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Tralesinidase alfa - BioMarin Pharmaceutical

Drug Profile

Tralesinidase alfa - BioMarin Pharmaceutical

Alternative Names: Alpha-N-acetyglucosaminidase-insulin-like-growth-factor-2 fusion protein; AX-250; BMN 250; NAGLU-IGF2 fusion protein; TA-ERT - BioMarin Pharmaceutical

Latest Information Update: 15 May 2025

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At a glance

  • Originator BioMarin Pharmaceutical
  • Class Acetylglucosaminidases; Recombinant fusion proteins
  • Mechanism of Action Alpha N acetyl D glucosaminidase replacements
  • Orphan Drug Status

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

    Yes - Mucopolysaccharidosis III
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Mucopolysaccharidosis III

Most Recent Events

  • 07 May 2025 Spruce plans to launch Tralesinidase alfa in Latin America, Turkey, Asia, and other international markets
  • 06 May 2025 Tralesinidase alfa - BioMarin Pharmaceutical receives Fast Track designation for Mucopolysaccharidosis III [Intracerebral] (In children, In infants) in USA prior to May 2025
  • 06 May 2025 Tralesinidase alfa - BioMarin Pharmaceutical receives Priority Medicine (PRIME) status for Mucopolysaccharidosis III in European Union prior to May 2025

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