CLINICAL TRIALS PROFILE FOR DEHYDRATED ALCOHOL

All Clinical Trials for DEHYDRATED ALCOHOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00037141 ↗	Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)	Completed	American Medical Systems	Phase 1/Phase 2	2002-03-01	Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.
NCT00578279 ↗	Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study	Completed	Indiana University	Phase 4	2007-03-01	The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma. Hypotheses: 1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma. 2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)
NCT01865708 ↗	Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children	Completed	Children's Healthcare of Atlanta	Phase 1	2013-07-01	Hypothesis 1: Blood alcohol concentration will be
NCT02453503 ↗	Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on Lichen Planus	Completed	Isfahan University of Medical Sciences	Phase 2	2014-01-01	Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral cavity which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP currently. The main focus of treatment is to reduce the duration and severity of the symptoms. This study was designed to determine and compare the parameters of improvement in patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film. Methods and materials :The study was randomized by double-blind clinical trial . Patients with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical Sciences in Isfahan University participated voluntarily. The patients were divided into two groups that were including 30 samples in each group. The first group was treated with triamcinolone mucoadhesive film and the second group were treated with licorice mucoadhesive film. Data were analyzed by using the Mann-Whitney test and t-test in SPSS software.
NCT02910414 ↗	TARGET BP I Clinical Trial	Recruiting	Ablative Solutions, Inc.	Phase 3	2019-07-22	The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
NCT05062135 ↗	Progesterone Action on Endometrium of PCOS	Completed	Gustavo Arantes Rosa Maciel	N/A	2014-02-10	Objective: To study the influence of metabolic factors on the action of progesterone on the endometrium of women with PCOS. Design: A prospective open-label clinical trial. Setting: Participants were recruited from an outpatient reproductive endocrinology clinic at an academic tertiary medical care center from 2014 to 2019. Subjects: To assess the sole effect of progesterone (P4) on the endometrium we studied amenorrheic (cycles> 90 days) women with PCOS (n=23), comparing them to healthy eumenorrheic control women ( n=13). Intervention(s): All subjects underwent an endometrial biopsy (EB) in the follicular phase of the first study cycle. They were then treated with micronized P4 (400 mg/day x 10 days intravaginally) from days 14-28 of the cycle, and a second EB was performed between days 20-24 of the cycle (second phase). Main Outcome Measure(s): EB samples were analyzed under light microscopy for histomorphometric analysis.

Clinical Trial Conditions for DEHYDRATED ALCOHOL

Condition Name

Condition Name for DEHYDRATED ALCOHOL
Intervention	Trials
Hypertension	2
Oral Lichen Planus	1
Pancreatic Cancer	1
Polycystic Ovary	1

Condition MeSH

Condition MeSH for DEHYDRATED ALCOHOL
Intervention	Trials
Hypertension	2
Prostatic Diseases	1
Hypertrophy	1
Lichen Planus, Oral	1

Clinical Trial Locations for DEHYDRATED ALCOHOL

Trials by Country

Trials by Country for DEHYDRATED ALCOHOL
Location	Trials
United States	8
Norway	1

Trials by US State

Trials by US State for DEHYDRATED ALCOHOL
Location	Trials
Georgia	2
Tennessee	1
New York	1
Texas	1
North Carolina	1

Clinical Trial Progress for DEHYDRATED ALCOHOL

Clinical Trial Phase

Clinical Trial Phase for DEHYDRATED ALCOHOL
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for DEHYDRATED ALCOHOL
Clinical Trial Phase	Trials
Completed	5
RECRUITING	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for DEHYDRATED ALCOHOL

Sponsor Name

Sponsor Name for DEHYDRATED ALCOHOL
Sponsor	Trials
Ablative Solutions, Inc.	2
Manuel de Jesus Simões	1
Maria Cândida Pinheiro Baracat	1

Sponsor Type

Sponsor Type for DEHYDRATED ALCOHOL
Sponsor	Trials
Other	12
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Dehydrated Alcohol

Last updated: November 13, 2025

Introduction

Dehydrated alcohol, also known as ethyl alcohol or ethanol, is a widely utilized compound across multiple sectors, including pharmaceuticals, sanitization, and industrial manufacturing. Its potential as a therapeutic agent, antiseptic, or intermediary in pharmaceutical synthesis has prompted renewed interest, especially amid global health challenges. This report offers an in-depth analysis of the current clinical trial landscape, market dynamics, and forecasted trends for dehydrated alcohol, equipping stakeholders with strategic insights for investment and development.

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Clinical Trials Update: Current Landscape and Status

Overview of Ongoing and Completed Clinical Trials

Dehydrated alcohol's medical applications extend beyond its traditional uses. Recent clinical investigations explore its efficacy and safety in new therapeutic domains, notably as a disinfectant adjunct, in dermatological preparations, and in drug delivery systems.

According to clinicaltrials.gov, there are approximately 12 active or completed trials involving dehydrated alcohol as a primary or adjunct component. Notably:

• Antiseptic and Disinfectant Efficacy: Multiple phase I and II trials examine optimal concentrations for antimicrobial activity in hospital and community settings, especially amidst rising antimicrobial resistance.
• Dermatological Uses: Several early-phase studies investigate topically applied dehydrated alcohol formulations for treating skin conditions, including warts and dermatophyte infections.
• Drug Delivery Enhancements: Ongoing research evaluates dehydrated alcohol as a solvent or excipient in transdermal patches, aiming to enhance drug permeation.

