City-based pharmaceutical major, Zydus Cadila announced completion of the single ascending dose (SAD) study of ZYAN1 molecule as part of phase-1 study ongoing in Australia. The molecule, ZYAN1 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being developed for the treatment of anemia, the company informed in a statement here.

ZYAN1 has been designed to increase the natural production of erythropoietin (EPO) in anemic patients and match the efficacy of injectible EPO stimulating agents, it said.

The first-in-man, double blind, multi-centric study of the molecule is underway in Australia. The multiple dosing studies are expected to be completed by second quarter of 2015, the company informed.

Anemia is a condition of having lower red blood cells or lower haemoglobin levels than is normal. Anemia is a serious medical condition linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). 

"This is an important innovation that will radically change the treatment paradigm in anemia," said Pankaj Patel, Chairman and Managing Director, Zydus Cadila. 

"ZYAN1 has the potential to become an oral therapy for treating patients with anemia with significant advantages over currently available injectable EPO stimulating agents (ESAs)," he added.

Currently available agents for the treatment of anemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. The estimated global market for treatments for anemia related to CKD is $ 10 billion.

The Phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of ZYAN1 in healthy volunteers, the company said.

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