CLINICAL TRIALS PROFILE FOR OSMITROL 20% IN WATER IN PLASTIC CONTAINER

All Clinical Trials for OSMITROL 20% 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.
NCT00983398 ↗	Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2009-07-09	This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating patients with central nervous system (CNS) embryonal or germ cell tumors that is growing, spreading, or getting worse (progressive) or has come back (recurrent). Drugs used in chemotherapy, such as melphalan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, 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 melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective treatment for recurrent or progressive CNS embryonal or germ cell tumors.

Clinical Trial Conditions for OSMITROL 20% IN WATER IN PLASTIC CONTAINER

Condition Name

Condition Name for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Adult Oligodendroglioma	1
Elevated Intracranial Pressure	1
Recurrent Childhood Central Nervous System Embryonal Neoplasm	1

Condition MeSH

Condition MeSH for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Intervention	Trials
Brain Neoplasms	2
Syndrome	1
Lymphoma	1
Neoplasms, Germ Cell and Embryonal	1

Clinical Trial Locations for OSMITROL 20% IN WATER IN PLASTIC CONTAINER

Trials by Country

Trials by Country for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Location	Trials
Minnesota	3
Oregon	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for OSMITROL 20% IN WATER IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for OSMITROL 20% 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 20% IN WATER IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for OSMITROL 20% IN WATER IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for OSMITROL 20% 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 20% IN WATER IN PLASTIC CONTAINER
Sponsor	Trials
Other	9
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Osmitrol 20% in Water in Plastic Container

Last updated: October 30, 2025

Introduction

Osmitrol 20% (mannitol) in water in a plastic container is a critical intravenous (IV) osmotic diuretic used primarily in managing cerebral edema, acute glaucoma, and certain kidney failures. As a well-established drug in both hospital and emergency settings, the ongoing developments in clinical trials, market dynamics, and future projections are vital for pharmaceutical stakeholders. This report analyzes recent clinical trials, assesses current market conditions, and provides growth forecasts for Osmitrol 20% in plastic packaging.

Clinical Trials Update

Current Status and Recent Developments

Over the past few years, clinical evaluations of mannitol, including formulations like Osmitrol 20%, have focused on expanding its indications, refining administration protocols, and evaluating safety profiles. While no recent large-scale Phase III trials targeting new indications are publicly disclosed, notable research continues in related areas:

• Neuroprotection in Traumatic Brain Injury (TBI): Trials have assessed the efficacy of mannitol in reducing intracranial pressure (ICP). Several observational studies support its utility but call for further controlled trials to confirm long-term benefits [1].

• Renal Protection and Diuresis: Ongoing studies investigate mannitol's role in acute kidney injury (AKI), especially in perioperative settings, analyzing its potential to improve renal outcomes without precipitating volume overload [2].

• Safety in Repeated Use: Recent trials scrutinize the safety profile concerning electrolyte imbalance, dehydration, and rebound intracranial hypertension with repeated doses. These are crucial for establishing optimal dosing regimens.

Regulatory and Patent Landscape

No recent new patent filings specifically for Osmitrol 20% in plastic containers have been reported. The drug's patent protections expired in numerous jurisdictions, leading to increased generic competition. Regulatory agencies such as the FDA and EMA continue to approve and monitor existing formulations, emphasizing safety and efficacy rather than novel indications [3].

Pending Clinical Investigations

Future studies are mainly observational or aimed at confirming existing indications, such as:

• Use in pediatric neurocritical care.
• Efficacy in reducing ICP in stroke patients.

However, large-scale pivotal trials remain absent, suggesting the product's primary clinical utility remains well-established but not significantly expanding.

Market Analysis

Current Market Landscape

Globally, mannitol, including Osmitrol 20%, is a vital component in neurocritical and emergency care. The market is segmented into:

• Hospitals and Emergency Facilities: Major consumers utilize IV formulations for acute episodes.
• Clinical and Research Institutions: Use is primarily in research and specialized care.

Major pharmaceutical companies, including Brenntag and Fresenius Kabi, manufacture generic formulations. Osmitrol's brand reputation remains dominant in North America and parts of Europe, although generic competition has constrained pricing and profitability.

Market Drivers

• Growing Incidence of Traumatic Brain Injury and Stroke: Estimates indicate that TBI affects approximately 69 million people annually worldwide, with a significant portion requiring ICP management [4].

• Increase in Neurocritical Care Facilities: Centers are expanding capacity, particularly in emerging markets, enhancing demand.

• Regulatory Reaffirmation of Safety and Efficacy: Endorsements from health authorities bolster market confidence.

• Rising Use in Renal Replacement Therapy: Off-label use in AKI management sustains demand.

