Takeda’s Oveporexton Shows Strong Phase III Results for Narcolepsy Type 1

Takeda’s investigational oral therapy, oveporexton (TAK-861), achieved primary and secondary endpoints in two Phase III trials—FirstLight and RadiantLight—for narcolepsy type 1 (NT1). After 12 weeks, patients showed statistically significant and clinically meaningful improvements in wakefulness, cataplexy, excessive daytime sleepiness, attention, and quality of life, with many symptoms nearing normal levels.

The OX2R-selective agonist is designed to compensate for orexin deficiency, a key factor in NT1. The drug was generally well-tolerated, with insomnia and urinary symptoms being the most common side effects. No serious treatment-related adverse events occurred.

Over 95% of trial participants have enrolled in a long-term extension study. Based on these outcomes, Takeda plans to submit a New Drug Application (NDA) to the FDA and international regulators in fiscal year 2025.

This positions oveporexton as a potential first-in-class oral treatment directly targeting the root cause of NT1, with promising implications for long-term symptom control.

14-07-2025