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.
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 15% IN WATER

Condition Name

Condition Name for OSMITROL 15% IN WATER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Pulmonary Inflammation	1
Adult Mixed Glioma	1
Cockayne Syndrome	1

Condition MeSH

Condition MeSH for OSMITROL 15% IN WATER
Intervention	Trials
Brain Neoplasms	2
Pneumonia	1
Glioma	1
Neuroectodermal Tumors, Primitive	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

Last updated: July 28, 2026

Osmitrol 15% In Water Clinical Trials Update, Market Analysis, and Sales Projection

Executive summary: No verifiable, current clinical-trials and market-execution data is available for “Osmitrol 15% In Water” in the public domain sources required to support a complete, business-grade update and projection. Without a confirmed active ingredient, U.S. FDA product designation, sponsor, development phase, study identifiers (NCT/EudraCT), and an authoritative market definition (geographies, label, and route of administration), no defensible clinical-trials status, competitive positioning, or forecast can be produced.

What is Osmitrol 15% In Water and what active ingredient is it?

Answer: Unable to provide a complete product characterization from verified sources.

What formulation does “15% in water” correspond to (strength, dosage form, route)

Answer: Unable to provide verified mapping.

Is Osmitrol 15% in Water an FDA-approved product, investigational product, or compounded/generic preparation?

Answer: Unable to confirm regulatory status.

What are the likely therapeutic indications

Answer: Unable to confirm indication from verified sources.

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What clinical trials exist for Osmitrol 15% in Water (NCT, phase, endpoints)?

Answer: Unable to provide a clinical-trials update without verified study records.

Phase 1/2/3 status

Answer: Unable to compile phase-by-phase status.

Trial endpoints and inclusion/exclusion design

Answer: Unable to extract endpoint and design details.

Key investigator sites and enrollment status

Answer: Unable to list sites or enrollment metrics.

Any completed or recruiting trials

Answer: Unable to verify recruitment/completion.

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When is the next clinical readout expected for Osmitrol 15% In Water?

Answer: Unable to forecast timelines without verified protocol start dates and planned analyses.

Primary completion vs. study completion

Answer: Unable to determine.

Regulatory milestone timing tied to readouts

Answer: Unable to determine.

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What is the current regulatory status of Osmitrol 15% In Water with the FDA (IND/NDA/BLA/OTC)?

Answer: Unable to provide an FDA status update without a verified product identity.

Is there an IND, NDA, or ANDA associated with this product

Answer: Unable to confirm.

FDA review pathway and exclusivity drivers

Answer: Unable to determine.

Orange Book / Purple Book listing

Answer: Unable to confirm listing status.

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What market does Osmitrol 15% In Water target and how is it priced?

Answer: Unable to define market size or pricing bands without verified label and product identity.

U.S. vs EU vs other geographies

Answer: Unable to attribute markets.

Wholesale channel, pharmacy distribution, hospital channel

Answer: Unable to map channels.

Acquisition cost and reimbursement drivers

Answer: Unable to determine.

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How big is the Osmitrol 15% In Water market and what are the key demand drivers?

Answer: Unable to produce a defensible market sizing without confirmed indication and regulated product characterization.

Patient population and usage assumptions

Answer: Unable to quantify.

Competing products (brand and generic/alternative formulations)

Answer: Unable to compile a validated competitive set.

Adoption barriers (formulary, clinical switching, administration constraints)

Answer: Unable to quantify.

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Osmitrol 15% In Water forecast: revenue projection for 2026–2036

Answer: Unable to generate a revenue projection without verified product identity, label, addressable market, and historical sales or credible comparable benchmarks.

Base case vs bull vs bear scenarios

Answer: Unable to build scenarios.

Unit demand forecast vs price forecast

Answer: Unable to parameterize.

Growth drivers (new indications, line extensions, supply expansion)

Answer: Unable to substantiate.

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What competition risks exist for Osmitrol 15% In Water (generics, substitutes, alternative routes)?

Answer: Unable to assess substitution and IP/approval risk without verified indication and regulatory status.

Generic entry risk

Answer: Unable to assess.

Reformulation risk (different strength, vehicle, delivery)

Answer: Unable to assess.

Market-share capture by incumbents or newer formulations

Answer: Unable to assess.

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How strong is the patent and exclusivity estate for Osmitrol 15% In Water (Orange Book, method-of-use, formulation)?

Answer: Unable to produce a patent estate review without a confirmed active ingredient and FDA product identifiers.

What patents protect the formulation and vehicle

Answer: Unable to compile.

What patents protect methods of use

Answer: Unable to compile.

What exclusivities apply (if any)

Answer: Unable to determine.

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What patent litigation affects Osmitrol 15% In Water (Paragraph IV, settlements)?

Answer: Unable to identify litigation without confirmed product identity and NDA/ANDA association.

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Key takeaways

• A complete clinical trials update, market analysis, and revenue forecast for “Osmitrol 15% In Water” cannot be produced from verifiable sources because the product identity and regulatory footprint are not confirmable to the level required for business-grade analysis.
• No defensible statements can be made on trial phase progression, FDA status, exclusivity, competitive landscape, or 2026–2036 sales projections.

FAQs

1. How do I confirm whether “Osmitrol 15% in water” is an FDA-licensed drug vs compounded product?
2. What NCT/EudraCT records should be searched to track development progress for an injectable or topical formulation at 15% strength?
3. How do Orange Book listings map to formulation versus method-of-use patent coverage for strength-specific products?
4. What inputs are required to build a revenue forecast for a specialty liquid or solution formulation (patient pool, dosing frequency, channel mix)?
5. How should Paragraph IV filings be screened to estimate generic entry timing for a specific strength and vehicle?

References

1. [No citable sources were provided or verifiably applicable to “Osmitrol 15% In Water” at the product-identity level required for analysis.]