Ono Pharmaceutical Co., Ltd. announced that Glactiv (generic name: sitagliptin phosphate hydrate), an oral type-2 diabetes drug, has as of September 16, 2011 received approval for the additional indication of combination use with insulin products, the application for which was submitted in October 2010.

Glactiv was launched in December 2009 as the first DPP-4 (dipeptidyl peptidase-4) inhibitor in Japan. This drug, when administered once daily, selectively inhibits DPP-4, increases active incretin levels, and consequently enhances glucose-dependent insulin secretion to exert the hypoglycemic effect. This drug is not affected by food, and thus can be administered either before or after a meal.

Insulin products are widely used by patients with advanced type-2 diabetes. This approval, which will make available combination therapy with Glactiv and insulin products, can provide more diabetes treatment options.

Ono will actively provide information for proper use of Glactiv and its higher evaluation, and contribute to diabetes treatment in Japan.

Sitagliptin was co-developed for the Japanese market by Ono and Banyu Pharmaceutical Co., Ltd. (presently MSD) under the licensing agreement signed by Ono and Merck & Co., Inc., Whitehouse Station, New Jersey, USA in November 2004.

Glactiv (Ono) and Januvia (MSD) are the first selective DPP-4 (dipeptidyl peptidase-4) inhibitor launched in Japan.

Sitagliptin was launched in 2006 as the world’s first DPP-4 inhibitor in Mexico by Merck & Co., Inc., and has been approved in at least 98 countries with at least 20 million prescriptions dispensed.