The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials  in patients with Chronic Kidney Disease (CKD) Not on Dialysis and on Dialysis.
   The DREAM-ND Phase III trial of 588 CKD patients not-on-dialysis compared Desidustat  versus Darbepoietin alpha 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 Darbepoetin in the treatment of anemia in patients  with CKD who were not on dialysis.  
 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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