Zydus Cadila, a leading healthcare company, has filed the IND application for ZYTI - a novel lipid lowering molecule with the US FDA. Designed and developed at its Research Centre, ZYTI is a novel, anti-dyslipidemic agent which may provide an alternative to statins or be an add-on to statin therapy.
Dyslipidemia is a clinical condition characterized by an elevation of cholesterol and/or triglycerides in the bloodstream. Over 80 per cent of patients with coronary heart disease, even hose currently on medication, remain above the targeted levels of cholesterol.
Pankaj Patel, chairman and managing director, said, "This is an important milestone in the new drug discovery initiatives that are being undertaken at our Research Centre. With ZYTI entering the phase-I clinical trials, it holds promising commercial potential as a future blockbuster due to unmet medical needs and absence of effective treatments in dyslipidemia patients."
The group has already filed an IND for ZYTI in India and is currently in Phase I clinical trials. ZYTI has demonstrated beneficial effect on LDL cholesterol and triglycerides, comparable to the effects seen with statins. When combined with statins, ZYTI exhibited a pronounced effect in lowering LDL cholesterol and triglycerides with the added benefit of a very high margin of safety.
The Zydus Research Centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation therapeutic areas. With over 375 research professionals spearheading its NME research programme, it has in house capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof- of concept clinical trials.