US FDA approves Daybue STIX (trofinetide) for oral solution, a new powder formulation, for Rett syndrome

Neuren Pharmaceuticals

15 December 2025 - Neuren Pharmaceuticals today announced that its partner Acadia Pharmaceuticals has received US FDA approval of Daybue STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and paediatric patients two years of age and older. 

The new powder formulation offers children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their Daybue treatment.

Read Neuren Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration