RGI-2001 is under clinical development by REGiMMUNE and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect RGI-2001’s likelihood of approval (LoA) and phase transition for Graft Versus Host Disease (GVHD) took place on 19 Jul 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their RGI-2001 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

RGI-2001 overview

RGI-2001 is under development for the prevention of graft versus host disease (GvHD) associated with hematopoietic stem cell transplantation (HSCT). The drug candidate is administered intravenously. RGI-2001 is a proprietary liposomal formulation of a synthetic derivative of alpha-galactosylceramide. The drug candidate is developed based on reVax (reverse vaccination) technology platform. It was also under development for the treatment of Hepatitis B and solid tumor including lung cancer, hemophilia, lysosomal storage disorder an multiple myeloma.

REGiMMUNE overview

REGiMMUNE is a bio pharmaceutical company. It develops solutions for treating immune disorders caused by nonspecific and excessive immune reactions. The company’s products pipeline includes GvHD and TID. It offers reverse vaccination technologies such as reVax induces treg, immune tolerance, reVax formulation, and others. Inaddition, REGiMMUNE also provides technology for immune system disorders and diseases. The company’s products are used for the treatment of hematopoiesis, leukemia, hematopoietic stem cell transplantation, graft versus host disease, human leukocyte antigens, type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus, among others. It has operations in the US and Japan. REGiMMUNE is headquartered in Tokyo, Japan.

Quick View RGI-2001 LOA Data

Report Segments
  • Innovator
Drug Name
  • RGI-2001
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: REGiMMUNE
  • Originator: Kirin Brewery
Highest Development Stage
  • Phase II


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.