Zydus seeks DCGI approval for Desidustat to treat anaemia in kidney patients

 The DREAM-D Phase III trial of 392 CKD patients on Dialysis compared Desidustat tablet versus Epoetin alfa injection. In the Desidustat group, mean Hb increased and reached the predefined target of 10.0–12.0 g/dl in patients and was maintained within the target range for 24 weeks. The study demonstrated the noninferiority of Desidustat compared to Epoetin in the treatment of anemia in patients with CKD who were on dialysis.

Desidustat met its primary efficacy endpoint in both Phase 3 trials, DREAM-ND and DREAM-D, conducted in Chronic Kidney Disease (CKD) patients on Dialysis and Not on Dialysis. The data will be presented at upcoming scientific meetings and published in peer-reviewed scientific journals.

"We are excited by this important milestone and thankful to all the patients, investigators, regulators and scientists, who led the discovery and development of Desidustat over the last decade. Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilisation. With patient-centricity at the core of all that we do, we have been looking at innovative approaches to improving the quality of life of patients and bridging unmet needs and with Desidustat we have taken yet another step in this direction. " said, Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd.

Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile, endogenous production of erythropoietin, downregulation of hepcidin, improved iron mobilization in CKD patients. The Phase I trials were earlier completed in Australia. Desidustat is also under clinical trials for Cancer Chemotherapy Induced Anemia (CIA).

The data of Desidustat (ZYAN1) has so far been published in various peer-reviewed scientific journals of repute such as American Journal of Nephrology, Clin Pharmacokinet, European Journal of Pharmacology, Journal of Medicinal Chemistry , Drug Dev Res, Drug Res (Stuttg) and Xenobiotica.

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