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Takeda Secures Regulatory Approvals for Oveporexton to Treat Narcolepsy Type 1 in Asia and the United States

Takeda has secured regulatory milestones for oveporexton, an oral orexin receptor 2 (OX2R) agonist used to treat narcolepsy type 1. The medication acts on the biological mechanism of the disease by selectively stimulating the OX2R to restore signaling and address the orexin deficiency that causes the chronic neurological disorder. In Japan, the Japanese Ministry of Health, Labour and Welfare approved the drug for adults in August. China's National Medical Products Administration approved the therapy for adults and adolescents aged 16 and older in July. These approvals followed the U.S. Food and Drug Administration approval of the drug for adults in August. Clinical trials involving 273 people with narcolepsy demonstrated that oveporexton significantly improved the ability to stay awake during the day and reduced excessive daytime sleepiness. The treatment also substantially reduced the frequency of cataplexy episodes, which are sudden episodes of muscle weakness. Results showed that between 48% and 69% of treated patients achieved normal wakefulness values, while virtually no participants in the placebo group achieved these results. The most common adverse reactions reported were insomnia, urinary urgency, urinary frequency, and excessive saliva.

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