Zydus Cadila announces Phase-III trials of anemia drug Desidustat

Pharmaceutical manufacturer Zydus Cadila announced phase-III trials of the Desidustat, an investigational new drug and a Hypoxia-Inducible Factor (HIF) Prolyl Hydroxylase (PH) enzyme inhibitor used for the treatment of anemia and chronic kidney disease.

HIF-PH inhibitors are a new class of agents for the treatment of anemia in chronic kidney disease patients.

Chronic Kidney Disease (CKD) is a medical condition involving gradual loss of functioning of kidneys, eventually leading to kidney failure. In chronic kidney disease, the kidneys fail to produce Erythropoietin or EPO and this leads to low levels of hemoglobin (Hb) in the blood or anemia.

Desidustat is also known as ZYAN 1 and ZYAN 1-1001 tablets.

“The Phase III study will be a multicenter (50- 60 sites), randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anaemia in patients with chronic kidney disease (CKD) who are not on dialysis”, Zydus said.

Darbepoetin is used for the treatment of anemia, commonly associated with chronic renal failure and cancer chemotherapy. It is marketed by Amgen under the trade name Aranesp.

“This innovation has the potential to bring about a paradigm shift in the management of CKD patients with anemia. An HIF-PH inhibitor could provide an oral, safer alternative to currently available erythropoietin stimulating agents (ESAs), which are associated with increased risk of cardiovascular events and have to be given via injections”, said Pankaj R. Patel, Chairman, Zydus Group.

Desidustat had met its primary endpoints in the Phase II clinical study of Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD) patients suffering from anemia. The Phase I trials of the drug were completed in Australia.

Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim, the United States and Brazil.