Drug Profile

NouvNeu 001

Alternative Names: Human dopaminergic progenitor cells; NouvNeu-001

Latest Information Update: 29 Apr 2026

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At a glance

Originator iRegene Therapeutics
Class Antiparkinsonians; Induced pluripotent stem cell therapies
Mechanism of Action Cell replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Phase II Parkinson's disease
Phase I Multiple system atrophy

Most Recent Events

24 Apr 2026 iRegene Therapeutics plans a phase I trial for Parkinson's Disease in China (Intrastriatal, Injection) in May 2026 (NCT07550374)
23 Feb 2026 Phase-II clinical trials in Parkinson's disease in USA (Parenteral)
20 Jan 2026 NouvNeu 001 receives Regenerative Medicine Advanced Therapy (RMAT) status for Parkinson's disease in USA

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