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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: 02 Sep 2026

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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

  • Marketed Niemann-Pick disease type C
  • Preregistration Ataxia telangiectasia
  • Phase III Migraine; Spinocerebellar ataxias; Type 2 episodic ataxia
  • Phase II Sandhoff disease; Tay-Sachs disease

Most Recent Events

  • 17 Aug 2026 Phase-III clinical trials in Migraine (In children, In adolescents, In adults, In the elderly) in Germany, USA, United Kingdom, Switzerland, Italy, Austria (PO) (NCT07221292)
  • 17 Aug 2026 Phase-III clinical trials in Spinocerebellar ataxias (In children, In adolescents, In adults, In the elderly) in United Kingdom, Switzerland, Italy, Germany, Austria, USA (PO) (NCT07221292)
  • 17 Aug 2026 Phase-III clinical trials in Type-2 episodic ataxia (In children, In adolescents, In adults, In the elderly) in USA, United Kingdom, Switzerland, Italy, Germany, Austria (PO) (NCT07221292)

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