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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Trofinetide (Primary)
  • Indications Rett syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms LAVENDER
  • Sponsors Acadia Pharmaceuticals

Most Recent Events

  • 05 Mar 2025 According to an Acadia Pharmaceuticals media release, results of DAFFODIL, LAVENDER, LILAC-1 and LILAC-2 studies supported the FDA approval of DAYBUE in adults and pediatric patients two years of age or older.
  • 14 Jan 2025 According to an Acadia Pharmaceuticals media release, company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older, with expected approval in the first quarter of 2026.
  • 16 Oct 2024 According to a Neuren Pharmaceuticals media release, Health Canada has granted marketing authorization of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process. The Health Canada filing was supported by positive results from the pivotal Phase 3 LAVENDER.

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