Is Trofinetide approved by the US FDA?

Drugs@FDA lists 3 application product lines for Trofinetide, including DAYBUE (Prescription); DAYBUE STIX (Prescription); DAYBUE STIX (Prescription).

Is Trofinetide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Trofinetide: Daybu.

Are there safety signals or safety updates for Trofinetide?

US FDA: 1 entry (latest 2026-03-27).

Active substance

Trofinetide

US FDA 3
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DAYBUE	200MG/ML	solution · oral	ACADIA PHARMS INC	Prescription	10 Mar 2023
DAYBUE STIX	5000MG/PACKET; 6000MG/PACKET; 8000MG/PACKET	for solution · oral	ACADIA PHARMS INC	Prescription	11 Dec 2025
DAYBUE STIX	10,000MG; 12,000MG	solution · oral	ACADIA PHARMS INC	Prescription	11 Dec 2025

EMA European Union — centrally authorised medicines

Daybu Acadia Pharmaceuticals B.V. · Authorised · authorised 20 Aug 2026 · ATC N07XX24

Therapeutic indication (EMA)

Daybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DAYBUE	02552523	200 MG / ML	SOLUTION · ORAL; GASTRIC	ACADIA PHARMACEUTICALS INC.

Safety signals and safety-related labeling changes

US FDA 27 Mar 2026 DAYBUE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for trofinetide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.