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: 18 Apr 2026

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At a glance

11 Feb 2026 According to the Takeda media release, U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). with Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year.
29 Jan 2026 According to the Takeda media release, the company has submitted New Drug Applications (NDA) for oveporexton.
08 Sep 2025 According to the Takeda media release, the company will host an investor call to discuss the Phase 3 data and market opportunity for oveporexton on September 8, at 7:30-8:45 p.m. SGT/7:30-8:45 a.m. EDT (8:30-9:45 p.m. JST).

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