CLINICAL TRIALS PROFILE FOR OSMITROL 15% IN WATER

All Clinical Trials for Osmitrol 15% 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 15% In Water

Condition Name

Condition Name for Osmitrol 15% In Water
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered	1
Recurrent Childhood Malignant Germ Cell Tumor	1
Adult Supratentorial Primitive Neuroectodermal Tumor	1

Condition MeSH

Condition MeSH for Osmitrol 15% In Water
Intervention	Trials
Brain Neoplasms	2
Oligodendroglioma	1
Pinealoma	1
Pneumonia	1

Clinical Trial Locations for Osmitrol 15% In Water

Trials by Country

Trials by Country for Osmitrol 15% In Water
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for Osmitrol 15% In Water
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for Osmitrol 15% In Water

Clinical Trial Phase

Clinical Trial Phase for Osmitrol 15% 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 15% In Water
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for Osmitrol 15% In Water

Sponsor Name

Sponsor Name for Osmitrol 15% 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 15% In Water
Sponsor	Trials
Other	9
NIH	4
Industry	3

OSMITROL 15% in Water: Clinical, Market, and Projection Analysis

Introduction to OSMITROL

OSMITROL, also known as mannitol injection, is a diuretic used intravenously to manage various medical conditions, including the reduction of intraocular and intracranial pressure, promotion of diuresis, and the treatment of acute kidney failure. Here, we will delve into the clinical aspects, market analysis, and future projections for OSMITROL 15% in water.

Clinical Use and Indications

Mechanism of Action

OSMITROL works by exerting an osmotic effect, primarily confined to the extracellular space. This increases the osmolarity of the extracellular fluid, leading to the movement of water from cells into the extracellular space, which helps in reducing intracranial pressure, intracranial edema, and elevated intraocular pressure[5].

Dosage and Administration

For the reduction of intraocular pressure, a dose of 1.5 to 2 grams/kg of a 15% w/v solution (10 to 13 mL/kg) is recommended, administered intravenously over at least 30 minutes. For intracranial pressure reduction, a dose of 0.25 gram/kg is typically used. A test dose may be given to patients with marked oliguria or suspected inadequate renal function to ensure an adequate diuretic response[1][4].

Contraindications and Warnings

OSMITROL is contraindicated in patients with well-established anuria due to severe renal disease, severe pulmonary congestion, or active intracranial bleeding. It should be used cautiously in patients with impaired renal function, as it can exacerbate hemoconcentration and electrolyte imbalances[5].

Clinical Trials Update

As of the latest available data, there are no specific clinical trials focused solely on OSMITROL 15% in water that have been recently updated or concluded. However, ongoing and past clinical trials involving mannitol have generally aimed to assess its efficacy and safety in various clinical settings, such as reducing intracranial pressure and managing acute kidney failure[3].

Market Analysis

Global Market for Mannitol

While there isn't a specific market report dedicated solely to OSMITROL 15% in water, the broader market for mannitol and related medical solutions can provide insights.

• Market Size and Growth: The market for parenteral solutions, including diuretics like mannitol, is part of a larger pharmaceutical market. However, specific data on mannitol's market size is not readily available. Instead, we look at related markets for context.
• Related Markets: The global market for reverse osmosis (RO) system components, which is tangentially related due to the use of osmotic principles, was valued at USD 18.8 billion in 2024 and is projected to reach USD 32 billion by 2029, growing at a CAGR of 11.2%[2].

Market Drivers and Challenges

• Drivers: The increasing need for advanced medical treatments, particularly in neurosurgery and nephrology, drives the demand for drugs like OSMITROL. The growing incidence of conditions requiring diuretic therapy also contributes to market growth.
• Challenges: High costs associated with the administration of mannitol, potential side effects such as electrolyte imbalances and renal impairment, and the need for careful monitoring during treatment are significant challenges.

Market Projections

Future Demand

Given the critical role of OSMITROL in managing acute medical conditions, the demand is expected to remain steady or increase slightly. Here are some key projections:

• Increasing Applications: As medical technology advances and more complex surgeries are performed, the need for effective diuretics like OSMITROL will continue.
• Regulatory Environment: Strict regulations around the use of parenteral solutions will ensure that only high-quality products are available, potentially stabilizing the market.
• Competitive Landscape: The market for diuretics is competitive, but OSMITROL's established reputation and efficacy will help it maintain its market share.

Regional Analysis

The demand for OSMITROL is expected to be high in regions with advanced healthcare systems and a high incidence of conditions requiring its use. This includes North America, Europe, and parts of Asia-Pacific.

Key Takeaways

• Clinical Use: OSMITROL 15% in water is a critical diuretic used in various medical conditions, requiring careful administration and monitoring.
• Market Analysis: While specific market data for OSMITROL is limited, related markets indicate a growing demand for advanced medical solutions.
• Future Projections: The demand for OSMITROL is expected to remain steady due to its essential role in medical treatment, despite challenges and regulatory scrutiny.

FAQs

What is the primary use of OSMITROL 15% in water?

OSMITROL 15% in water is primarily used to reduce intraocular and intracranial pressure, promote diuresis, and treat acute kidney failure.

What are the potential side effects of OSMITROL?

Potential side effects include electrolyte imbalances, hemoconcentration, renal impairment, and in severe cases, congestive heart failure, pulmonary edema, and CNS toxicity[1][5].

How is OSMITROL administered?

OSMITROL is administered intravenously, with the dosage and rate of administration adjusted based on the patient's condition and urinary output[1][4].

What are the contraindications for OSMITROL?

OSMITROL is contraindicated in patients with well-established anuria, severe pulmonary congestion, or active intracranial bleeding[5].

What is the market outlook for OSMITROL?

The market outlook for OSMITROL is stable, driven by its essential role in medical treatment, despite potential challenges and regulatory scrutiny.

Sources

1. OSMITROL (mannitol injection), for intravenous use - FDA Label[1]
2. Major Reverse Osmosis System Components for Water Treatment Market - ResearchAndMarkets.com[2]
3. ClinicalTrials.gov - NCT04000529[3]
4. Osmitrol in Viaflex - RxList[4]
5. OSMITROL Injection (Mannitol Injection, USP) - FDA Label[5]