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NCT05879614: PWS-001
An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)
Phase 2 trial testing NNZ-2591 in Prader-Willi Syndrome. Withdrawn.
30 June 2025
Quick facts
| Lead sponsor | Neuren Pharmaceuticals Limited |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 September 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- NNZ-2591 — full drug profile →
Conditions studied
- Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →
Sponsor
Neuren Pharmaceuticals Limited — full company profile →
Who can join
Adults 4 to 12, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Prader-Willi Syndrome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05879614
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NNZ-2591
Trials testing the same drug.
- NCT07281079 — A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome · Phase 3 · recruiting
- NCT05025332 — An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001) · Phase 2 · completed
- NCT05025241 — An Open-Label Study of Oral NNZ-2591 in Phelan-McDermid Syndrome (PMS-001) · Phase 2 · completed
- NCT05011851 — An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome · Phase 2 · completed
- NCT04379869 — To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers · Phase 1 · completed
Other recruiting trials for Prader-Willi Syndrome
Currently open trials in the same condition.
- NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
- NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
- NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting
Other Neuren Pharmaceuticals Limited trials
Trials by the same sponsor.
- NCT07281079 — A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome · Phase 3 · recruiting
- NCT05025332 — An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001) · Phase 2 · completed
- NCT05025241 — An Open-Label Study of Oral NNZ-2591 in Phelan-McDermid Syndrome (PMS-001) · Phase 2 · completed
- NCT05011851 — An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome · Phase 2 · completed
- NCT04379869 — To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05879614 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neuren Pharmaceuticals Limited
- Last refreshed: 9 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05879614.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing