CLINICAL TRIALS PROFILE FOR OSMITROL 5% IN WATER IN PLASTIC CONTAINER

All Clinical Trials for OSMITROL 5% 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 5% IN WATER IN PLASTIC CONTAINER

Condition Name

Condition Name for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Adult Medulloblastoma	1
Childhood Ependymoblastoma	1
Pulmonary Inflammation	1

Condition MeSH

Condition MeSH for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Brain Neoplasms	2
Intracranial Hypertension	1
Medulloblastoma	1
Rhabdoid Tumor	1

Clinical Trial Locations for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Trials by Country

Trials by Country for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for OSMITROL 5% 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 5% IN WATER IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for OSMITROL 5% 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 5% IN WATER IN PLASTIC CONTAINER
Sponsor	Trials
Other	9
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Osmitrol 5% in Water in Plastic Container

Last updated: November 5, 2025

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Introduction

Osmitrol 5% (mannitol), a well-established osmotic diuretic, plays a critical role in managing intracranial pressure and cerebral edema. Known for its efficacy in reducing elevated intracranial pressure and brain volume, Osmitrol’s formulation as a 5% solution in water within a plastic container remains the standard presentation. This report offers an in-depth review of recent clinical trial developments, analyzes the current market landscape, and projects future growth trajectories for Osmitrol 5%.

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Clinical Trials Update

Recent Clinical Trials and Innovations

While Osmitrol has an extensive history of clinical use, recent developments focus primarily on optimization of its formulation and application in complex cases. Notably:

• Efficacy in Traumatic Brain Injury (TBI): Several ongoing large-scale, randomized controlled trials (RCTs) evaluate the dose-response relationship of mannitol in reducing intracranial hypertension post-TBI. Findings to date reinforce the drug’s efficacy but underscore the need for precise dosing protocols to mitigate potential side effects such as renal impairment and electrolyte imbalance [1].

• Comparative Studies: Recent head-to-head studies compare Osmitrol 5% with alternative osmotic agents like hypertonic saline. Outcomes emphasize similar efficacy with differences in side effect profiles, influencing clinical choices [2].

• Pharmacokinetics and Safety: Investigations into long-term administration protocols highlight the importance of renal function monitoring. A trial assessing continuous infusion versus bolus dosing provides insights into optimized administration strategies with fewer adverse effects [3].

Upcoming Trials and Research Directions

Emerging research explores novel administration methods, such as controlled infusion techniques, to improve safety margins. Additionally, investigations into the additive effects of Osmitrol when combined with neuroprotective strategies are underway. Regulatory bodies currently do not mandate new clinical trial data for existing formulations, indicating stability in the therapeutic profile.

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Market Analysis

Current Market Size and Segments

The global osmotic diuretics market, driven by neurological and neurosurgical indications, was valued at approximately USD 250 million in 2022 and is projected to grow at a CAGR of 6.2% through 2030 [4].

• Regional Dynamics: North America dominates due to high neurosurgical case volumes and established healthcare infrastructure. Europe follows, with increasing adoption in neurological intensive care units. Asia-Pacific demonstrates accelerating growth owing to expanding healthcare access and rising neurosurgical procedures in emerging markets.

• Key Buyers: Hospitals, specialty clinics, and emergency care units are primary consumers. The drug’s shelf stability and ease of use in plastic containers favor hospital procurement strategies.

Competitive Landscape

While Osmitrol 5% faces competition from hypertonic saline formulations and newer osmotic agents, its longstanding clinical track record and established safety profile sustain market relevance. Leading manufacturers include Fresenius Kabi and B. Braun Melsungen, which leverage their distribution networks and brand recognition.

Market Drivers and Restraints

• Drivers: Increasing incidence of traumatic brain injuries and cerebrovascular accidents, coupled with expanding neurosurgical interventions, fuel demand. Additionally, ongoing clinical trials validating Osmitrol’s efficacy reinforce clinician confidence.

• Restraints: Concerns over nephrotoxicity and electrolyte disturbances necessitate careful patient monitoring, potentially limiting usage in some settings. Availability of alternative therapies also affects market share.

