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Imlifidase - Hansa Biopharma

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Drug Profile

Imlifidase - Hansa Biopharma

Alternative Names: EnzE programme - Hansa Biopharma AB; Enzyme-based antibody enhancement programme - Hansa Biopharma AB; HMed-IdeS; IDEFIRIX; Idefirix; IdeS; IgG-degrading enzyme of Streptococcus pyogenes; IgG-endopeptidase; Mac-1; Streptococcal cysteine proteinase

Latest Information Update: 09 Apr 2026

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At a glance

  • Originator Hansa Medical AB
  • Developer Asklepios BioPharmaceutical; Hansa Biopharma AB; Sarepta Therapeutics
  • Class Antibacterials; Antineoplastics; Antirheumatics; Bacterial proteins; Endopeptidases; Immunotherapies
  • Mechanism of Action Immunoglobulin G degraders; Immunosuppressants
  • Orphan Drug Status

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

    Yes - Anti-glomerular basement membrane disease; Guillain-Barre syndrome; Transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Renal transplant rejection
  • Phase III Anti-glomerular basement membrane disease
  • Phase II Anti-neutrophil cytoplasmic antibody-associated vasculitis; Crigler-Najjar syndrome; Guillain-Barre syndrome; Thrombotic thrombocytopenic purpura
  • Phase I Duchenne muscular dystrophy
  • Preclinical Autoimmune disorders; Glycogen storage disease type II
  • No development reported Cancer; Limb girdle muscular dystrophies
  • Discontinued Rheumatoid arthritis; Streptococcal infections

Most Recent Events

  • 26 Mar 2026 Hansa Biopharma announces intention to launch to imlifidase in Renal transplant rejection in USA
  • 04 Mar 2026 FDA assigns PDUFA action date of 19/12/2026 for Imlifidase for Renal transplant rejection
  • 18 Feb 2026 The US FDA accepts Biologics License Application (BLA) for imlifidase for Renal transplant rejection (Prevention) for review

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