Zydus Cadila seeks DCGI approval for novel oral pill to treat anaemia in kidney patients

Cadila Healthcare (Zydus Cadila), on Tuesday said it has submitted the New Drug Application (NDA) to the Drug Controller General of India (DCGI) seeking approval of its oral pill Desidustat, for treatment of anaemia in patients with Chronic Kidney Disease (CKD).

The pill technically called hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor can be given to both patients who are on dialysis and not on dialysis.

Desidustat is developed as an oral alternative to injectable erythropoietin-stimulating agents.


The company said the filing is based on data from two phase-3 clinical trials - DREAM-ND and DREAM-D that tested the drug in patients with CKD not on dialysis and on dialysis.

The DREAM-ND phase-3 trial of 588 CKD patients not-on-dialysis compared Desidustat versus Darbepoietin alpha injection. In the Desidustat group, mean hemoglobin (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.

Chronic Kidney Disease is a serious progressive medical condition which is a global unmet healthcare need involving gradual loss of functioning of kidneys eventually leading to kidney failure.

It has been reported that 114 million people in India are estimated to be living
with CKD.

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," said Pankaj R. Patel, Chairman, Cadila Healthcare

The company said Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed a good safety profile, endogenous production of erythropoietin, downregulation of hepcidin, and 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 such as American Journal of Nephrology, Clin Pharmacokinet, European Journal of Pharmacology, Journal of Medicinal Chemistry , Drug Dev Res, Drug Res (Stuttg) and Xenobiotica.