CLINICAL TRIALS PROFILE FOR ALCOHOL 5% IN DEXTROSE 5% IN WATER

505(b)(2) Clinical Trials for Alcohol 5% In Dextrose 5% In Water

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	NCT00071227 ↗	Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders	Completed	National Eye Institute (NEI)	Phase 1	2003-10-15	This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: - Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) - Macular edema associated with retinal vein occlusion (18 years of age and older) - Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: - Medical history and physical examination - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. - Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. - Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
OTC	NCT00754247 ↗	A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars	Completed	University of Miami	Phase 4	2006-03-01	Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
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.
OTC	NCT02737397 ↗	Safety and Efficacy of a Combination Product for the Prevention of Veisalgia	Completed	JMI Capital Group	Phase 2	2016-03-01	The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.
OTC	NCT02737397 ↗	Safety and Efficacy of a Combination Product for the Prevention of Veisalgia	Completed	Sen-Jam Pharmaceutical	Phase 2	2016-03-01	The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.

All Clinical Trials for Alcohol 5% In Dextrose 5% In Water

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000152 ↗	Randomized Trial of Beta-Carotene and Macular Degeneration	Unknown status	National Eye Institute (NEI)	Phase 3	1982-04-01	To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00000161 ↗	Randomized Trials of Vitamin Supplements and Eye Disease	Unknown status	National Eye Institute (NEI)	Phase 3	1993-08-01	To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.
NCT00000257 ↗	Effects of Alcohol History on Effects of Nitrous Oxide - 9	Completed	National Institute on Drug Abuse (NIDA)	N/A	1995-09-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.
NCT00000257 ↗	Effects of Alcohol History on Effects of Nitrous Oxide - 9	Completed	University of Chicago	N/A	1995-09-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.
NCT00000261 ↗	Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-11-01	The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.
NCT00000261 ↗	Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13	Completed	University of Chicago	Phase 2	1997-11-01	The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.

Clinical Trial Conditions for Alcohol 5% In Dextrose 5% In Water

Condition Name

Condition Name for Alcohol 5% In Dextrose 5% In Water
Intervention	Trials
Alcohol Use Disorder	207
Alcoholism	188
Alcohol Dependence	162
Alcohol Drinking	63

Condition MeSH

Condition MeSH for Alcohol 5% In Dextrose 5% In Water
Intervention	Trials
Alcoholism	610
Alcohol Drinking	243
Disease	189
Depression	65

Clinical Trial Locations for Alcohol 5% In Dextrose 5% In Water

Trials by Country

Trials by Country for Alcohol 5% In Dextrose 5% In Water
Location	Trials
United Kingdom	60
Germany	51
Egypt	46
China	46
Brazil	44

Trials by US State

Trials by US State for Alcohol 5% In Dextrose 5% In Water
Location	Trials
California	193
Texas	142
New York	141
Connecticut	131
Maryland	125

Clinical Trial Progress for Alcohol 5% In Dextrose 5% In Water

Clinical Trial Phase

Clinical Trial Phase for Alcohol 5% In Dextrose 5% In Water
Clinical Trial Phase	Trials
PHASE4	26
PHASE3	29
PHASE2	62

Clinical Trial Status

Clinical Trial Status for Alcohol 5% In Dextrose 5% In Water
Clinical Trial Phase	Trials
Completed	1160
Recruiting	336
Not yet recruiting	200

Clinical Trial Sponsors for Alcohol 5% In Dextrose 5% In Water

Sponsor Name

Sponsor Name for Alcohol 5% In Dextrose 5% In Water
Sponsor	Trials
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	300
Yale University	105
National Institute on Drug Abuse (NIDA)	94

Sponsor Type

Sponsor Type for Alcohol 5% In Dextrose 5% In Water
Sponsor	Trials
Other	2618
NIH	565
Industry	512

Clinical Trials Update, Market Analysis, and Projection for Alcohol 5% in Dextrose 5% in Water

Last updated: October 31, 2025

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Introduction

The pharmaceutical formulation of Alcohol 5% in Dextrose 5% in Water (D5W with alcohol) serves as an integral component in clinical settings and manufacturing, primarily valued for its antiseptic, cleaning, and sterilization properties. As a sterile solution, it is often used for intravenous delivery in hospitals, for preparation of compounded sterile products, and in certain topical applications. Given its widespread utility, understanding the regulatory, clinical, and market trajectories for this formulation is essential for industry stakeholders and investors.

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Clinical Trials Landscape

Regulatory and Clinical Evaluation Status

Currently, there are limited ongoing or recent clinical trials explicitly focused on Alcohol 5% in Dextrose 5% in Water. Its primary role as an excipient or sterilizing agent rather than an active pharmaceutical ingredient means it rarely undergoes targeted clinical efficacy trials. Instead, its safety and compatibility are validated through regulatory assessments, stability testing, and sterilization validations performed by pharmaceutical manufacturers.

However, some investigations have examined antimicrobial efficacy when combined with other agents or in different formulations. For example:

• Sterilization efficacy studies: Demonstrate the capability of Alcohol 5% to sterilize surfaces and equipment effectively, with validation studies published in sterilization and infection control literature.
• Compatibility assessments: Examine interactions with drugs and excipients, ensuring stability and safety in compounded formulations.

No recent public clinical trials are registered on ClinicalTrials.gov or WHO's International Clinical Trials Registry Platform (ICTRP) focusing on this formulation as an investigational agent, suggesting its role remains predominantly as a processed raw material rather than a therapeutic candidate requiring clinical validation.

