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N-Acetyl-L-Leucine - IntraBio

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Drug Profile

N-Acetyl-L-Leucine - IntraBio

Alternative Names: IB-1001 - IntraBio

Latest Information Update: 11 Jun 2024

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At a glance

  • Originator University of Munich; University of Oxford
  • Developer IntraBio
  • Class Acetamides; Amino acids; Esters; Neuroprotectants; Pentanoic acids; Small molecules; Vestibular disorder therapies
  • Mechanism of Action Calcium channel modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Tay-Sachs disease; Niemann-Pick disease type C; Ataxia telangiectasia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Niemann-Pick disease type C
  • Phase II Ataxia telangiectasia; Sandhoff disease; Tay-Sachs disease

Most Recent Events

  • 13 Apr 2024 Efficacy and adverse events data from a phase III trial in Niemann-Pick disease type C presented at the 76th Annual Meeting of the American Academy of Neurology 2024 (AAN-2024)
  • 14 Aug 2023 IntraBio plans to file for marketing authorization with N-Acetyl-L-Leucine with the US FDA and EMA
  • 14 Aug 2023 Efficacy and adverse events data from a phase III trial in Niemann-Pick disease type C released by IntraBio

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