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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)

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: 05 Nov 2025

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At a glance

  • Drugs Oveporexton (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms FirstLight
  • Sponsors Takeda

Most Recent Events

  • 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).
  • 08 Sep 2025 According to the Takeda media release, the company will present data from FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies, during multiple oral presentations at the World Sleep 2025 Congress in Singapore beginning at 3:15 p.m. SGT on 8 Sep 2025. Emmanuel Mignot, M.D., Ph.D., principal investigator for this study is one of the presenting authors.
  • 08 Sep 2025 According to the Takeda media release, Emmanuel Mignot, M.D., Ph.D. is the principal investigator for the FirstLight Phase 3 study.

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