Takeda’s First-in-Class Orexin Agonist Oveporexton Posts Stellar Phase III Results

Takeda’s investigational oral orexin receptor 2 agonist, oveporexton (TAK‑861), achieved significant success in two pivotal Phase III trials—FirstLight and RadiantLight—targeting narcolepsy Type 1. Data released on 14 July 2025 showed the drug met all primary and secondary endpoints, delivering notable improvements in wakefulness, daytime sleepiness, cataplexy control, attention, quality of life and overall daily functioning versus placebo. Jefferies analysts highlighted the high statistical significance (p < 0.001), and project peak sales of around $3 billion for this agent alone, with broader orexin-targeted therapies potentially doubling that 

This marks a major turnaround for Takeda’s orexin agonist strategy following the 2021 discontinuation of TAK‑994 due to safety issues. Oveporexton’s Phase IIb outcomes—published in NEJM—demonstrated restoration of clinically meaningful wakefulness and reductions in cataplexy. Takeda plans to submit a new drug application by March 2026 and will present full trial findings at an upcoming scientific meeting