Peptide Graded

Trofinetide (predecessor programs)

Is Trofinetide (predecessor programs) safe?

Short trials; diarrhea common in Rett phase 3

BSome human evidenceFDA approvedas of 2026-10-26

Across the development program the main side effects were in the gut. In LAVENDER, diarrhea affected 81 percent of trofinetide patients and vomiting 27 percent. These are the main warnings in the approved label, along with weight loss. In the 28-day fragile X trial both doses were well tolerated. 124

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Citations

  1. Berry-Kravis 2020, Pediatric Neurology: randomized placebo-controlled phase 2 trial of trofinetide in 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. Wei 2009, J Neuroinflammation: NNZ-2566 inhibits neuroinflammation after penetrating ballistic-like brain injury in rats pubmed.ncbi.nlm.nih.gov

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