ZYDUS CADILA FILES FOURTH IND IN INDIA

Zydus Cadila has filed an investigational new drug (IND) application for a new molecular entity -- ZYO1, a new drug candidate for treating obesity and related disorders -- with the Drugs Controller General (DCGI) of India.

ZYO1 is a novel experimental drug working through CB-1 mechanism, which will help obese patients lose weight, and also in controlling blood sugar levels in those with Type 2 diabetes, according to the company. The drug could also have a role in protecting the heart.

The recently concluded preclinical studies on ZYO1 have reported encouraging findings that indicate a good safety profile, the company said. The only other drug in the CB-1 class that has gained approval is Rimonabant, and since its approval, the diet drug has been clouded with controversy due to its side effects like nausea, vomiting and an increase in psychiatric liabilities, according to Zydus.

The company plans to initiate Phase I clinical trials to ensure the safety and tolerability of ZYO1. Once the safety of the drug is established the company plans to develop it further to treat various cardiometabolic risk factors in patients with obesity and prove its beneficial effects in improving HbA1c, HDL-cholesterol, triglycerides and systolic blood pressure, and reducing waist circumference.