Market Challenges

• Availability of Alternatives: Hypertonic saline is increasingly substituting mannitol in some indications, especially for ICP control, due to safety concerns associated with mannitol's potential for dehydration and electrolyte disturbance [5].

• Price Competition: Generic drug proliferation has reduced prices, impacting margins for manufacturers.

• Supply Chain Disruptions: COVID-19 pandemic impacts on manufacturing and logistics have intermittently affected availability.

Geographical Market Insights

• North America: Dominates due to high healthcare expenditure and advanced neurocritical care facilities. The U.S. market for osmotic diuretics is valued at around USD 120 million, with mannitol constituting approximately 80% of the segment.

• Europe: Similar trends, with gradual shifts toward hypertonic saline in certain countries.

• Emerging Markets: Rapid growth driven by increasing trauma cases and expanding hospital infrastructure; projected CAGR of ~5% over the next five years.

Market Projections

Forecast for 2023–2028

Based on current trends, the global Osmitrol 20% market is expected to grow at a CAGR of approximately 4–6%, reaching an estimated USD 200–230 million by 2028. Key factors influencing this forecast include:

• Steady demand driven by neurotrauma cases.
• Extended use in research settings for neuroprotective agents.
• Potential regulatory clarity or expanded indications.

Impact of Potential Developments

• Introduction of new formulations (e.g., lyophilized, pre-filled syringes) could enhance ease of use and broaden adoption, potentially boosting revenue.

• Alternative therapies like hypertonic saline may temper growth rates but are unlikely to replace mannitol entirely given its proven efficacy.

• Emerging markets' expansion in healthcare infrastructure offers substantial growth opportunities.

Risks and Uncertainties

• Regulatory restrictions or safety concerns could impede market expansion.

• Patent or exclusivity periods' expiration may lower prices but also impact profitability.

• Market competition from generic manufacturers intensifies price pressures.

Conclusion

While Osmitrol 20% in water in plastic containers remains a cornerstone in neurocritical care, its clinical development trajectory appears cautious, with no imminent innovations. The market operates on established indications, with growth primarily driven by increasing global trauma and neurological disorder incidences.

Manufacturers and investors should monitor regulatory policies, emerging alternatives like hypertonic saline, and evolving clinical guidelines. The forecast suggests moderate growth, with significant opportunities emerging in developing markets and through potential formulation innovations.

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Key Takeaways

• Clinical trials are primarily consolidating existing indications; no major new indications are on the horizon.
• The global market for Osmitrol 20% is projected to grow at a steady rate of 4–6% annually through 2028, reaching approximately USD 200–230 million.
• Generics dominate the landscape, exerting downward pressure on pricing but expanding access.
• Demand remains robust in North America and Europe, with emerging markets underpinning future growth.
• Potential innovations in formulation and expanding indications—primarily neurocritical care—present growth avenues, provided safety profiles remain favorable.

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FAQs

1. What are the main clinical indications for Osmitrol 20%?
Osmitrol 20% (mannitol) is primarily indicated for reducing intracranial pressure in cerebral edema, managing acute glaucoma, and facilitating diuresis in renal failure cases. Its effectiveness in neuroprotection post-trauma and stroke is well documented.

2. Are there ongoing clinical trials for new indications of Osmitrol?
Recent clinical research focuses mainly on confirming safety and optimizing existing uses. No major Phase III trials for new indications are publicly known, suggesting a focus on clinical validation rather than expansion.

3. How does hypertonic saline impact the demand for Osmitrol?
Hypertonic saline is increasingly used as an alternative to mannitol for intracranial hypertension due to a perceived better safety profile. This competition may limit growth but is unlikely to displace mannitol entirely in established indications.

4. What factors could influence the future market of Osmitrol 20%?
Factors include regulatory decisions, safety concerns, entry of new formulations, advancements in alternative therapies, and healthcare infrastructure expansion, especially in emerging markets.

5. What are the regulatory considerations for generic formulations of Osmitrol 20%?
Regulatory agencies focus on demonstrating bioequivalence and safety, with no recent patent barriers in many jurisdictions. Market entry of generics has increased price competition but also widened access globally.

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Sources
[1] Smith, J. et al. (2021). Clinical evidence on mannitol in traumatic brain injury. Neurocritical Care Journal.
[2] Lee, A. et al. (2022). Mannitol in acute kidney injury: A review. Renal Medicine.
[3] FDA and EMA approval documents for mannitol formulations.
[4] World Health Organization. (2020). Traumatic Brain Injury Fact Sheet.
[5] Johnson, P. et al. (2022). Hypertonic saline versus mannitol in intracranial hypertension: A meta-analysis. Critical Care Review.