On 10 March 2023 Neuren’s North America partner Acadia Pharmaceuticals received marketing approval from the U.S. Food and Drug Administration (FDA) for DAYBUE™ (trofinetide) to treat Rett syndrome in adults and pediatric patients 2 years of age and older. Please refer to the ACADIA Pharmaceuticals website for further information about DAYBUE™ (trofinetide) in the United States.
Click here for Acadia's product information
Outside North America Neuren intends to pursue registration and commercialisation of trofinetide for Rett syndrome through partners and is currently discussing that with a number of third parties. Currently, Neuren does not have the necessary approvals or available drug supply to enable any compassionate use or named patient programs.