CLINICAL TRIALS PROFILE FOR ISOPROPYL ALCOHOL

505(b)(2) Clinical Trials for Isopropyl Alcohol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.

All Clinical Trials for Isopropyl Alcohol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00247897 ↗	Comparing Skin Disinfectants Before Labour Epidural Analgesia	Completed	University of British Columbia	N/A	2005-11-01	The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Medical College of Wisconsin	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Michael Debakey Veterans Affairs Medical Center	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Michael E. DeBakey VA Medical Center	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	US Department of Veterans Affairs	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	VA Office of Research and Development	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

Clinical Trial Conditions for Isopropyl Alcohol

Condition Name

Condition Name for Isopropyl Alcohol
Intervention	Trials
Nausea	5
Surgical Site Infection	4
Anesthesia, Local	3
Breast Surgery	3

Condition MeSH

Condition MeSH for Isopropyl Alcohol
Intervention	Trials
Infections	7
Communicable Diseases	6
Surgical Wound Infection	5
Infection	4

Clinical Trial Locations for Isopropyl Alcohol

Trials by Country

Trials by Country for Isopropyl Alcohol
Location	Trials
United States	40
Canada	8
Thailand	1
United Kingdom	1
Italy	1

Trials by US State

Trials by US State for Isopropyl Alcohol
Location	Trials
California	10
Texas	7
Florida	5
Illinois	3
Montana	3

Clinical Trial Progress for Isopropyl Alcohol

Clinical Trial Phase

Clinical Trial Phase for Isopropyl Alcohol
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	19
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Isopropyl Alcohol
Clinical Trial Phase	Trials
Completed	29
Recruiting	10
Not yet recruiting	7

Clinical Trial Sponsors for Isopropyl Alcohol

Sponsor Name

Sponsor Name for Isopropyl Alcohol
Sponsor	Trials
University of California, San Diego	10
University of British Columbia	3
University of Florida	3

Sponsor Type

Sponsor Type for Isopropyl Alcohol
Sponsor	Trials
Other	55
Industry	12
U.S. Fed	6

Clinical Trials Update, Market Analysis, and Projection for Isopropyl Alcohol (IPA)

Last updated: November 7, 2025

Introduction

Isopropyl alcohol (IPA), also known as 2-propanol, is a widely used antiseptic, disinfectant, and solvent. Its role extends beyond industrial applications into healthcare, pharmaceuticals, and consumer products. Despite its longstanding usage, recent developments warrant comprehensive analysis of clinical trial activity, market dynamics, and future projections. This report synthesizes current clinical trial updates, evaluates market trends, and offers strategic insights for stakeholders.

Clinical Trials Overview of Isopropyl Alcohol

Current Clinical Trial Landscape

Historically, IPA's clinical exploration has been limited, primarily focusing on its antiseptic efficacy, skin tolerance, and safety profiles. The COVID-19 pandemic amplified interest in disinfectants like IPA, leading to an uptick in clinical evaluations related to infection control. According to clinical trial repositories such as ClinicalTrials.gov, less than a dozen recent studies have explicitly targeted IPA, many of which examine its effectiveness in disinfecting surfaces and skin.

A notable clinical trial, NCT04586619, assessed IPA's efficacy for hand hygiene amid the COVID-19 pandemic, confirming its rapid antimicrobial activity while highlighting skin irritation concerns. The trial results underscore IPA's continued importance in infection prevention protocols, especially when formulated appropriately.

Research Focus and Limitations

Most ongoing trials evaluate formulation improvements: enhancing skin tolerability, reducing evaporation rates, and increasing residual activity. Few trials directly investigate new therapeutic applications, indicating IPA's established role in disinfection rather than drug development. The predominance of topical and surface disinfection studies suggests clinical research activity is more aligned with regulatory standards for safety and efficacy rather than therapeutic innovation.

Regulatory and Safety Considerations

FDA and EMA regulations underscore IPA's safety, emphasizing skin irritation thresholds and inhalation risks. Recent research emphasizes optimizing formulations to minimize adverse effects, especially with high-frequency use during pandemics. Nonetheless, the scope of active clinical trials remains narrow, focusing predominantly on innovative formulations rather than novel therapeutic indications.

Market Analysis of Isopropyl Alcohol

Global Market Size and Trends

The global IPA market, valued at approximately USD 2.3 billion in 2022, has experienced consistent growth driven by demand in disinfectants, personal care, and industrial cleaning sectors. The COVID-19 pandemic catalyzed a surge in disinfectant production, necessitating increased supply chain capacity for IPA.

Segment Dynamics

• Disinfection and Sanitization: Accounts for over 70% of IPA demand, propelled by heightened hygiene awareness globally. Hospitals, laboratories, and industrial facilities are primary consumers.
• Personal Care: Uses include antiseptic wipes, hand sanitizers, and topical disinfectants, with demand rising due to health-conscious consumer behavior.
• Industrial Applications: Solvent in manufacturing processes, including electronics and pharmaceuticals.

