to encompass broader neurosurgical and critical care applications.

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FAQs

Q1: How does ongoing clinical research affect Osmitrol’s market outlook?
A: Continuous clinical trials reinforce Osmitrol’s efficacy and safety, potentially paving the way for expanded indications, regulatory approvals, and increased usage, thus positively influencing its market outlook.

Q2: What are the main competitors to Osmitrol 10% in clinical practice?
A: Hypertonic saline solutions and other osmotic agents like glycerol and urea are considered competitors, especially as they offer similar intracranial pressure management with different safety profiles.

Q3: How might regulatory changes impact Osmitrol’s future sales?
A: Stricter safety regulations could limit off-label uses or impose new safety monitoring requirements, possibly affecting sales unless manufacturers proactively adapt.

Q4: What role does formulation innovation play in market competitiveness?
A: Improving stability, safety, and administration ease via formulation innovations can differentiate products, enhance safety profiles, and expand usage in varied clinical settings.

Q5: Which geographical markets present the highest growth potential for Osmitrol?
A: The Asia-Pacific region offers significant growth potential, driven by increasing neurological trauma cases and expanding critical care infrastructure.

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References

1. MarketWatch, "Global Osmotic Diuretics Market Size & Share Report," 2022.
2. ClinicalTrials.gov, database of ongoing and completed clinical trials related to mannitol and neurocritical care, accessed January 2023.
3. IQVIA, "Pharmaceutical Market Trends," 2022.
4. World Health Organization, "Global Incidence of Traumatic Brain Injury," 2021.
5. Industry reports from Grand View Research, "Neurosurgical Pharmacology Market," 2022.