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Levacetylleucine - IntraBio

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Drug Profile

Levacetylleucine - IntraBio

Alternative Names: AQNEURSA; IB-1001 - IntraBio; N-Acetyl-L-Leucine - IntraBio

Latest Information Update: 07 Nov 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

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

Most Recent Events

  • 04 Nov 2024 IntraBio plans a phase III trial for Ataxia telangiectasia (In children, In adolescents, In adults, In elderly) in the US, Germany, Slovakia, Spain and Switzerland (PO, Suspension) in March 2025 (NCT06673056)
  • 24 Sep 2024 Registered for Niemann-Pick disease type C (In adolescents, In children, In adults) in USA (PO)
  • 24 Sep 2024 FDA assigns PDUFA action date of (24/09/2024) for levacetylleucine for Niemann-Pick disease type C (IntraBio pipeline, September 2024)

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