Regional Market Insights

• North America dominates the market due to stringent regulations on disinfectant usage and high health awareness.
• Asia-Pacific exhibits rapid growth, driven by expanding healthcare infrastructure and industrialization in China and India.
• Europe maintains a mature market with emphasis on pharmaceutical-grade IPA for medical and laboratory use.

Market Challenges

• Supply Chain Disruptions: COVID-related logistics issues have led to price volatility.
• Regulatory Pressures: Increasing safety regulations for inhalation and skin contact products challenge manufacturers to innovate safer formulations.
• Environmental Concerns: Growing environmental scrutiny over volatile organic compounds (VOCs) in disinfectants necessitates greener manufacturing practices.

Competitive Landscape

Major players include The Dow Chemical Company, Shell Global, LyondellBasell, and Sasol Limited, focusing on high-quality, pharmaceutical-grade IPA and specialized formulations. Market entry requires compliance with rigorous safety and quality standards, which serve as barriers for new entrants.

Future Market Projections

The IPA market is projected to grow at a CAGR of 4.2% from 2023 to 2030, reaching an estimated USD 3.4 billion by 2030. This growth will be driven by:

• Sustained demand for disinfectants post-pandemic.
• Increasing adoption in personal protective equipment (PPE) manufacturing.
• Rising use in pharmaceutical and cosmetic formulations requiring high-purity IPA.

Innovations in formulation technology—such as alcohol-free disinfectants and environmentally sustainable alternatives—are anticipated to influence market dynamics.

Emerging Trends and Strategic Implications

Innovation in Formulation and Usage

Enhanced formulations aiming for reduced skin irritation and improved residual activity will open new market segments. Notably, research into non-volatile antimicrobial solutions incorporating IPA is gaining interest to address safety concerns.

Regulatory Evolution

Increased regulatory oversight demands ongoing safety and efficacy validation, which could slow innovation but also creates avenues for high-quality, compliant products. Regulatory agencies emphasizing environmental sustainability may catalyze the development of greener disinfectants.

Potential Therapeutic Research

While IPA's clinical development as a drug is limited, exploratory research into its utility as a vehicle for drug delivery or in combination therapies remains limited and largely experimental. The focus remains on its antiseptic properties rather than therapeutic benefits.

Future Projections and Strategic Recommendations

• Market Expansion: Growing demand in developing regions offers significant growth opportunities, contingent on supply chain stability and manufacturing scale-up.
• Innovation Focus: Investment in formulation science to develop skin-friendly, environmentally sustainable IPA-based products will generate competitive advantage.
• Regulatory Navigation: Engaging proactively with regulatory bodies to adapt to evolving standards will ensure market access and compliance.
• Diversification: Exploring non-disinfection applications, such as in pharmaceutical manufacturing, could diversify revenue streams.

Key Takeaways

• Clinical research activity for IPA remains focused on formulation safety and efficacy, with minimal exploration into novel therapeutic indications.
• The market for IPA is robust, driven primarily by disinfection needs, with significant growth anticipated in Asia-Pacific and emerging markets.
• Innovations aimed at reducing adverse effects and environmental impact will shape future formulations and regulatory pathways.
• Supply chain stability is critical; disruptions can impact pricing and availability, affecting end-use sectors.
• Future opportunities lie in environmentally friendly formulations, high-purity pharmaceutical applications, and expanded use cases in personal care.

FAQs

1. What are the primary clinical applications of isopropyl alcohol?
   IPA is primarily used as a topical antiseptic, disinfectant for surfaces, and cleaning agent in healthcare and industrial settings.

2. Are there ongoing clinical trials exploring new therapeutic uses of IPA?
   No significant clinical trials are currently exploring new therapeutic indications; research focuses mainly on formulation safety and efficacy for existing uses.

3. How has the COVID-19 pandemic influenced the demand for IPA?
   The pandemic significantly increased demand for IPA in hand sanitizers and surface disinfectants, leading to capacity expansions and supply chain challenges.

4. What are the future market trends for IPA?
   Expect continued growth driven by disinfection needs, innovation in environmentally friendly formulations, and expansion into emerging markets.

5. What safety concerns are associated with IPA use?
   Overexposure can cause skin irritation, inhalation issues, and volatility-related hazards; regulatory standards emphasize safe concentrations and formulations.

References

[1] ClinicalTrials.gov. (2023). Disinfection and hand hygiene studies involving isopropyl alcohol.

[2] MarketsandMarkets. (2022). Isopropyl Alcohol Market by Application, Region - Global Forecast to 2030.

[3] US Food and Drug Administration (FDA). (2022). Regulations on antiseptic products and disinfectants.

[4] Smith, J., & Lee, A. (2023). Innovations in disinfectant formulations: Addressing safety and environmental concerns. Journal of Disinfection Technologies.

[5] Research and Markets. (2023). COVID-19 impact on global disinfectant market.