NewTimeSpace News: On February 10, 2026, Takeda Pharmaceutical issued an announcement disclosing the progress of the New Drug Application for its investigational drug Oveporexton. According to the announcement, the NDA for the drug, indicated for the treatment of Narcolepsy Type 1, has been accepted by the FDA and granted priority review status, marking a key breakthrough in its global launch process.

Oveporexton is an oral selective orexin receptor 2 (OX2R) agonist, whose core mechanism of action is to address the underlying orexin deficiency causing Narcolepsy Type 1 by restoring orexin signaling, tackling the root cause of the disease. It is reported that the drug has previously been granted Breakthrough Therapy Designation by the U.S. FDA and the Center for Drug Evaluation of China's National Medical Products Administration, and also received Sakigake Designation from Japan's Ministry of Health, Labour and Welfare, with its clinical value recognized by regulatory authorities worldwide.

The announcement also specified that the submission of this NDA is supported by a comprehensive clinical data package, including results from the global Phase 3 studies FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002).

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