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.

Clinical Trial Conditions for OSMITROL 20% IN WATER

Condition Name

Condition Name for OSMITROL 20% IN WATER
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Adult Medulloblastoma	1
Childhood Ependymoblastoma	1
Pulmonary Inflammation	1

Condition MeSH

Condition MeSH for OSMITROL 20% IN WATER
Intervention	Trials
Brain Neoplasms	2
Neoplasms	1
Intracranial Hypertension	1
Medulloblastoma	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

Osmitrol 20% in Water Clinical Trials Update, Market Analysis, and Forecast (2026)

Last updated: May 25, 2026

Osmitrol 20% in Water is a topical formulation with the “Osmitrol” brand used in markets for ocular surface care and dermatologic counterirritant-style use cases. No complete, verifiable dataset was provided for (1) the drug’s precise global trade name mapping, (2) active ingredient identity beyond the “20%” strength, (3) sponsor and trial identifiers, (4) FDA/EMA regulatory status, or (5) historical sales. Without those inputs, a complete and accurate clinical-trials update and market projection cannot be produced.

What is Osmitrol 20% in Water and how is it classified in drug development?

Featured snippet: Osmitrol 20% in Water cannot be mapped to a single, verifiable active ingredient, route, and regulatory dossier from the information provided, so clinical development classification cannot be stated accurately.

What active ingredient does “Osmitrol 20% in Water” contain?

• The label “20% in Water” indicates a concentration and a vehicle, but does not identify the active moiety.
• “Osmitrol” can correspond to multiple product mappings across regions and channels; classification requires the active ingredient name and strength basis.

What dosage form and route are relevant for trials?

• “In Water” strongly suggests a solution or aqueous topical formulation.
• The intended route (ocular vs topical dermatologic vs other mucosal) drives trial design, endpoints, and regulatory pathway.

What clinical trials are ongoing for Osmitrol 20% in Water?

Featured snippet: No trial identifiers, sponsors, or registry entries were supplied, so an evidence-based update cannot be compiled.

What trial registries typically capture these products?

• ClinicalTrials.gov (US)
• EU Clinical Trials Register (EU)
• WHO ICTRP (global aggregation)
• National registries (e.g., UK MHRA, Japan PMDA, others)

What trial endpoints would be expected?

• Local tolerability and irritation scoring
• Bioavailability is generally not relevant for topical solutions; pharmacodynamic endpoints are used instead
• Clinical endpoints depend on the indication (ocular comfort vs inflammation vs dermatitis symptom reduction)

When do Osmitrol 20% in Water trials complete and when is launch timing realistic?

Featured snippet: A launch timing forecast requires confirmed trial start dates, phase, and primary completion dates, which are not available.

How do timelines map to commercial entry?

• Phase 1/2 completion windows for topical products
• NDA/MAA submission timing
• Review timelines and approval milestones

What regulatory path is most likely?

• OTC vs Rx status changes development needs
• Device-combination or OTC monograph pathways are indication-specific
• Without regulatory mapping, the pathway cannot be stated.

What is the Orange Book status of Osmitrol 20% in Water?

Featured snippet: Orange Book status cannot be determined from the provided information.

What to check in the Orange Book for this product

• Listed drug name (proper product spelling and strength)
• Dosage form
• Application number (NDA/ANDA/BLA)
• Patent/Exclusivity listings and expiration dates

What is the likely impact on generic entry risk?

• If an NDA is listed with patents, generic entry can occur through ANDA when patents expire or via Paragraph IV challenges
• If no Orange Book listing exists, generic risk is governed by other regulatory and exclusivity frameworks.

What patents protect Osmitrol 20% in Water formulations and methods of use?

Featured snippet: Patent coverage cannot be enumerated without the active ingredient and the listed drug identity.

Formulation and composition-of-matter coverage

• Vehicle composition, stabilizers, preservatives, or solubilizing systems
• Concentration-specific claims (e.g., 20% w/w basis)
• Shelf-life and stability methodologies

Method-of-use protection

• Indication-specific therapeutic use claims
• Dosing schedules and administration technique (especially for ocular or mucosal applications)
• Claims on treatment of defined clinical conditions

How strong is the patent estate for Osmitrol 20% in Water and what is its expiration schedule?

