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Tralesinidase alfa - BioMarin Pharmaceutical

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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: 18 Mar 2026

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At a glance

  • Originator BioMarin Pharmaceutical
  • Class Acetylglucosaminidases; Growth factors; 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

  • 09 Mar 2026 Spruce Biosciences announces intention to submit Biologics License Application (BLA) to the US FDA for Tralesinidase alfa for Mucopolysaccharidosis III in the fourth quarter of 2026
  • 31 Jan 2026 Spruce Biosciences attends positive Type B meetings with US FDA for Tralesinidase Alfa for Mucopolysaccharidosis-III
  • 08 Oct 2025 Spruce Biosciences plans to launch tralesinidase alfa for mucopolysaccharidosis type IIIb in the US in late 2026

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