CLINICAL TRIALS PROFILE FOR ANTIZOL

All Clinical Trials for ANTIZOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00661141 ↗	Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism	Completed	Ted Daley, President	Phase 2	2008-04-01	This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.
NCT00661141 ↗	Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism	Completed	Horizon Pharma USA, Inc.	Phase 2	2008-04-01	This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.
NCT00661141 ↗	Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism	Completed	Raptor Pharmaceuticals Inc.	Phase 2	2008-04-01	This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.
NCT00346853 ↗	Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy	Completed	University of Utah	Phase 1	2005-11-01	The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body's ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients' vision, and may also have similar effects in other macular degenerative diseases.

Clinical Trial Conditions for ANTIZOL

Condition Name

Condition Name for ANTIZOL
Intervention	Trials
Acetaldehyde Toxicity	1
Aldehyde Dehydrogenase-2 (ALDH2) Deficiency	1
ALDH2 Deficiency	1
Altered Ethanol Metabolism	1

Condition MeSH

Condition MeSH for ANTIZOL
Intervention	Trials
Stargardt Disease	1
Macular Degeneration	1
Corneal Dystrophies, Hereditary	1

Clinical Trial Locations for ANTIZOL

Trials by Country

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−

Trials by Country for ANTIZOL
Location	Trials
United States	3

Trials by US State

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−

Trials by US State for ANTIZOL
Location	Trials
Hawaii	1
California	1
Utah	1

Clinical Trial Progress for ANTIZOL

Clinical Trial Phase

Clinical Trial Phase for ANTIZOL
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ANTIZOL
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for ANTIZOL

Sponsor Name

Sponsor Name for ANTIZOL
Sponsor	Trials
Raptor Pharmaceuticals Inc.	1
University of Utah	1
Ted Daley, President	1

Sponsor Type

Sponsor Type for ANTIZOL
Sponsor	Trials
Industry	2
Other	2

ANTIZOL (Fomepizole): Clinical Trials, Market Analysis, and Projections

Introduction

ANTIZOL, also known as fomepizole, is a critical antidote used in the treatment of ethylene glycol and methanol poisoning. Here, we will delve into the clinical trials, market analysis, and future projections for this essential medication.

Clinical Trials and Efficacy

Ethylene Glycol and Methanol Intoxication Studies

The efficacy of ANTIZOL in treating ethylene glycol and methanol intoxication has been extensively studied in several clinical trials. Two prospective U.S. clinical trials demonstrated that ANTIZOL effectively blocks the metabolism of ethylene glycol and methanol by inhibiting the alcohol dehydrogenase enzyme. These studies showed that ANTIZOL prevented the rise in plasma concentrations of toxic metabolites such as glycolate and formate, even when used in conjunction with hemodialysis[4].

Animal Studies

Animal studies have also supported the efficacy of ANTIZOL. For example, in dogs administered ethylene glycol, fomepizole given 3 hours after ingestion attenuated metabolic acidosis and prevented renal tubular damage. Similar results were observed in monkeys, where ANTIZOL concentrations of approximately 10 μmol/L were sufficient to inhibit methanol metabolism to formate[4].

Human Clinical Trials

In human clinical trials, 14 out of 16 patients in the ethylene glycol trial and 7 out of 11 patients in the methanol trial underwent hemodialysis in addition to ANTIZOL therapy. Despite the confounding effects of hemodialysis and ethanol concentrations, ANTIZOL alone was shown to block the rise in toxic metabolite concentrations in the post-dialysis periods[4].

Market Analysis

Current Market Size and Growth

The market for antidotes like ANTIZOL, while not as large as other pharmaceutical segments, is part of a broader critical care market. However, specific market size data for ANTIZOL is not readily available. Instead, we can look at the broader context of emergency and critical care medications.

Demand Drivers

The demand for ANTIZOL is driven by the need for effective treatments for ethylene glycol and methanol poisoning, which can be life-threatening. The increasing incidence of accidental or intentional ingestions of these substances contributes to the steady demand for this antidote.

Competitive Landscape

ANTIZOL is a unique product with no direct competitors for its specific indication. Its efficacy and safety profile make it a standard treatment in emergency medicine. However, the overall market for critical care and emergency medications is competitive, with various pharmaceutical companies developing and marketing different antidotes and treatments.

Market Projections

General Trends in Critical Care Medications

The global market for critical care medications, including antidotes like ANTIZOL, is expected to grow due to increasing healthcare needs and advancements in medical treatments. While specific projections for ANTIZOL are not available, the broader critical care market is anticipated to see steady growth.

Regional Market Analysis

North America, particularly the United States, is a significant market for critical care medications due to advanced healthcare infrastructure and high incidence rates of various poisonings. The market in this region is expected to continue growing, driven by the need for effective emergency treatments[5].

Future Outlook

Continued Use and Development

Given its proven efficacy, ANTIZOL is likely to remain a crucial component in the treatment of ethylene glycol and methanol poisoning. Ongoing research and clinical trials may further refine its use and dosing regimens, potentially expanding its applications.

Regulatory and Safety Considerations

ANTIZOL is classified under Pregnancy Category C, indicating that its effects on pregnant women are not well understood. Future studies may focus on clarifying these aspects to ensure broader safety profiles. Additionally, interactions with other medications, such as those involving cytochrome P450 enzymes, will continue to be a focus of research[4].

Key Takeaways

• Efficacy: ANTIZOL is highly effective in blocking the metabolism of ethylene glycol and methanol, preventing the formation of toxic metabolites.
• Clinical Trials: Prospective U.S. clinical trials and animal studies have supported its use in treating poisoning cases.
• Market Analysis: While specific market data for ANTIZOL is limited, it is part of a growing critical care market driven by increasing healthcare needs.
• Future Outlook: ANTIZOL is expected to remain a vital antidote, with ongoing research aimed at refining its use and safety profile.

FAQs

What is ANTIZOL used for?

ANTIZOL (fomepizole) is used as an antidote for ethylene glycol (such as antifreeze) and methanol poisoning.

How does ANTIZOL work?

ANTIZOL works by inhibiting the alcohol dehydrogenase enzyme, thereby blocking the metabolism of ethylene glycol and methanol into their toxic metabolites.

What are the key findings from clinical trials of ANTIZOL?

Clinical trials have shown that ANTIZOL effectively prevents the rise in plasma concentrations of toxic metabolites of ethylene glycol and methanol, even when used in conjunction with hemodialysis.

Is ANTIZOL safe during pregnancy?

ANTIZOL is classified under Pregnancy Category C, meaning its effects on pregnant women are not well understood, and it should be used with caution.

What are the potential interactions of ANTIZOL with other medications?

ANTIZOL can interact with medications that affect the cytochrome P450 enzymes, and it also interacts with ethanol, affecting the elimination rates of both substances.

What is the future outlook for ANTIZOL in the market?

ANTIZOL is expected to continue as a critical antidote, with ongoing research focusing on refining its use and safety profile.

Sources

1. Antizol (fomepizole) Injection - Product Monograph[1].
2. ANTIZOL® (fomepizole) Injection - FDA Label[4].
3. Global Antifungal Drugs Market - While not directly related to ANTIZOL, this report provides context on the broader pharmaceutical market trends[5].