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.

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.

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	212
Alcoholism	188
Alcohol Dependence	162
Alcohol Drinking	63

Condition MeSH

Condition MeSH for Alcohol 5% In Dextrose 5% In Water
Intervention	Trials
Alcoholism	616
Alcohol Drinking	243
Disease	189
Depression	66

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
China	49
Egypt	47
Brazil	44

Trials by US State

Trials by US State for Alcohol 5% In Dextrose 5% In Water
Location	Trials
California	194
Texas	142
New York	142
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	30
PHASE3	29
PHASE2	69

Clinical Trial Status

Clinical Trial Status for Alcohol 5% In Dextrose 5% In Water
Clinical Trial Phase	Trials
Completed	1163
RECRUITING	341
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)	302
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	2630
NIH	567
Industry	519

Alcohol 5% In Dextrose 5% In Water Market Analysis and Financial Projection

Last updated: April 23, 2026

Alcohol 5% In Dextrose 5% In Water: Clinical Development, Market Readout, and Projection

What is “Alcohol 5% in Dextrose 5% in Water” in drug-development terms?

“Alcohol 5% in dextrose 5% in water” is a compounded intravenous (IV) solution defined by composition rather than by a single proprietary active pharmaceutical ingredient (API) label. In practice, “alcohol” in IV formulations most often refers to ethanol used for solubilization or stabilization of another drug substance, or as part of a compounding vehicle. “Dextrose 5% in water” (D5W) is a standard IV carrier.

Because the term describes a formulation vehicle and concentration rather than a named, regulator-approved finished product with a unique INN/brand and sponsor, no single global clinical-trial record or market authorization line item can be attributed to the formulation label alone without a specific drug name (the embedded active, if any) or a sponsor/NDC.

As a result, this update is limited to what can be stated as composition-defined and formulation-vehicle driven, not as a stand-alone “drug” with a unified clinical pipeline.

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Are there clinical trials for this exact formulation as a standalone investigational product?

No complete clinical-trials identification can be produced from the formulation description alone.

Clinical trial registries (e.g., ClinicalTrials.gov, EU CTR) index investigational drugs by the sponsor’s product name, the IND application, the active ingredient, and protocol identifiers. “Alcohol 5% in Dextrose 5% in Water” is not sufficient to uniquely match a single investigational agent, phase, indication, or endpoint set. Without a specific drug context (what ethanol is for, what molecule it carries, and the sponsored product identifier), the registry search cannot be mapped to one tractable clinical program.

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Does this formulation have market authorization value on its own?

No, it does not. Market authorization and market sizing are typically attached to a licensed finished product (active ingredient plus dosage form plus strengths, with a specific sponsor/MAH) or a compounding standard tied to a particular compounding protocol.

A vehicle formulation like:

• Ethanol at 5% (v/v or w/v depending on source, which materially changes dosing and safety characterization)
• Dextrose 5% in water (D5W)

does not itself define a unique product category for commercial analytics unless it is coupled to a named drug substance (the intended IV drug therapy) or a regulated product license.

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Practical R&D and Commercial Implications (Vehicle-Driven, Not Pipeline-Defined)

How investors and R&D teams typically treat ethanol-in-D5W formulation lines

In hospital and compounding workflows, ethanol-in-D5W solutions often exist as:

• a solubilizer for poorly water-soluble drugs
• a stabilizer for certain formulations
• a component of a larger IV regimen where the clinical value belongs to the drug, not the vehicle

This means the clinical and commercial “unit” is usually the drug product that uses this formulation strategy, not the vehicle itself.

What you can project from formulation composition alone

A defensible projection can only be built from demand for:

• the underlying ethanol-containing drug therapy
• the specific dosage and route strategy that uses ethanol and D5W as a vehicle
• substitution patterns (alternative solvents, alternate carriers, ready-to-use vs compounding)

Without identifying the associated active drug, no credible numerical market forecast can be generated.

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Market Analysis Framework That Applies (But Needs Drug Identity to Quantify)

How market projection is typically built for ethanol-containing IV therapies

A standard model requires:

• Target indication incidence or treated population
• Prescribing share by line of therapy
• Conversion to IV administrations per patient per year
• Unit pricing based on regulated product pricing or compounded cost model
• Penetration adjustment for ready-to-use vs compounding and solvent-switch risks

For an ethanol-in-D5W composition, the governing variables are tied to the embedded active drug and its clinical positioning.

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Key Takeaways

• “Alcohol 5% in Dextrose 5% in Water” is a formulation description and does not map cleanly to a single regulator-defined product, sponsor, or clinical-trial program.
• No standalone clinical-trials update or numeric market projection can be produced from the formulation label alone because trials and commercial analytics are indexed by product identity, not by solvent/carrier concentration.
• Any actionable projection must anchor to the specific active pharmaceutical ingredient and the licensed or investigational product that uses ethanol in D5W as its vehicle.

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FAQs

1) Is “Alcohol 5% in D5W” a finished drug product?

No. It is a formulation vehicle description unless it is tied to a named, authorized finished product or a specific protocol compounding standard.

2) Can ClinicalTrials.gov be searched reliably using only this formulation label?

Not reliably. Trial records require a sponsor product name/IND/drug substance linkage; “alcohol 5% in D5W” is not a unique investigational product identifier.

3) Is market size driven by ethanol-in-D5W composition?

Usually not. Market demand is driven by the underlying therapeutic drug and its dosing regimen; the vehicle affects manufacturability and stability, not the clinical demand origin.

4) What makes ethanol-in-IV formulations commercially sensitive?

Availability of manufacturing inputs, stability data, regulatory acceptance of solvent system, and substitution by alternative solvents or delivery systems.

5) What is the fastest way to make this projection investable?

Tie the formulation to the specific embedded drug substance and product identifier so trials, approvals, and pricing inputs can be mapped to the correct unit economics.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Union Clinical Trials Register. https://www.clinicaltrialsregister.eu/