Zydus Cadila has announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India for Desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anaemia in patients with Chronic Kidney Disease (CKD), according to a stock exchange filing

“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 erythropoietinstimulating 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, Pankaj R. Patel, Chairman, Cadila Healthcare Ltd.

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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)

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