Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 03 Nov 2026

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At a glance

09 Sep 2026 According to the Takeda media release, the results from the trial were published in the New England Journal of Medicine.
09 Sep 2026 Results presented in the Takeda media release.
24 Aug 2026 According to the Takeda media release, The Japanese MHLW approval of ORZEYFUL (oveporexton) for adult narcolepsy type 1 was supported by results from the global Phase 3 FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) trials.

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