Oveporexton (TAK-861-2001)

June 15, 2026: Takeda (TAK) presented secondary and exploratory endpoint results at SLEEP 2026 (June 14–17, 2026) from two global Phase 3, placebo-controlled narcolepsy type 1 (NT1) studies of oveporexton (TAK-861), an oral orexin receptor 2–selective agonist: FirstLight (TAK-861-3001; NCT06470828; BID 2 mg, 1 mg, placebo; n=168) and RadiantLight (TAK-861-3002; NCT06505031; BID 2 mg, placebo; n=105). At week 12, oveporexton significantly improved daily functioning versus placebo across all six Functional Impacts of Narcolepsy Instrument (FINI) domains at all doses (p<0.001). Cognitive symptoms improved versus placebo on objective neuropsychological tests and patient-reported measures; ~70% of patients across doses reported no significant cognitive difficulties on the FINI Cognitive Function domain vs ~15% on placebo. Exploratory sleep endpoints showed improved sleep quality, with most patients reporting no hallucinations or sleep paralysis and meaningful reductions in disturbed nighttime sleep on the 2/2 mg dose; REM sleep timing/pattern shifted toward healthy controls. Takeda said the FDA accepted the NDA and granted Priority Review; PDUFA goal date is in Q3 of this calendar year. Submissions are also under review in China and Japan, with additional submissions planned throughout the year.