Trofinetide
Also known as: Daybue, Glypromate, GPE analog, GPE analogue, NNZ-2566
Source Trofinetide at Peptiology
Save 10% with code PEPTI-BOSSRABBIT-10
Tapping Shop Now & Save 10% copies your 10% off code PEPTI-BOSSRABBIT-10 to your clipboard. Paste it at the Peptiology checkout to claim the discount.
Summary
Trofinetide is an oral synthetic peptide analog of glycine‑proline‑glutamate approved for the treatment of Rett syndrome in patients aged ≥5 years, improving neurobehavioral function.
Mechanism of Action
Modulates neuroinflammation and synaptic function; enhances microtubule stability and neuronal connectivity
Routes of Administration
Goals & Uses
- Fragile X syndromeNeurological DisorderLow
- Improvement of synaptic functionNeuroscienceModerate
- Rett syndromeNeurodevelopmental DisorderHigh
- Treatment of Rett syndromeNeurodevelopmental DisorderHigh
- Traumatic brain injuryNeuroprotectionLow
- Reduction of neuroinflammationNeurologyModerate
Contraindications
- Hypersensitivity to trofinetide or excipientsAllergic/immunologicHigh
- Hypersensitivity to trofinetideAllergyHigh
- Severe renal impairmentOrganModerateKidney function concerns
Adverse Effects
- NasopharyngitisInfectiousCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Weight loss / decreased appetiteMetabolicCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- FatigueGeneralUncommonLow energy or tiredness
- VomitingGastrointestinalCommonForceful expulsion of stomach contents
- DiarrheaGastrointestinalCommonLoose or frequent stools
- DehydrationFluid BalanceUncommonLoss of body water or inadequate hydration
- Abdominal painGastrointestinalCommonPain or discomfort in the abdomen
Drug Interactions
- Oral contraceptivesModerateDelayed gastric emptying may affect absorption timing
- none identifiedLow
- CYP3A4 substrates (sensitive)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Age ≥5 yearsAgeAbsolute
- Children under 2 years of agePediatricAbsolute
- BreastfeedingReproductiveRelative
- Severe renal impairment (eGFR <30 mL/min)RenalRelative
Regulatory Status
- European UnionInvestigationalSubmitted for marketing authorization; pending
- United StatesApprovedApproved: Rett syndromeApproved as Daybue for patients ≥5 years
- United KingdomUnknown
FDA approved in August 2023 (brand name Daybue) as the first therapy for Rett syndrome; under regulatory review in the EU.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Trofinetide?
Trofinetide is an oral synthetic peptide analog of glycine‑proline‑glutamate approved for the treatment of Rett syndrome in patients aged ≥5 years, improving neurobehavioral function.
What is Trofinetide used for?
Trofinetide is educationally associated with: Fragile X syndrome, Improvement of synaptic function, Rett syndrome, Treatment of Rett syndrome, Traumatic brain injury, Reduction of neuroinflammation. Educational only — not medical advice.
How is Trofinetide administered?
Recorded routes of administration: Oral.
What are the potential side effects of Trofinetide?
Reported adverse effects include: Nasopharyngitis, Headache, Weight loss / decreased appetite, Nausea, Fatigue, Vomiting, Diarrhea, Dehydration, Abdominal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Trofinetide?
Recorded contraindications: Hypersensitivity to trofinetide or excipients, Hypersensitivity to trofinetide, Severe renal impairment. Consult a qualified clinician before use.