Zydus begins Phase-II trials for its new anaemia drug Zyan1

Developed drug, an oral molecule, is the latest new chemical entity from the firm's pipeline

Ahmedabad-based drug major Cadila Healthcare (Zydus Cadila) on Wednesday announced that it had initiated its second phase of trials to investigate Zyan1, an oral molecule used to treat anaemia associated with chronic kidney disease (CKD). 

The development comes from the company's new chemical entity (NCE) pipeline. Currently, Zydus Cadila has a pipeline of four NCEs, of which three are new and one is already under trial. The country's first NCE- Lipaglyn (Saroglitazar)- was developed in-house by Zydus. The drug is currently approved in India as the prescribed medicine for the treatment of hypertriglyceridemia and diabetic dyslipidemia. It is usually prescribed to patients suffering from type-2 diabetes, which is not controlled by statins. In India, Saroglitazar was launched in September 2013. 

Already, three indications of Lipaglyn have been approved for the phase-II trials in the United States of America (US). 

Zyan1 is an oral small molecule that has been designed to increase the natural production of haemoglobin and red blood cells (RBCs) in anaemic patients. Zyan1 has been shown to improve iron mobilisation and has the potential to reduce or eliminate the need for iron supplements.

“We have observed the desired pharmacokinetic and safety profile in addition to positive signals in biomarker responses, including erythropoietin increase with Zyan1 in the two phase-I trials that were conducted in Australia and India,” said Pankaj Patel, chairman and managing director, Zydus Cadila.

He added that Zyan1 has the potential to bring about a paradigm shift in the management of patients with anaemia as it could provide an oral, safer alternative to currently available erythropoietin-stimulating agents (ESAs), which are associated with an increased risk of cardio vascular events, and must be given via injections. 

Currently, the Global ESA market is estimated to stand at $7 billion.

Patients suffering from a kidney disease are said to be afflicted with anaemia, as their kidneys are unable to produce the sufficient amount of erythropoietin- a hormone which stimulates red blood cell production. Symptoms of anaemia may include fatigue, skin pallor, shortness of breath, light-headedness, dizziness or a fast heartbeat.