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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: 10 Mar 2026

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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

  • 02 Mar 2026 According to an ACADIA Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) informed the company it has formally adopted a negative opinion regarding the Marketing Authorization Application for trofinetide for the treatment of Rett syndrome in patients two years of age and older. Acadia has reviewed the CHMP grounds for refusal in detail and intends to request a re-examination of the opinion.
  • 02 Feb 2026 According to Acadia Pharmaceuticals media release, the Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on its Marketing Authorization Application (MAA) for trofinetide for the treatment of Rett syndrome, following its recent CHMP oral explanation. Subject to the outcome of the CHMP vote in February, Acadia intends to request a re-examination of the opinion by the CHMP upon its formal adoption.
  • 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.

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