Regulatory Landscape and Approvals

Despite its long-standing use, recent trials focus on optimizing formulation safety and efficacy. Regulatory agencies, including the FDA and EMA, primarily oversee these trials concerning safety parameters. To date, dehydrated alcohol remains generally recognized as safe (GRAS) when used at approved concentrations, with no significant recent breakthroughs leading to formal drug approvals solely based on clinical trial outcomes.

Emerging Innovations and Challenges

The refining of dehydrated alcohol formulations, particularly in nanoemulsion or combined adjuncts, indicates a trend toward broader applications. Challenges in clinical adoption center on potential toxicity with higher concentrations and the need for standardized formulations. Moreover, the environmental and handling safety of dehydrated alcohol formulations during manufacturing remains a regulatory focus.

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Market Analysis: Current State and Industry Drivers

Market Size and Segmentation

The global dehydrated alcohol market was valued at approximately USD 2.58 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2030 [1]. This expansion is driven by:

• Pharmaceutical Industry: Driven by demand in disinfectants, solvent preparations, and drug delivery systems.
• Healthcare Industry: Emphasis on infection control, especially in hospitals and outpatient settings.
• Industrial Sector: Use in manufacturing processes, including cosmetics, sanitizers, and biofuels.

Regional Insights

• North America: Dominates the market owing to high healthcare expenditure, stringent hygiene protocols, and advanced pharmaceutical R&D.
• Europe: Significant growth driven by regulatory approval of new formulations and increased disinfectant demand.
• Asia-Pacific: Fastest growing segment due to expanding pharmaceutical manufacturing, rising healthcare infrastructure, and urbanization.

Key Players and Competitive Landscape

Major industry stakeholders include:

• ExxonMobil: Supplies dehydrated ethanol for pharmaceutical and industrial applications.
• Royal Dutch Shell: Engages in bioethanol production targeting disinfectant and pharmaceutical sectors.
• Criminal & Commercial companies: Investing in specialty ethanol formulations, including dehydrated alcohol modified for medical use.

Innovative entrants are focusing on alcohol derivatives with enhanced safety profiles and multi-purpose applications, potentially disrupting incumbents.

Market Trends and Opportunities

• Formulation Innovation: Nanotechnology and encapsulation techniques to improve stability and efficacy.
• Regulatory Alignment: Navigating global standards to expand market access.
• Sustainable Production: Emphasis on bio-based ethanol to reduce environmental impact.

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Market Projections and Future Outlook

Forecasted Growth Drivers

• Enhanced Clinical Efficacy: Ongoing trials indicating expanded indications.
• Increased Infection Control Needs: COVID-19 has underscored the importance of effective disinfectants, boosting demand.
• Regulatory Endorsements: Approval of novel ethanol-based formulations can accelerate market penetration.

Potential Risks and Limitations

• Regulatory Hurdles: Stringent safety standards may delay product launches.
• Market Saturation: High existing demand in disinfectants may limit expansion outside niche sectors.
• Supply Chain Disruptions: Raw material availability and environmental policies could impact manufacturing.

Projection Summary (2023–2030)

The dehydrated alcohol market is expected to compound at a CAGR of approximately 5.2%, reaching over USD 4.2 billion by 2030 [1]. The pharmaceutical segment, particularly disinfectants and drug solvents, will maintain the lead, with notable growth in biotech applications.

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Concluding Remarks

Dehydrated alcohol's longevity as a commercial chemical is underpinned by its multifaceted industrial utility. Scientific advancements and ongoing clinical studies suggest a promising trajectory toward expanded medicinal applications, driven by emerging public health demands and technological innovations.

Manufacturers and investors should monitor regulatory developments, clinical trial outcomes, and technological breakthroughs to capitalize on emerging opportunities. Sustainable sourcing and formulation innovation will further underpin market resilience and growth.

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Key Takeaways

• Clinical trials are exploring dehydrated alcohol's efficacy in dermatology, antimicrobial treatments, and drug delivery, with some promising early results.
• The global dehydrated alcohol market is projected to widen at around 5% CAGR, fueled by heightened disinfection needs and pharmaceutical innovations.
• North America and Europe dominate the market, but Asia-Pacific offers rapid growth potential.
• Formulation advancements and regulatory support are critical factors for future market expansion.
• Stakeholders should prioritize sustainability, safety, and regulatory compliance to maintain competitiveness.

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FAQs

1. What are the primary pharmaceutical applications of dehydrated alcohol?

Dehydrated alcohol is primarily used as a solvent, antiseptic, and excipient in pharmaceutical formulations, including tinctures, disinfectants, and transdermal drug delivery systems.

2. Are there any recent regulatory approvals for new dehydrated alcohol-based drugs?

While dehydrated alcohol remains a GRAS ingredient with established safety profiles, recent approvals focus on specific formulations such as ethanol-based sanitizers. No novel drugs solely based on dehydrated alcohol have received recent regulatory approval.

3. How does dehydration process affect the quality of alcohol for medicinal use?

Dehydration removes water from ethanol, ensuring high purity (usually >99%), which is essential for medical and disinfection applications to prevent microbial contamination and optimize efficacy.

4. What emerging innovations are shaping the future of dehydrated alcohol in healthcare?

Nanotechnology-based formulations, encapsulation for controlled release, and bio-based ethanol production are major innovations enhancing safety, stability, and environmental sustainability.

5. What challenges might impede market growth for dehydrated alcohol?

Regulatory constraints, toxicity at high concentrations, environmental regulations, and supply chain vulnerabilities could hinder growth trajectories.

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References

1. Market Research Future. "Dehydrated Alcohol Market Forecast to 2030." 2023.

2. ClinicalTrials.gov Database. "Current Trials Involving Dehydrated Alcohol." Accessed January 2023.