The latest progress of Daprodustat as well as global marketing trends and clinical research directions

Daprodustat is an innovative oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF‑PHI), mainly used to treat anemia related to chronic kidney disease (CKD). Its core mechanism of action is to promote erythropoiesis and improve iron metabolism by stabilizing hypoxia-inducible factor (HIF) levels, thereby increasing hemoglobin levels. Different from traditional erythropoiesis stimulating agents (ESA), daplestat is easy to take orally and can reduce the frequency of injections. It may also reduce the risk of some vascular events and provide patients with new treatment options.

In terms of global marketing, daprostat has been approved for marketing in Japan under the trade name Duvroq, and is used for the treatment of anemia in non-dialysis and dialysis-dependent CKD patients. Clinical trial data show that the drug can effectively maintain hemoglobin levels, while the incidence of adverse reactions is comparable to traditional treatments. Japan’s marketing experience provides regulatory reference and clinical practice data for other countries, which will help advance the subsequent approval process.

In the United States, the FDA has approved daprostat (trade name Jesduvroq ) for use in patients with dialysis-dependent renal anemia, the first oral HIF‑PHI drugs provide a new option for non-injection treatment for patients who are long-term dependent on dialysis. The European Medicines Agency (EMA) has also accepted its marketing application and given a positive expert opinion, laying the foundation for future accessibility in Europe. The overseas launch makes this new oral treatment option available to more patients around the world.

In terms of clinical research, daplestat is undergoing a number of global III phase clinical trials (such as ASCEND‑ND and ASCEND‑D), to evaluate its efficacy and safety in non-dialysis and dialysis-dependent CKD patients, including endpoints such as hemoglobin improvement and incidence of adverse cardiovascular events. In addition, some real-world studies are also being conducted to observe its long-term effects and dosage adjustment strategies, providing important data support for future global promotion and clinical application. These findings suggest that daprostat has the potential to become a standard oral option in the treatment of anemia in chronic kidney disease.

Keyword tags: dapoprimostat, latest progress, global launch, HIF-PHI, renal anemia, chronic kidney disease, oral treatment, clinical trial.

Reference materials:https://pubmed.ncbi.nlm.nih.gov/?term=daprodustat