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Alpha galactosylceramide liposomal - REGiMMUNE

Drug Profile

Alpha galactosylceramide liposomal - REGiMMUNE

Alternative Names: KRN-7000 liposomal; liposomal KRN-7000; liposomal RGI-7000; RGI 3100; RGI-2001; RGI7000 liposomal; ToleroVax

Latest Information Update: 03 May 2023

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At a glance

  • Originator REGiMMUNE
  • Developer JDRF; Pfizer; REGiMMUNE
  • Class Adjuvants; Antineoplastics; Galactosylceramides; Small molecules
  • Mechanism of Action Blood coagulation factor replacements; Enzyme replacements; Galactosylceramidase replacements; Immunosuppressants; Natural killer T cell stimulants; Regulatory T-lymphocyte modulators
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Graft-versus-host disease
  • No development reported Type 1 diabetes mellitus
  • Discontinued Haemophilia; Lysosomal storage diseases

Most Recent Events

  • 03 Apr 2023 Regimmune Corporation completes a phase IIb trial for Graft-versus-host disease (Prevention, Combination therapy) in USA (IV) (NCT04014790)
  • 01 Apr 2023 RGI 2001 licensed to San Fu Biotech (SFB) in major Asian countries for the prophylaxis of acute Graft-versus-host disease (aGvHD)
  • 01 Apr 2023 REGiMMUNE announces intention to submit a phase III IND application to the US FDA for acute Graft-versus-host disease in Q4 of 2023
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