CLINICAL TRIALS PROFILE FOR DIMETHYL SULFOXIDE

All Clinical Trials for DIMETHYL SULFOXIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118313 ↗	Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma	Completed	National Cancer Institute (NCI)	Phase 1	2004-11-04	RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
NCT00118313 ↗	Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma	Completed	Craig L Slingluff, Jr	Phase 1	2004-11-04	RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
NCT00317070 ↗	Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)	Terminated	Nova Scotia Health Authority	Phase 2	2006-04-01	The primary objective of this study is to evaluate the efficacy and tolerability of the intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the treatment of painful bladder syndrome including interstitial cystitis.
NCT00388687 ↗	Hypoxia Imaging With 18F FAZA. Prognostic Impact in Cervical Cancer	Unknown status	Medical University of Vienna		2006-07-01	The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative changes and the biological behavior of cervical carcinoma (primary and / or lymph nodes) before, during and after radiochemotherapy with the novel hypoxia PET tracer 18FAZA.

Clinical Trial Conditions for DIMETHYL SULFOXIDE

Condition Name

Condition Name for DIMETHYL SULFOXIDE
Intervention	Trials
Hematopoietic and Lymphoid Cell Neoplasm	5
Refractory Lymphoma	4
Refractory Malignant Solid Neoplasm	4
Advanced Lymphoma	4

Condition MeSH

Condition MeSH for DIMETHYL SULFOXIDE
Intervention	Trials
Neoplasms	7
Melanoma	5
Lymphoma	5
Cystitis, Interstitial	5

Clinical Trial Locations for DIMETHYL SULFOXIDE

Trials by Country

Trials by Country for DIMETHYL SULFOXIDE
Location	Trials
United States	112
Egypt	3
Israel	3
Italy	2
Syrian Arab Republic	1

Trials by US State

Trials by US State for DIMETHYL SULFOXIDE
Location	Trials
Pennsylvania	8
Florida	5
California	4
Colorado	3
Tennessee	3

Clinical Trial Progress for DIMETHYL SULFOXIDE

Clinical Trial Phase

Clinical Trial Phase for DIMETHYL SULFOXIDE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for DIMETHYL SULFOXIDE
Clinical Trial Phase	Trials
Completed	12
Active, not recruiting	7
Unknown status	6

Clinical Trial Sponsors for DIMETHYL SULFOXIDE

Sponsor Name

Sponsor Name for DIMETHYL SULFOXIDE
Sponsor	Trials
National Cancer Institute (NCI)	12
GlaxoSmithKline	2
Mayo Clinic	2

Sponsor Type

Sponsor Type for DIMETHYL SULFOXIDE
Sponsor	Trials
Other	32
NIH	12
Industry	7

DIMETHYL SULFOXIDE Market Analysis and Financial Projection

Last updated: February 4, 2026

Clinical Trials Update, Market Analysis, and Projection for Dimethyl Sulfoxide (DMSO)

What is the current status of clinical research involving DMSO?

DMSO has been investigated primarily for its anti-inflammatory, analgesic, and preservative properties. Current clinical trials are limited compared to the past. As of 2023, no large-scale, phase III trials are active or planned to evaluate DMSO as a primary treatment across widespread indications. Most ongoing research focuses on niche applications, such as:

• Topical treatment for interstitial cystitis
• Preservation of stem cells
• Complementary uses in cryopreservation

The National Institutes of Health (NIH) reports fewer than five active trials involving DMSO, with the most recent completed or active studies dating back two to three years, mainly exploring safety profiles or specific indications like scleroderma [1].

How has the regulatory landscape affected DMSO research?

DMSO remains a substance with limited regulatory approval. The FDA approved DMSO in 1963 for the reduction of pain and swelling caused by interstitial cystitis but has since restricted its broader use. The key issues include:

• Safety concerns regarding systemic toxicity
• Reports of adverse effects, such as skin irritation, garlic-like odor, and potential DNA interactions
• Lack of large-scale confirmatory trials supporting broader indications

The absence of new regulatory approvals restricts industry-funded research, with most studies conducted in academic settings.

What is the market size and growth trend for DMSO-based products?

Despite limited formal drug approvals, DMSO-based formulations, mainly topical products, are commercially available. The market size is estimated at approximately $100 million in 2022, with a compound annual growth rate (CAGR) of around 3% projected through 2030.

Key market segments:

• Over-the-counter (OTC) topical solutions for rheumatologic conditions
• Cryopreservation supplies, primarily in biobank and fertility markets
• Niche pharmaceutical formulations for specific indications

The primary drivers include demand for cryopreservation and the longstanding use of DMSO in research laboratories.

How does the competitive landscape look?

The market's competitive landscape involves primarily small biotech firms, research institutions, and generic pharmaceutical companies. No dominant pharmaceutical player controls DMSO formulations fully. Major players:

• Sigma-Aldrich (a subsidiary of Merck): supplies bulk DMSO for research and cryopreservation
• Bio-Pharm LLC: markets OTC topical DMSO products
• Several biotech firms exploring derivative compounds with reduced toxicity profiles

High barriers relate to safety concerns, limited patent protection, and regulatory restrictions.

What are future market projections based on current trends?

Projected growth depends heavily on:

• New medical applications with demonstrated safety and efficacy
• Advances in formulation technology to mitigate toxicity
• Regulatory approvals for expanded indication use

If DMSO gains approval for specific medical indications, the market could expand substantially. For example, a hypothetical approval for treatment-resistant inflammatory conditions could increase market size to $500 million within five years [2].

However, without breakthroughs in safety profiling or definitive clinical trial data, growth remains modest.

How might emerging research influence development?

Strategies under consideration:

• Developing derivatives or formulations with lower systemic toxicity
• Combining DMSO with targeted therapies
• Focusing on niche applications where safety concerns are minimized

Emerging research efforts are slow due to regulatory hesitancy and competing new modalities.

Summary

DMSO remains a niche compound with limited clinical development. Existing markets are small, centered on cryopreservation and OTC topical use. Future growth hinges on overcoming safety issues and establishing efficacy through robust clinical trials.

Key Takeaways

• Clinical research on DMSO is sparse, with no active phase III trials since 2020.
• Market size is roughly $100 million, with steady but slow growth projections.
• Regulatory restrictions limit research expansion; safety concerns persist.
• Future market growth depends on safety advancements and novel indications.
• Competitive landscape involves small firms and research institutions.

FAQs

1. Can DMSO be approved for new medical uses in the near term?
Approval is unlikely without significant safety data from large-scale trials. Regulatory agencies require proof of efficacy and safety before approving new indications.

2. What are the main safety issues associated with DMSO?
Potential adverse effects include skin irritation, garlic-like odor, systemic toxicity, and DNA interaction risks. These concerns limit broad application.

3. Which markets present the most growth potential for DMSO?
Cryopreservation and niche topical treatments are mature markets. Future growth may come from therapies that effectively address safety issues.

4. Are there any competitors developing DMSO derivatives?
Yes, several biotech firms are researching derivatives that aim to retain DMSO’s beneficial properties while reducing toxicity.

5. How does the regulatory environment impact DMSO’s commercial prospects?
Regulatory restrictions restrict research scope and market expansion, limiting potential commercial growth until safety and efficacy are conclusively demonstrated.

References

[1] NIH ClinicalTrials.gov, 2023.
[2] MarketResearch.com, 2022.