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M 021

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Drug Profile

M 021

Alternative Names: M-021

Latest Information Update: 18 Jul 2025

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At a glance

  • Originator M6P Therapeutics
  • Class Alpha-glucosidases; Enzymes; Recombinant proteins
  • Mechanism of Action Alpha-glucosidase replacements; Enzyme replacements
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical Glycogen storage disease type II

Most Recent Events

  • 18 Jul 2025 M6P Therapeutics plans to submit IND for Glycogen storage disease type II by third quarter of 2026 (M6P Therapeutics pipeline, July 2025)
  • 18 Jul 2025 Pharmacodynamics data from a preclinical trial in Pompe disease released by M6P Therapeutics (M6P Therapeutics pipeline, July 2025)
  • 09 Feb 2023 M 021 receives Rare pediatric drug status for Glycogen storage disease type II in USA prior to February 2023 (M6P Therapeutics website, February 2023)

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