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Last Updated: January 3, 2025

CLINICAL TRIALS PROFILE FOR FOMEPIZOLE


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All Clinical Trials for fomepizole

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02415712 ↗ Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance) Recruiting Takeda 2015-01-27 The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for fomepizole

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Acetaldehyde ToxicityLiver FailureAcetaminophenLiver Toxicity[disabled in preview]
Condition Name for fomepizole
Intervention Trials
Acetaldehyde Toxicity 1
Liver Failure 1
Acetaminophen 1
Liver Toxicity 1
[disabled in preview] 0
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Condition MeSH

21110-0.200.20.40.60.811.21.41.61.822.2PoisoningMacular DegenerationCorneal Dystrophies, HereditaryLiver Failure[disabled in preview]
Condition MeSH for fomepizole
Intervention Trials
Poisoning 2
Macular Degeneration 1
Corneal Dystrophies, Hereditary 1
Liver Failure 1
[disabled in preview] 0
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Clinical Trial Locations for fomepizole

Trials by Country

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Trials by Country for fomepizole
Location Trials
United States 4
Japan 1
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Trials by US State

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Trials by US State for fomepizole
Location Trials
Arizona 1
Hawaii 1
California 1
Utah 1
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Clinical Trial Progress for fomepizole

Clinical Trial Phase

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 2Phase 1Early Phase 1[disabled in preview]
Clinical Trial Phase for fomepizole
Clinical Trial Phase Trials
Phase 2 2
Phase 1 1
Early Phase 1 1
[disabled in preview] 0
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Clinical Trial Status

60.0%20.0%20.0%000.511.522.53CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for fomepizole
Clinical Trial Phase Trials
Completed 3
Recruiting 1
Not yet recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for fomepizole

Sponsor Name

trials000111112222University of UtahTed Daley, PresidentHorizon Pharma USA, Inc.[disabled in preview]
Sponsor Name for fomepizole
Sponsor Trials
University of Utah 1
Ted Daley, President 1
Horizon Pharma USA, Inc. 1
[disabled in preview] 2
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Sponsor Type

50.0%50.0%000.511.522.533.54OtherIndustry[disabled in preview]
Sponsor Type for fomepizole
Sponsor Trials
Other 4
Industry 4
[disabled in preview] 0
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