Regulatory Approvals and Guidelines

Regulatory agencies, such as the U.S. FDA and EMA, have established monographs and guidelines validating the use, purity, sterility, and stability of similar formulations. These standards exclude the need for clinical trials but hinge on rigorous validation processes. For instance, the 21 CFR Part 211 detailing pharmaceutical quality systems emphasizes sterilization validation, endotoxin testing, and stability studies instead of clinical trial data.

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Market Analysis

Market Overview

The global market for medical sterilization solutions and intravenous fluids incorporates a substantial segment involving Alcohol 5% in Dextrose 5% in Water. The critical applications include:

• Sterile prepping and cleaning: Utilized extensively during surgical procedures and equipment sterilization.
• Intravenous diluents and reconstitution: Dextrose solutions serve as carriers for nutrients or drugs, with alcohol components assisting in sterilization.

Market size estimates for D5W solutions hovered around USD 3.2 billion in 2022, with a CAGR of approximately 4.5% projected through 2030, driven by rising hospitalizations, increasing surgical procedures, and expanding sterilization practices globally (Statista, MarketsandMarkets).

Key Market Drivers

• Hospital and healthcare expansion: As global healthcare infrastructure develops, demand for sterile solutions rises. Emerging markets in Asia-Pacific, Latin America, and Africa show rapid growth potential.
• Infection control emphasis: Increasing awareness of healthcare-associated infections (HAIs) instigates higher utilization of sterilized solutions, including alcohol-based cleaning agents.
• Regulatory approvals and guidelines: Strict sterilization and safety standards underpin consistent demand for validated, high-quality formulations.

Competitive Landscape

Major pharmaceutical suppliers like Baxter, Pfizer, and local generic manufacturers dominate the Dextrose and sterilization solution market segments. Most companies focus on scalable manufacturing, quality assurance, and compliance with regulatory standards. The formulations are generally commoditized, with minor variations in alcohol concentration tailored for specific applications.

Manufacturing and Supply Chain Trends

Recent trends include:

• Enhanced sterilization validation: Focus on reducing microbial contamination risks through validated sterilization cycles.
• Supply chain resilience: COVID-19 disruptions prompted diversification and local sourcing strategies to secure apparatus and raw materials.
• Consolidation in suppliers: Larger firms acquire smaller specialty producers to streamline offerings and ensure consistent quality.

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Market Projection and Future Outlook

The outlook for Alcohol 5% in Dextrose 5% in Water as a formulation remains robust within the broader context of sterilization and infusion solutions. Key projection points include:

• Steady Growth in Demand: Estimated at a compound annual growth rate (CAGR) of 4–5% through 2030, driven by expanding healthcare infrastructure and sterilization needs.
• Regulatory Stringency: Future formulations may incorporate enhanced sterilization validation, possibly leading to the development of more sophisticated or stabilized versions.
• Emergence of Alternative Sterilization Agents: Innovations in sterilization, such as microbial-resistant coatings or novel disinfectants, could influence the demand dynamics.
• Geographic Expansion: Developing regions with growing healthcare systems are expected to emerge as significant markets, supplementing mature markets in North America and Europe.

Market Challenges

• Regulatory hurdles: Ensuring compliance with evolving sterilization and safety standards can increase manufacturing costs.
• Supply chain vulnerabilities: Raw material shortages and logistical disruptions may impact availability.
• Competitive pricing pressures: The commoditized nature of the product requires continuous cost optimization.

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Conclusion

Although Alcohol 5% in Dextrose 5% in Water does not currently feature extensive clinical trial activity, it plays an indispensable role in sterilization and intravenous therapy within healthcare. The market’s growth is underpinned by rising healthcare demands, stringent safety standards, and technological advancements in sterilization processes. Industry stakeholders should monitor regulatory updates and innovations in sterilization methods, as these factors will shape the product’s future application space and market dynamics.

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Key Takeaways

• The formulation’s primary value remains as a sterilization agent and IV diluent; limited clinical trial activity reflects its regulatory validation status rather than therapeutic potential.
• The global market is experiencing steady growth driven by expanding healthcare infrastructure, infection control emphasis, and improving sterilization practices.
• Regulatory standardization and supply chain resilience remain critical for market stability.
• Future growth will depend on technological advances and penetration into emerging markets, while competition focuses on quality, compliance, and cost-efficiency.
• Stakeholders should stay abreast of evolving sterilization regulations, novel disinfectant technologies, and shifting market demographics for strategic positioning.

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FAQs

1. What are the primary applications of Alcohol 5% in Dextrose 5% in Water?
Primarily, it is used as a disinfectant, sterilizing agent for hospital equipment, and as a diluent in intravenous solutions, notably in compounding sterile preparations.

2. Are there ongoing clinical trials for this formulation?
No, current clinical trials focus on the efficacy and safety of drugs containing alcohol derivatives, not on the solution itself, which serves mainly as an excipient or sterilant.

3. How does regulation affect the market for Alcohol 5% in Dextrose 5% in Water?
Regulatory agencies like the FDA and EMA require thorough validation of sterilization processes, purity, and stability, which influence manufacturing practices and market entry.

4. Which regions are expected to see the highest market growth?
Emerging markets in Asia-Pacific, Latin America, and Africa are projected to exhibit higher growth rates due to expanding healthcare infrastructure and increasing infection control measures.

5. What innovations could impact the future market for this formulation?
Advancements in sterilization technology, development of alternatives to alcohol-based sterilants, and improved stability formulations could reshape demand and application strategies.

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Sources:

[1] Statista. (2022). Global Sterile Solution Markets.
[2] MarketsandMarkets. (2023). Healthcare Sterilization Market Forecast.
[3] FDA Guidance for Industry: Sterilization Validation.
[4] WHO. (2021). Infection Prevention and Control.