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Trofinetide - ACADIA Pharmaceuticals/Neuren Pharmaceuticals

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Drug Profile

Trofinetide - ACADIA Pharmaceuticals/Neuren Pharmaceuticals

Alternative Names: DAYBU; DAYBUE; DAYBUE STIX; G-2Me-PE; Glycyl-2-methyl-L-prolyl-L-glutamic acid; Glycyl-L-2-methylprolyl-L-glutamic acid; NNZ-2566

Latest Information Update: 31 Aug 2026

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At a glance

  • Originator Neuren Pharmaceuticals
  • Developer ACADIA Pharmaceuticals; Neuren Pharmaceuticals; Walter Reed Army Institute of Research
  • Class Anti-inflammatories; Glutamates; Neuropeptides; Neuroprotectants; Oligopeptides; Pyrrolidines; Small molecules
  • Mechanism of Action Astrocyte inhibitors; Cytokine inhibitors; Glial cell inhibitors; Insulin-like growth factor I stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Fragile X syndrome; Rett syndrome
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Rett syndrome
  • Phase II Brain injuries; Fragile X syndrome; Traumatic brain injuries
  • Discontinued Autistic disorder; Multiple sclerosis

Most Recent Events

  • 24 Aug 2026 Registered for Rett syndrome (In adults, In children, In adolescents) in European Union, Iceland, Norway, Liechtenstein (PO)
  • 26 Jun 2026 CHMP adopts a positive opinion following a re-examination procedure, on MAA of Trofinetide in Rett syndrome in adults and pediatric patients aged five years and older
  • 02 Mar 2026 Acadia plans to request a re-examination of the negative CHMP opinion on MAA of Trofinetide in Rett syndrome

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