FR-104 is under clinical development by Veloxis Pharmaceuticals and currently in Phase I for Kidney Transplant Rejection. According to GlobalData, Phase I drugs for Kidney Transplant Rejection have a 93% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how FR-104’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

FR-104 overview

FR-104 is under development for the treatment of autoimmune disorders including, rheumatoid arthritis, multiple sclerosis, psoriasis, uveitis, graft versus host disease (GVHD) and prevention of transplantation rejection including kidney transplantation and stem cell transplantation. It is administered intravenously and subcutaneously. It is a monovalent pegylated Fab fragment of a humanised anti-CD28 monoclonal antibody. The drug candidate is a new molecular entity (NME).

Veloxis Pharmaceuticals overview

Veloxis Pharmaceuticals (Veloxis Pharma), a subsidiary of Veloxis Pharmaceuticals AS is a fully integrated pharmaceutical company committed to improving the lives of transplant patients. Veloxis Pharma is headquartered in Cary, North Carolina, the US.

For a complete picture of FR-104’s drug-specific PTSR and LoA scores, buy the report here.


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.