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Acetylleucine - IntraBio

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Drug Profile

Acetylleucine - IntraBio

Alternative Names: Acetyl-DL-leucine - IntaBio; Acetyl-leucine - IntraBio; IB 1000; IBI1000; N-Acetyl-DL-leucine - IntraBio

Latest Information Update: 27 Feb 2026

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At a glance

  • Originator University of Munich; University of Oxford
  • Developer IntraBio
  • Class Acetamides; Amino acids; Esters; 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; Niemann-Pick disease type B; Niemann-Pick disease type A
  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 27 Feb 2026 9461053- updated KDM, added FE, there is no such term CACNA1A Disorders even in mesh
  • 25 Feb 2026 IntraBio receives positive European Medicines Agency opinion for Orphan Medicinal Product Designation for CACNA1A disorders
  • 24 Feb 2026 IntraBio anticipates grant of an Orphan Medicinal Product Designation for CACNA1A disorders from EMA in second quarter of 2026

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