Banyu/Ono start Ph III trial of sitagliptin

Japanese drugmakers Banyu and Ono have initiated a domestic Phase III clinical evaluation of the antidiabetes drug sitagliptin with a new mechanism of dipeptidyl peptidase-IV inhibition. The agent, which received its first approval this week in Mexico, was originated by US drug major Merck & Co, Banyu's parent, and is sold under the brand name Januvia.

The investigational oral, once-daily drug is the first to compete in the emerging DPP-IV inhibitor market, which Banc of America analysts predict could achieve peak annual sales of $3.0 billion by 2010. Merck presented data at the the 2006 annual meeting of the American Diabetes Association demonstrating that sitagliptin is non-inferior to glipizide and significantly reduces blood glucose levels when used alone or with metformin or pioglitazone (Marketletter June 19).