Two phase 3 trials published this week in The New England Journal of Medicine confirm that oveporexton, an oral drug developed by Takeda, significantly reduces

Dos ensayos de fase 3 publicados esta semana en The New England Journal of Medicine confirman que oveporexton, un fármaco oral desarrollado por Takeda, reduce d

Takeda has reported pivotal results from its Phase III FirstLight and RadiantLight studies of oveporexton, an oral OX2R-selective agonist, for the treatment of NT1.

Reported Monday, Sep 8 - 5:17am EDT (TheFly subscription required to read more.)

Takeda (NYSE:TAK) presented groundbreaking Phase 3 clinical trial results for oveporexton (TAK-861), their first-in-class oral orexin receptor agonist for narcolepsy type 1 (NT1), at World Sleep 2025. The FirstLight and RadiantLight studies met all primary and secondary endpoints with statistically significant improvements (pKey findings showed that oveporexton significantly improved wakefulness, with 85% of participants achieving normal sleepiness scores and over 80% reduction in cataplexy rates. The drug was generally well-tolerated with no serious treatment-related adverse events. The comprehensive program involved 273 patients across 19 countries, with over 95% of participants continuing into the long-term extension study.Takeda plans to submit global regulatory applications starting in fiscal year 2025, potentially transforming NT1 treatment by addressing its underlying cause.

Takeda (NYSE:TAK) announced breakthrough results from two Phase 3 studies of oveporexton (TAK-861) for narcolepsy type 1 (NT1) treatment. The FirstLight and RadiantLight trials demonstrated statistically significant improvements across all primary and secondary endpoints with p-values <0.001 at all doses.The studies showed clinically meaningful improvements in wakefulness, excessive daytime sleepiness, cataplexy, attention, and quality of life, with most participants reaching near-normal ranges. Oveporexton was generally well-tolerated, with no serious treatment-related adverse events reported. Common side effects included insomnia and urinary issues.Takeda plans to submit regulatory applications globally in fiscal year 2025, aiming to bring this first-in-class oral orexin receptor 2 agonist to market as quickly as possible.