CLINICAL TRIALS PROFILE FOR ALCOHOL 5% IN D5-W

505(b)(2) Clinical Trials for Alcohol 5% In D5-w

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 D5-w

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 D5-w

Condition Name

Condition Name for Alcohol 5% In D5-w
Intervention	Trials
Alcohol Use Disorder	212
Alcoholism	188
Alcohol Dependence	162
Alcohol Drinking	63

Condition MeSH

Condition MeSH for Alcohol 5% In D5-w
Intervention	Trials
Alcoholism	616
Alcohol Drinking	243
Disease	189
Depression	66

Clinical Trial Locations for Alcohol 5% In D5-w

Trials by Country

Trials by Country for Alcohol 5% In D5-w
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 D5-w
Location	Trials
California	194
Texas	142
New York	142
Connecticut	131
Maryland	125

Clinical Trial Progress for Alcohol 5% In D5-w

Clinical Trial Phase

Clinical Trial Phase for Alcohol 5% In D5-w
Clinical Trial Phase	Trials
PHASE4	30
PHASE3	29
PHASE2	69

Clinical Trial Status

Clinical Trial Status for Alcohol 5% In D5-w
Clinical Trial Phase	Trials
Completed	1163
Recruiting	341
Not yet recruiting	200

Clinical Trial Sponsors for Alcohol 5% In D5-w

Sponsor Name

Sponsor Name for Alcohol 5% In D5-w
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 D5-w
Sponsor	Trials
Other	2630
NIH	567
Industry	519

Alcohol 5% In D5-w Market Analysis and Financial Projection

Last updated: April 30, 2026

Alcohol 5% in D5W: Clinical Status, Market Read, and Projection

What is Alcohol 5% in D5W (and how is it used clinically)?

“Alcohol 5% in D5W” is an intravenous (IV) solution formulation of alcohol dosed at 5% (w/v basis as typically labeled) in dextrose 5% in water (D5W). In practice, the product is used in hospital settings for IV alcohol administration in specific clinical protocols, most commonly:

• Ethylene glycol or methanol poisoning (as an alternate substrate strategy to inhibit toxic alcohol metabolism)
• Hospital-based alcohol infusion protocols where an institutional pathway calls for IV ethanol

The relevant product scope is “Alcohol 5% in D5W,” not generic “ethanol for injection” broadly, because market access, supply chain, reimbursement, and regulatory categorization track the exact presentation and concentration.

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What is the clinical-trials picture for Alcohol 5% in D5W?

No complete and accurate, product-specific clinical trials dataset can be produced from the information provided. A proper “clinical trials update” requires a verifiable mapping of:

• exact investigational/marketed name (“Alcohol 5% in D5W” vs “ethanol in dextrose 5%” vs alternate labeling),
• route (IV),
• concentration (5% ethanol),
• and sponsor program timelines (Phases, endpoints, recruitment status).

With the current prompt alone, there is insufficient information to generate a complete, accurate, and cite-able trials update.

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What does the market look like today (buyers, channels, and demand drivers)?

A defensible market analysis also requires product-level substantiation (labeling, regulatory status, and documented availability) for “Alcohol 5% in D5W.” Without that, producing a complete and accurate market read risks conflating:

• compounded hospital supply versus manufactured pharmaceutical supply,
• ethanol concentration and diluent differences,
• and IV versus other ethanol forms (oral, inhaled, other dilutions).

That said, the demand drivers for IV ethanol in D5W-based protocols are structurally tied to:

• Acute toxic alcohol case volume (methanol and ethylene glycol events)
• Poison-center and ED treatment pathways (where ethanol is used)
• Hospital formulary decisions and IV protocol standardization
• Procurement reliability (when manufactured supply is constrained, institutions default to alternative sourcing)

But producing “hard data” market sizing, competitor mapping, pricing bands, and audited adoption metrics is not possible without product-specific evidence.

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Can we project volume and revenue for Alcohol 5% in D5W?

A complete and accurate projection requires baseline inputs such as:

• current US or ex-US market availability,
• number of eligible hospitals or ED/ICU beds adopting the protocol,
• per-case dosing conversion into ethanol 5% in D5W units,
• forecasted incident rates and adoption shifts,
• reimbursement and procurement pricing.

No such audited baseline inputs are provided. As a result, no complete and accurate projection can be produced.

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What is investable from a patent and development-control lens?

“Alcohol 5% in D5W” is commonly a low-cost, protocol-driven formulation where IP may be more limited than for novel therapeutics. For a business decision, the key IP questions are typically:

• Is the formulation covered by any composition-of-matter or method-of-use patents?
• Is there exclusivity tied to regulatory approval (if any manufactured product exists)?
• Are there stable manufacturing processes with protected process claims?

However, a patent map cannot be constructed accurately from the prompt alone. Delivering an investable view would require jurisdiction-specific patent retrieval by exact formulation name and synonyms.

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Key Takeaways

• A complete, accurate clinical-trials update, market analysis, and quantified projections for “Alcohol 5% in D5W” cannot be produced from the information given.
• Any attempt to quantify demand, pricing, competitors, or revenue trajectory would require product-specific identification and verifiable sources tied to the exact formulation and concentration.

FAQs

1. Is Alcohol 5% in D5W the same as IV ethanol for toxic alcohol poisoning?
   It can be, depending on the exact labeled concentration and diluent; “Alcohol 5% in D5W” is a specific presentation that must match clinical protocols.

2. Why does market sizing for this product vary across estimates?
   Most supply is often driven by hospital protocols and compounded or substituted procurement, which can break clean mapping to a single marketed product category.

3. What clinical endpoints would matter most if trials exist?
   Time-to-metabolic clearance and toxic alcohol metabolite reduction, plus clinical outcome measures used in poisoning pathways.

4. Is patent protection likely meaningful for this type of formulation?
   It can be limited; protection, if present, is usually formulation/process or method-of-use, not broad molecule-level exclusivity.

5. What determines whether hospitals adopt a specific ethanol dilution?
   Protocol requirements, pharmacy workflow compatibility, procurement reliability, and alignment with institutional toxicology guidance.

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References

[1] No sources cited.