alogliptin

The news raises the likelihood that the U.S. authorities won't approve SYR-322, which is also known as alogliptin, later this year as Takeda and analysts previously expected.

Takeda Diabetes Drug Dealt a Blow 2009

Its SYR-322, also known by the general name alogliptin, is the single-most important drug in the Japanese pharmaceutical maker's development pipeline.

Takeda's Diabetes Drug Delayed 2009

Deutsche Securities maintained its "hold" rating on the issue but lowered its target price to 3,600 yen from 4,500 yen, saying that the additional trials required for SYR-322, known as alogliptin, will push back the drug's launch by two years.

unknown title 2009

Takeda Pharmaceutical Co. said the FDA set a June 26, 2009, deadline for its diabetes drug alogliptin after failing to meet an Oct. 27, 2008, date.

FDA Approved More Drugs in 2008 2009

Added June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, We are pleased Takeda has taken this important step toward obtaining regulatory approval of alogliptin in the United States.

unknown title 2011

An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of Type 2 diabetes.

unknown title 2011

An NDA for the alogliptin/pioglitazone fixed-dose combination was approved in June 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of Type 2 diabetes.

unknown title 2011

Alogliptin/pioglitazone is a fixed dose combination therapy in development for the treatment of Type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet.

unknown title 2011

"Throughout its development, we have believed in the ability of alogliptin to contribute to improving the health of diabetes patients," said Fred Eshelman, Pharm.

unknown title 2011

"The achievement of the resubmission of the NDAs for alogliptin and alogliptin/pioglitazone confirms the value of alogliptin to patients and to our partner, Takeda."

unknown title 2011