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Neuren Pharmaceuticals Limited (AU:NEU)
ASX:NEU
Nnz-2591
Phelan-Mcdermid Syndrome
Phase III
Recruiting
A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
Nov 13, 2025
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Nnz-2591
Prader-Willi Syndrome
Phase II
Withdrawn
An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)
May 18, 2023
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Nnz-2591
Pitt Hopkins Syndrome
Phase II
Completed
An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)
Aug 24, 2021
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Nnz-2591
Phelan-Mcdermid Syndrome
Phase II
Completed
An Open-Label Study of Oral NNZ-2591 in Phelan-McDermid Syndrome (PMS-001)
Aug 24, 2021
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Nnz-2591
Angelman Syndrome
Phase II
Completed
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome
Aug 05, 2021
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Nnz-2591
Healthy Volunteers
Phase I
Completed
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Apr 30, 2020
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Nnz-2566
Rett Syndrome
Phase II
Completed
A Safety Study of NNZ-2566 in Pediatric Rett Syndrome
Feb 21, 2016
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Nnz-2566
Concussion
Phase II
Terminated
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
Mar 19, 2014
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Nnz-2566
Fragile X Syndrome
Phase II
Completed
A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome
Jul 03, 2013
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Nnz-2566
Rett Syndrome
Phase II
Completed
A Safety Study of NNZ-2566 in Patients With Rett Syndrome
Oct 04, 2012
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Neuren Pharmaceuticals Limited (NEU) have in its pipeline
NEU is currently developing the following drugs: Nnz-2591, Nnz-2591, Nnz-2591. These drug candidates are in various stages of clinical development as the company works toward FDA approval.