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ARTICLE | Clinical News

Takeda presents Phase III data for TAK-438

May 7, 2014 11:24 PM UTC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) presented data from five Japanese Phase III trials of the pharma's vonoprazan fumarate ( TAK-438), a small molecule potassium competitive acid blocker, at the Digestive Disease Week meeting in Chicago. The data were all included in an NDA that Takeda submitted in Japan in February for TAK-438 to treat acid-related diseases. Takeda said it expects a response in Japan by the end of 1Q15, but declined to disclose plans for regulatory submissions in other countries.

Once-daily TAK-438 met the primary endpoint of non-inferiority to once-daily lansoprazole in four of the trials, which were evaluating TAK-438 to treat erosive esophagitis, as maintenance treatment of healed erosive esophagitis and to prevent recurrent gastric or duodenal ulcers. In the fifth trial, twice-daily TAK-438 plus amoxicillin and clarithromycin met the primary endpoint of non-inferiority to twice-daily lansoprazole plus amoxicillin and clarithromycin for Helicobacter pylori infection in patients with scarred gastric or duodenal ulcers. Takeda markets lansoprazole, a benzimidazole proton pump inhibitor (PPI), as Takepron in Japan and as Prevacid in the U.S. ...