WHO names Zydus oral anemia developmental candidate: Pankaj Patel
Ahmedabad: Zydus Cadila announced that the WHO INN committee has granted the name Desidustat to its Phase II anemia candidate, ZYAN1. The INN system aims to provide healthcare professionals with a unique and universal designated name for each pharmaceutical substance.
Anemia is a global public health problem affecting both developing and developed countries. Anemia commonly arises in kidney disease patients, because the kidneys no longer produce sufficient amounts of erythropoietin, a hormone which stimulates red blood cell production. Symptoms of anemia may include fatigue, skin pallor, shortness of breath, light-headedness, dizziness or a fast heartbeat. The Global ESA Market is estimated at USD 7 billion worldwide.
“In keeping with our mission of creating healthier communities globally, it is our constant endeavor to develop therapies that bridge unmet healthcare needs. Desidustat which is currently in phase 2 clinical trials, strengthens this commitment with an aim to provide treatment to millions of patients suffering from anemia” said, Mr. Pankaj Patel, Chairman, Zydus Cadila.
Desidustat is an oral small molecule that has been designed to inhibit hypoxia-inducible factor prolyl hydroxylase and thereby increase the natural production of hemoglobin and RBCs in anemic patients. The molecule has been shown to improve iron mobilization and has the potential to reduce or eliminate the need for iron supplementation. Desidustat has the potential to bring about a paradigm shift in the management of patients with anemia as it could provide an oral, safer alternative to currently available erythropoietin stimulating agents (ESAs), which are associated with an increased risk of CV events, and must be given via injections.
Two phase I trials of ZYAN1 have been concluded in Australia and India, and results have been published in several peer-reviewed journals. ZYAN1 was safe and well-tolerated in healthy volunteers following single escalating oral doses (10–300 mg) and multiple escalating oral doses (100–300 mg). The measurement of serum erythropoietin (EPO) levels in healthy volunteers confirmed the pharmacodynamic effect as EPO increased with increasing ZYAN1 doses in relation to placebo. Zydus is currently conducting phase 2 clinical trials for Desidustat to treat anemia in CKD patients.