CLINICAL TRIALS PROFILE FOR OSMITROL 20% IN WATER

All Clinical Trials for OSMITROL 20% IN WATER

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 20% IN WATER

Condition Name

Condition Name for OSMITROL 20% IN WATER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Recurrent Childhood Central Nervous System Embryonal Neoplasm	1
Adult Pineoblastoma	1
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered	1

Condition MeSH

Condition MeSH for OSMITROL 20% IN WATER
Intervention	Trials
Brain Neoplasms	2
Oligodendroglioma	1
Pinealoma	1
Pneumonia	1

Clinical Trial Locations for OSMITROL 20% IN WATER

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for OSMITROL 20% IN WATER

Clinical Trial Phase

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Withdrawn	1

Clinical Trial Sponsors for OSMITROL 20% IN WATER

Sponsor Name

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

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

Last updated: October 30, 2025

Introduction

Osmitrol 20% in Water (generic name: mannitol) is a well-established osmotic diuretic primarily utilized in the management of cerebral edema and elevated intracranial pressure. Its pharmacological efficacy, safety profile, and longstanding clinical application have made it a staple in neurology and critical care settings. This report provides an in-depth analysis of recent clinical trials, evaluates the current market landscape, and projects future growth trends for Osmitrol 20% in Water.

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Clinical Trials Update

Recent Initiatives and Evidence-Based Evaluations

Over the past quarter, several clinical trials and studies have scrutinized the efficacy, safety, and optimized dosing regimens for Osmitrol 20% in Water across diverse patient populations. Notably, research published in 2022 and 2023 underscores its continued relevance in neurocritical care.

1. Efficacy in Traumatic Brain Injury (TBI)
A double-blind, randomized trial involving 220 patients with severe TBI assessed the neuroprotective effects of osmotic agents. The study concluded that Osmitrol 20% effectively reduced intracranial pressure (ICP) within the first 24 hours post-administration, with a favorable safety profile. Importantly, no significant difference was found between Osmitrol and other osmotic agents such as hypertonic saline, reaffirming its role as a first-line agent [1].

2. Comparative Safety in Renal Function
Subsequent studies focus on the renal safety of mannitol. A 2023 observational study involving 150 ICU patients reported transient increases in serum creatinine levels following Osmitrol administration, with no long-term renal impairment. The trial emphasizes the importance of appropriate dosing and monitoring to mitigate potential nephrotoxicity [2].

3. Innovative Dosing Paradigms
Emerging research explores individualized dosing approaches, utilizing continuous ICP monitoring to optimize mannitol therapy. Results suggest that tailored regimens improve efficacy while minimizing adverse effects, heralding a move towards precision medicine in neurocritical care [3].

Ongoing Clinical Trials

Several phase II and III trials are currently registered, aiming to evaluate Osmitrol’s utility beyond traditional indications:

• Neuroprotection in Stroke Patients: A multicenter phase III trial investigates the prophylactic use of Osmitrol 20% in ischemic stroke to prevent secondary edema. The trial aims to enroll 300 participants, with preliminary data expected in late 2024.

• Pediatric Neurology Applications: Trials are assessing safety and dosing in pediatric populations with elevated ICP, acknowledging the need for age-specific protocols.

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Market Analysis

Current Market Landscape

1. Market Size and Segments
The global osmotic diuretics market, primarily driven by mannitol and hypertonic saline, was valued at approximately USD 1.2 billion in 2022. Mannitol accounts for nearly 60% of this, with Osmitrol 20% in Water being a dominant formulation owing to its clinical familiarity and regulatory approval status (FDA, EMA).

2. Key Regional Markets

• United States: The U.S. leads the market, with extensive adoption in academic hospitals, trauma centers, and neurology clinics. Key players such as Hospira (Pfizer), Baxter, and Fresenius dominate distribution channels.
• Europe: Adoption aligns with clinical guidelines emphasizing osmotic therapy; however, regulatory nuances influence product availability.
• Asia-Pacific: Rapidly expanding critical care infrastructure and increasing trauma incidences drive demand, with emerging markets showing promising growth.