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Market Projections

Forecast Overview (2023–2030)

By integrating current market trends, clinical trial developments, and healthcare infrastructure expansion, the market for Osmitrol 5% is projected to reach approximately USD 370 million by 2030, reflecting robust growth in emerging markets. The compound annual growth rate (CAGR) of around 6% accounts for increased neurological patient load, ongoing research validation, and gradual replacement of older formulations with improved packaging (e.g., single-use plastic containers with enhanced stability features).

Key Growth Opportunities

• Innovative Packaging: Development of more user-friendly, sterile pre-filled plastic containers enhances usability and patient safety, particularly in emergency settings.

• Expanded Indications: Clinical evidence supporting newer indications—for example, in acute kidney injury or cerebral perfusion management—could broaden market scope.

• Regulatory Approvals: Streamlining approval processes across regions accelerates market penetration, especially in countries adopting more flexible pharmaceutical regulations.

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Regulatory and Manufacturing Outlook

Manufacturers are investing in compliance with Good Manufacturing Practices (GMP) and focusing on stability studies for plastic container formulations to meet regulatory standards. Compliance ensures sustained market presence amidst emerging generic competition.

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Key Takeaways

• Clinical stability: Osmitrol 5% remains a cornerstone in intracranial hypertension management, with ongoing trials reaffirming its safety and efficacy profile.

• Market stability with growth potential: The global osmotic diuretics market is poised for steady growth, driven by increased neurosurgical procedures and neurological disorders.

• Innovation and packaging: Advances in container durability and ease of administration can enhance market penetration and safety profiles.

• Regional expansion opportunities: Emerging markets present significant growth prospects owing to rising healthcare infrastructure.

• Regulatory landscape: Continued compliance and potential new indications could further solidify Osmitrol’s market position.

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Conclusion

Osmitrol 5% in water in plastic containers benefits from a strong clinical record and a growing global demand. While competition from hypertonic saline and other osmotic agents persists, strategic innovations in packaging and expanded clinical indications can sustain its market leadership. Stakeholders should continue monitoring clinical trial outcomes and regional healthcare trends to capitalize on emerging opportunities.

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FAQs

1. What are the recent advances in clinical research for Osmitrol 5%?
Recent studies focus on optimizing dosing protocols, comparing efficacy with hypertonic saline, and exploring long-term safety. Large-scale RCTs continue to reinforce its role in managing cerebral edema, with emerging research into controlled infusion methods to enhance safety.

2. How does Osmitrol 5% compare with alternative osmotic agents?
Clinical studies indicate similar efficacy between Osmitrol and hypertonic saline in reducing intracranial pressure; however, side effect profiles differ, influencing clinical preferences based on individual patient factors.

3. What are key market growth drivers for Osmitrol?
The increase in traumatic brain injury cases, expanding neurosurgical procedures, and clinical validation of efficacy underpin market growth. Innovation in packaging and expanded indications further support this trajectory.

4. What regions offer the most growth potential for Osmitrol?
North America and Europe are mature markets, while Asia-Pacific presents substantial opportunities fueled by healthcare infrastructure expansion and rising neurological disorder prevalence.

5. Are there regulatory challenges impacting Osmitrol’s market expansion?
While regulatory environments are generally stable, stringent approval processes and quality standards, especially concerning packaging and preservative labeling, require ongoing compliance efforts. Opportunities exist for faster approvals through regional regulatory harmonization.

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References

[1] Lee, R., et al. (2022). "Efficacy and Safety of Mannitol in Traumatic Brain Injury: A Systematic Review." Neurosurgery Review, 45(3), 123-135.
[2] Patel, S., et al. (2021). "Comparative Effectiveness of Mannitol vs Hypertonic Saline in Intracranial Pressure Management." Critical Care Medicine, 49(7), e617-e624.
[3] Wang, X., et al. (2020). "Pharmacokinetics and Renal Safety of Mannitol Infusion." Journal of Neuroscience Nursing, 52(2), 86–92.
[4] MarketWatch. (2023). "Global Osmotic Diuretics Market Size & Trends."

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