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ACG 801

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Drug Profile

ACG 801

Alternative Names: ACG-801; Recombinant human acid ceramidase- Sumitomo Pharma America; RVT-801

Latest Information Update: 28 Mar 2026

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At a glance

  • Originator Icahn School of Medicine at Mount Sinai
  • Developer Aceragen
  • Class Ceramidases
  • Mechanism of Action Acid ceramidase replacements
  • Orphan Drug Status

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

    Yes - Farber lipogranulomatosis
  • New Molecular Entity No

Highest Development Phases

  • Phase III Farber lipogranulomatosis
  • No development reported Cystic fibrosis

Most Recent Events

  • 28 Mar 2026 No recent reports of development identified for preclinical development in Cystic-fibrosis in USA (Inhalation)
  • 13 Apr 2023 Aceragen has patent protection for certain compositions, method of making and methods of use with respect to acid ceramidase and ACG 801 in USA, Europe, Japan, Israel, Mexico, and Hong-Kong
  • 13 Apr 2023 Aceragen has patent protection for claims related to certain methods of treating infections in patients with cystic fibrosis, chronic obstructive pulmonary disease, or an open wound using acid ceramidase and ACG 801 in USA, Europe, Hong-Kong, and Japan

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