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NCT07593391 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
A Phase 3 study, sponsored by Neuren Pharmaceuticals Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT07593391: Recruiting Phase 3 study, sponsored by Neuren Pharmaceuticals Limited.
NCT07593391 is a Phase 3 study that is actively recruiting participants, run by Neuren Pharmaceuticals Limited. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07593391, a Phase 3 study, is actively recruiting participants, sponsored by Neuren Pharmaceuticals Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of TEAEs, AESI and SAEs across participants
Interventions
- DRUG NNZ-2591
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-05-20 |
| Est. Completion | 2028-11-12 |
| Phase | Phase 3 |
What NCT07593391 shows while recruiting
NCT07593391 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which NNZ-2591 is the first listed.
NCT07593391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07593391 about?
NCT07593391 is a clinical study titled "An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome". 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.
What is the current status of trial NCT07593391?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2026-05-20. Estimated completion is 2028-11-12.
What interventions are being tested in trial NCT07593391?
The interventions under investigation include: NNZ-2591 (DRUG).
Who is sponsoring clinical trial NCT07593391?
This trial is sponsored by Neuren Pharmaceuticals Limited, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07593391's enrollment target sits among peer trials
180 1422nd of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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