Drug Profile
Alpha galactosylceramide liposomal - REGiMMUNE
Alternative Names: KRN-7000 liposomal; liposomal KRN-7000; liposomal RGI-7000; RGI 3100; RGI-2001; RGI7000 liposomal; ToleroVaxLatest Information Update: 03 May 2023
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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