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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: 29 Sep 2025

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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

  • 24 Sep 2025 Efficacy and adverse events data from the phase-III ConfIdeS trial for Renal transplant rejection released by Hansa Biopharma
  • 20 Jun 2025 Hansa Biopharma AB completes the phase-III ConfIdeS trial for Renal transplant rejection (Prevention, In adults, In the elderly) in USA (NCT04935177)
  • 11 Mar 2025 Hansa Biopharma AB announces intention to seek full authorization for Renal transplant rejection (Prevention)from the European Medicines Agency in European Union

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