The drug discussed below is for the treatment of type 2 diabetes.
The Food and Drug Administration has given Cadila Healthcare the go-ahead to conduct U.S. trials of its ZYGK1 drug for treating diabetes.
Cadila is a pharmaceutical company based in Ahmedabad, in India’s Gujarat state. The firm does business in 90 countries.
ZYGK1 is an orally administered drug that acts as a glucose sensor in the pancreas and regulates glucose metabolism in the liver. It is considered a “new molecular entity,” a chemical that has not been seen before in drugs. Because of its newness, an NME undergoes particularly intense scrutiny to prove its effectiveness and safety.
At this time, neither Cadila nor the FDA has given specifics about how the U.S. tests will proceed.