Summary: Takeda’s investigational orexin-2 receptor agonist oveporexton met all primary and secondary endpoints in two phase 3 trials for narcolepsy type 1, showing significant symptom improvements and supporting plans for global regulatory submissions in 2025. Key takeaways:Takeda’s narcolepsy type 1 drug candidate met all endpoints in both phase 3 studies, demonstrating statistically significant improvements across symptoms at all doses. All primary and secondary endpoints were met in two phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), Takeda’s potential first-in-class investigational oral orexin receptor 2-selective agonist, in narcolepsy type 1 (NT1). For the first time, a drug candidate that addresses the underlying orexin deficiency in narcolepsy type 1 human trials has been validated in phase 3 studies, which demonstrate significant improvement across a broad range of symptoms. Safety ProfileOveporexton was generally well-tolerated with a safety profile from the phase 3 studies overall consistent with oveporexton studies to date, including the phase 2b study.