On April 1, 2020 Oncoceutics, Inc., reported that it was informed by its Japanese licensee, Ohara Pharmaceutical Co., Ltd., of the initiation of a Phase I/II clinical study of OP-10 (the Japanese name for ONC201) in Japan and the administration of the drug to the first patient (Press release, Oncoceutics, APR 1, 2020, View Source [SID1234558313]).

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ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patients with high-grade glioma. In February 2019, Oncoceutics outlicensed rights to ONC201 for Japan to Ohara. Under this strategic partnership, Ohara is responsible for conducting clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.

"We are excited to continue to work with the dedicated team of experts at Ohara as we expand the development of ONC201 to important markets outside the U.S.," said Lee Schalop, MD, Chief Operating Officer of Oncoceutics. "This clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201, and data from this study will be an important part of working toward a Japanese market approval for ONC201."