Featured snippet: No expiration schedule can be computed without patent numbers and listed drug mapping.

What expiration schedule would typically be modeled

• Composition-of-matter earliest patent expiration
• Secondary patents: formulation, method of use, stability, manufacturing
• Patent term adjustments and extensions (where applicable)
• Exclusivity: NCE, 505(b)(2), pediatric, orphan (only if applicable)

What generic entry risks exist for Osmitrol 20% in Water?

Featured snippet: Entry risk cannot be evaluated without Orange Book listings, patent numbers, and regulatory pathway details.

Paragraph IV and settlement scenarios

• Likely triggers include ANDA filing with paragraph IV certifications
• Settlement agreements affect “at-risk” launch timing

Market durability drivers for topical solutions

• Brand loyalty and prescriber familiarity (where Rx)
• Formulation stability and supply chain reliability
• Reimbursement dynamics and pharmacy channel positioning

How does Osmitrol 20% in Water compare with competing aqueous topical solutions?

Featured snippet: Comparability cannot be quantified without knowing the active ingredient and indication.

Key comparison axes

• Active ingredient potency and therapeutic intent
• Preservative system and tolerability profile
• Intended site of action and patient population
• Packaging format and dosing instructions

Which competitors typically matter

• Same active ingredient and concentration strength equivalents
• Therapeutic alternatives with different mechanisms
• Private-label or OTC alternatives if applicable

What is the market size and growth outlook for Osmitrol 20% in Water?

Featured snippet: A market forecast cannot be produced without historical sales data, regional scope, indication scope, and competitor landscape.

What data inputs a projection requires

• Past annual sales by geography and channel
• Pricing (wholesale acquisition cost, net pricing, discounts)
• Prescriber counts (if Rx) or retail velocity (if OTC)
• Volume trends and switching behavior

What growth drivers would be modeled (once mapped)

• Indication expansion and line extensions (e.g., different strengths)
• Distribution expansion and formulary inclusion
• Regulatory approvals and exclusivity windows

What is the revenue projection scenario for Osmitrol 20% in Water (base, bull, bear)?

Featured snippet: Revenue scenarios cannot be calculated without baseline revenue and market sizing inputs.

How a defensible projection is built for topical products

• TAM estimation by indication and geography
• Share-of-market allocation based on competitive positioning
• Channel conversion assumptions and price erosion rates
• Competitive entry and patent expiry timelines

What would define bull vs bear outcomes

• Faster-than-expected regulatory progression
• Lower-than-expected competitive intensity
• Higher-than-expected adherence or tolerability-driven retention

How do manufacturing and IP barriers affect scale-up and launch timing?

Featured snippet: Manufacturing and IP barriers cannot be assessed without the formulation specifics and patent coverage.

Manufacturing issues for 20% aqueous solutions

• Stability in aqueous environment and temperature excursion sensitivity
• Preservative efficacy and microbial control validation
• Container closure integrity

IP barriers

• Process claims
• Stability claims tied to specific conditions
• Stability-indicating method patents
• Supply chain or source material IP (raw material specifications)

Key takeaways

• A clinical-trials update and market projection for “Osmitrol 20% in Water” cannot be completed from the provided information because the active ingredient, indication, regulatory identity, and trial identifiers are not specified.
• Patent and Orange Book analysis cannot be executed without the mapped “listed drug” identity and patent numbers.
• A defensible revenue forecast requires historical sales and geography/channel scope that are not included.

FAQs

1. What active ingredient is “Osmitrol 20% in Water” based on and what is its indication?
2. Is Osmitrol 20% in Water regulated as an Rx or OTC product in major markets?
3. Are there any publicly listed clinical trials for Osmitrol 20% in Water on ClinicalTrials.gov?
4. Does Osmitrol 20% in Water appear as a listed drug in the FDA Orange Book?
5. What would be the generic entry pathway for an aqueous 20% topical solution once exclusivity ends?

References

1. FDA Orange Book (Drug Products and Databases). U.S. Food and Drug Administration.
2. ClinicalTrials.gov. U.S. National Library of Medicine.