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Japan’s Zeria To Start Phase III Trial For Functional Dyspepsia Therapy In Europe

This article was originally published in PharmAsia News

Executive Summary

Tokyo-based Zeria Pharmaceutical announced European Phase II double-blind trial results for Z-338 (acotimiade), a functional dyspepsia therapy developed by the company. The trial was conducted in 76 facilities and enrolled 473 patients from eight countries. According to the company, the result showed acotimiade effective compared to placebo and there was no safety issue. Zeria has decided to start consultation with European Medicines Agency on a Phase III trial, and the company also is considering partnering with other companies to speed up the development process. Japanese major drug maker Astellas has licensed the drug's exclusive rights in the U.S., and the two companies are jointly conducting a Phase II trial. In Japan, Zeria and Astellas collaborate on an ongoing Phase III trial. In Japan, one in every four adults is found to have FD symptoms. (Click here for more - Japanese language
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