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Library · Brain & nerves · Rett syndrome treatment

Trofinetide

Daybue

FDA-approved in 2023 as the first drug for Rett syndrome in patients two and older, this synthetic analogue of the IGF-1-derived tripeptide GPE showed statistically significant benefit on co-primary endpoints in the Phase 3 LAVENDER trial, through an unclear mechanism thought to involve neuroprotection.

Research score 88/100. Reference only, not a dose.

  • Neuroprotection
  • Anti-inflammatory
US status
Prescription Only
Approval
FDA Approved (2023)
Evidence
LAVENDER Phase 3: statistically significant improvement on both co-primary endpoints vs placebo
Research score
88 / 100
Indication
Rett syndrome
Origin
United States
Source category
Brain & Nervous System
Status group
Approved / prescription

Mechanism

Believed to reduce inflammation, glutamate-driven excitotoxicity, oxidative stress, and cell death, though the precise mechanism is unknown.

Safety file

Most common adverse effects are diarrhea, about 82%, and vomiting, about 29%.

  • Diarrhea (82%)
  • Vomiting (29%)
  • Fever
  • Seizure
  • Anxiety
  • Decreased appetite
  • Fatigue