An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

Phase 3 Recruiting 180 enrolled Neuren Pharmaceuticals Limited

NaSingle-groupOpen-labelTreatment

Summary

This Phase 3, open-label extension, multicenter study will evaluate long-term safety, tolerability and efficacy of NNZ-2591 in pediatric participants with Phelan- McDermid Syndrome.

Timeline

Start: 2026-06-08
Primary completion: 2028-10-29
Completion: 2028-11-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NNZ-2591	Small molecule	—	Oral

An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

Summary

Timeline

Drugs

Indications