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Daybue FDA Approval History

Last updated by Judith Stewart, BPharm on March 16, 2023.

FDA Approved: Yes (First approved March 10, 2023)
Brand name: Daybue
Generic name: trofinetide
Dosage form: Oral Solution
Company: Acadia Pharmaceuticals, Inc.
Treatment for: Rett Syndrome

Daybue (trofinetide) is a synthetic analog of the amino‐terminal tripeptide of IGF-1 for the treatment of Rett syndrome.

Development timeline for Daybue

DateArticle
May 28, 2024Neuren Phase 2 trial shows significant improvements in Pitt Hopkins syndrome
Mar 13, 2023Approval FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome
Sep 12, 2022Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA
Jul 18, 2022Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome
Dec  6, 2021Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome

Further information

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