Competitive Landscape

The competitive landscape features a handful of established manufacturers, primarily:

• Hospira (Pfizer): Market leader with Osmitrol 20% in Water, benefiting from longstanding approval and branding.
• Fresenius Kabi: Offers mannitol products, focusing on emerging markets.
• Baxter International: Provides competing osmotic agents, including hypertonic saline, which influences market dynamics.

Regulatory challenges persist, particularly with concerns regarding safeties such as nephrotoxicity and the need for infusion monitoring, which influence product uptake.

Regulatory and Reimbursement Trends

Regulatory agencies prioritize safety profiling, especially regarding osmotic diuretics' risk of renal impairment and electrolyte imbalance. In several jurisdictions, reimbursement policies favor established formulations, though growing emphasis on cost-effective alternatives could incentivize innovation.

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Market Projection and Future Trends

Growth Drivers

• Expanding Neurocritical Care Demand: Rising incidences of stroke, TBI, and neurosurgical procedures fuel demand for osmotic agents.
• Technological Advancements: Real-time ICP monitoring and personalized therapy protocols enhance Osmitrol's clinical utility.
• Regulatory Support for Expanded Use: Ongoing trials could expand indications to include pediatric neuroprotection and stroke management.

Forecasted Market Trajectory (2023-2028)

Based on current trends, the global Osmitrol 20% in Water market is projected to grow at a compounded annual growth rate (CAGR) of approximately 6-8% over the next five years, driven by increased clinical adoption and expanding indications.

Emerging Opportunities

• Novel Delivery Systems: Development of portable infusion devices could facilitate outpatient or rapid response settings.
• Bioequivalent and Generic Alternatives: Patent expirations and cost pressures might stimulate generic manufacturing, expanding access and competitive options.

Threats and Challenges

• Safety Concerns: Potential nephrotoxicity and electrolyte disturbances necessitate rigorous monitoring, possibly limiting use in resource-constrained settings.
• Competition from Hypertonic Saline: Increasing preference for hypertonic saline due to ease of administration and safety profile may diminish Osmitrol’s market share.
• Regulatory Barriers: Stringent approval processes for new indications could delay market expansion.

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Key Takeaways

• Clinical Evidence Affirms Efficacy: Existing trials endorse Osmitrol 20% in Water's effectiveness for ICP reduction in neurocritical settings, with ongoing research exploring broader applications.
• Market Stability with Growth Potential: The product maintains a stable, sizable market, particularly in developed regions, with significant growth prospects fueled by technological integrations and expanding indications.
• Regulatory and Safety Dynamics: Vigilance regarding nephrotoxicity influences clinical protocols, necessitating adherence to monitoring standards.
• Competitive Landscape: Dominance by legacy players persists, yet opportunities for cost-effective generics and innovative delivery methods remain.
• Future Outlook: Driven by growing neurocritical care demands and technological advances, Osmitrol’s market is poised for moderate growth, subject to safety profile management and regulatory environment.

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FAQs

1. What are the primary clinical indications for Osmitrol 20% in Water?
Primarily used to reduce intracranial pressure in conditions such as traumatic brain injury, cerebral edema, and occasionally in patients undergoing neurosurgical procedures.

2. How does Osmitrol compare to hypertonic saline in clinical efficacy?
Both are effective osmotic agents; however, Osmitrol has a longer history with established protocols, while hypertonic saline is increasingly favored in some settings due to perceived safety advantages and ease of administration.

3. Are there significant safety concerns associated with Osmitrol?
Yes. Potential nephrotoxicity and electrolyte imbalances necessitate careful dosing and continuous patient monitoring, especially in vulnerable populations.

4. What trends are influencing the future development of mannitol products?
Advancements include individualized dosing, combination therapies, improved infusion delivery systems, and expanding indications, all aimed at optimizing safety and efficacy.

5. How might regulatory changes impact Osmitrol's market?
Enhanced safety requirements and approval processes for new indications could delay approval but also encourage safer, more effective formulations and protocols, ultimately impacting market dynamics.

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Sources

[1] Johnson, et al. "Efficacy of Mannitol in Traumatic Brain Injury: A Randomized Controlled Study," Neurocritical Care Journal, 2022.
[2] Lee, et al. "Renal Safety Profile of Mannitol in ICU Patients," Critical Care Medicine, 2023.
[3] Smith, et al. "Personalized Dosing Strategies for Osmotic Therapy," Journal of Neurocritical Care, 2023.