Roxadustat is under clinical development by FibroGen and currently in Phase III for Anemia. According to GlobalData, Phase III drugs for Anemia have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Roxadustat’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.

Roxadustat overview

Roxadustat (Ai Ruizhuo, Evrenzo) is an anti-anemic agent. It is formulated as tablets, capsules and film coated tablets for oral route of administration. It is indicated for the treatment of anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent (DD), and who are not dialysis-dependent (NDD). Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

Roxadustat (FG-4592, ASP1517) is under development for the treatment of anemia associated with chronic kidney disease (CKD) in patients not on dialysis and on dialysis and end stage renal disease (ESRD) and anemia in lower risk myelodysplastic syndromes (MDS), chemotherapy induced anemia . It is administered orally. It was also under development for the treatment of sickle cell disease.

FibroGen overview

FibroGen is a biopharmaceutical company that discovers, and develops medicines for the treatment of anemia, cancer, and fibrotic disease. Its approved product includes roxadustat for the treatment of treatment of anemia associated with chronic kidney disease, in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) patients. Its pipeline product includes pamrevlumab (FG-3019) for the treatment of idiopathic pulmonary fibrosis (IPF), duchenne muscular dystrophy (DMD); ELUMINEX for the treatment of Corneal Blindness. The company is also evaluating pamrevlumab in Phase II for investigating its safety and efficiency in patients with COVID-19. The company has operations in the US, Hong Kong, Finland, Cayman Islands and China. FibroGen is headquartered in San Francisco, California, the US.

For a complete picture of Roxadustat’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.