Peptide Graded

Trofinetide

Is Trofinetide legal in the US?

Yes, FDA approved for Rett syndrome in people aged 2 and older.

AStrong human evidenceFDA approvedas of 2026-10-26

Trofinetide is approved by the FDA as Daybue (March 2023) for the treatment of Rett syndrome in adults and children 2 years and older, the first drug approved for the condition. The current label on DailyMed (updated September 2026) also covers Daybue Stix, a powder for oral solution. 34

Yes. Daybue was approved in March 2023 for Rett syndrome in patients aged 2 and older. It was the first approved treatment for the disorder. The current label also covers the Daybue Stix powder form. 34

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More on Trofinetide

Citations

  1. Berry-Kravis 2020, Pediatric Neurology: phase 2 trial of trofinetide in adolescent and adult males with fragile X syndrome doi.org
  2. Neul 2023, Nature Medicine: Trofinetide for the treatment of Rett syndrome, phase 3 LAVENDER trial doi.org
  3. FDA 2023: Daybue (trofinetide) approval label accessdata.fda.gov
  4. DailyMed: Daybue (trofinetide) current prescribing information dailymed.nlm.nih.gov
  5. Glaze 2017, Pediatric Neurology: double-blind randomized placebo-controlled phase 2 study of trofinetide in adolescent and adult females with Rett syndrome pubmed.ncbi.nlm.nih.gov
  6. Glaze 2019, Neurology: double-blind randomized placebo-controlled phase 2 study of trofinetide in pediatric Rett syndrome pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Trofinetide article, fact-checked against the cited sources. No dosing anywhere on this site.