Last update 01 Mar 2025

Levacetylleucine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
N-Acetyl-L-Leucine, IB-1001, IB1001
+ [1]
Action-
Mechanism
calcium channel modulators(Calcium Channel modulators)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (24 Sep 2024),
RegulationOrphan Drug (United States), Priority Review (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Niemann-Pick Disease, Type C
United States
24 Sep 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ataxia TelangiectasiaPhase 3
United States
01 Mar 2025
Ataxia TelangiectasiaPhase 3
Germany
01 Mar 2025
Ataxia TelangiectasiaPhase 3
Slovakia
01 Mar 2025
Ataxia TelangiectasiaPhase 3
Spain
01 Mar 2025
Ataxia TelangiectasiaPhase 3
Switzerland
01 Mar 2025
Sandhoff DiseasePhase 2
United States
07 Jun 2019
Sandhoff DiseasePhase 2
Germany
07 Jun 2019
Sandhoff DiseasePhase 2
Spain
07 Jun 2019
Sandhoff DiseasePhase 2
United Kingdom
07 Jun 2019
Tay-Sachs DiseasePhase 2
United States
07 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
60
bqveziqpcz(dqvymzlzmo) = oiweyrnysa gbwyxrwnwu (ynxhxversk, 0.1)
Positive
24 Sep 2024
Placebo
bqveziqpcz(dqvymzlzmo) = nocqxjuhgy gbwyxrwnwu (ynxhxversk, 0.1)
Phase 2
30
vdsjlziqkt(mthilyjmkj) = statistically significant change. 90% CI: 0.00, 1.50, p-value = 0.039 hlzvqrwozo (fzpploqhsy )
Positive
14 Sep 2021
Phase 2
32
N-acetyl-L-leucine
xtaxtnxwoj(wowhsmjybw) = NALL met the CI-CS primary endpoint (mean difference 0.86, SD = 2.52, 90% CI 0.25, 1.75, p = 0.029) vkfinpmeoc (grjeuosxng )
Positive
13 Aug 2021
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Approval

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Regulation

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