FDAnews Drug Daily Bulletin

Takeda Ends Development of Fasiglifam for Type 2 Diabetes

Jan. 2, 2014

Japanese drugmaker Takeda has decided to end all trials of its investigational type 2 diabetes treatment TAK-875 (fasiglifam) after new data revealed the drug’s benefits could not overcome potential liver safety risks. The company initiated its Phase III trial program in October 2011.

The decision was made after consulting with outside clinical investigators, Takeda said.

The drugmaker is asking investigators to follow instructions laid out in a safety alert, as well as closely monitor trial patients for signs of hyperglycemia.

Discovered by Takeda, fasiglifam was the first GPR40 agonist to reach Phase III development. Initial findings indicated that the drug candidate had a glucose-lowering effect in patients with type 2 diabetes by stimulating glucose-dependent insulin secretion.

The company did not return requests for comment by press time Tuesday. — Lena Freund