Rett Syndrome

• FDA approval · 2026-03-27
  FDA Approved: DAYBUE — Supplemental Application (Acadia Pharmaceuticals Inc.)

  FDA is reviewing a supplemental application for Daybue (trofinetide) from Acadia Pharmaceuticals under NDA 217026, related to Rett syndrome …

• FDA approval · 2025-12-11
  FDA Approved: DAYBUE STIX — Original Application (Acadia Pharmaceuticals Inc.)

  FDA approves DAYBUE STIX (trofinetide) from Acadia Pharmaceuticals as the original NDA (NDA219884) for Rett syndrome.

• FDA approval · 2025-08-05
  FDA Approved: DAYBUE — Supplemental Application (Acadia Pharmaceuticals Inc.)

  FDA approved a supplemental application for Daybue (trofinetide) from Acadia Pharmaceuticals Inc.

• FDA approval · 2024-09-30
  FDA Approved: DAYBUE — Supplemental Application (Acadia Pharmaceuticals Inc.)

  The FDA approved a supplemental application for DayBUE (trofinetide) from Acadia Pharmaceuticals Inc.

• FDA approval · 2023-03-10
  FDA Approved: DAYBUE — Original Application (Acadia Pharmaceuticals Inc.)

  FDA approved DAYBUE (trofinetide) from Acadia Pharmaceuticals as the first approved treatment for Rett syndrome.

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