Fast Track designation for NNZ-2591

Neuren Pharmaceuticals announced in February 2025 that the US Food and Drug Administration (FDA) has granted Fast Track designation for NNZ-2591 for the treatment of Pitt Hopkins syndrome (PTHS). Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions. Currently there are no treatments approved to treat PTHS. In Neuren’s Phase 2 clinical trial of NNZ-2591 in children with PTHS, 82% of participants showed improvement, including communication, social interaction, cognition and motor abilities. We hope to have more information on the next steps soon.

Read more about Neuren Pharmaceuticals here.