Drug Profile

NouvNeu 001

Alternative Names: Human dopaminergic progenitor cells; NouvNeu-001

Latest Information Update: 25 Sep 2025

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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

Most Recent Events

25 Sep 2025 Phase-II clinical trials in Parkinson's disease (In the elderly, In adults) in China (Parenteral)
15 Aug 2025 NouvNeu 001 receives Fast Track designation for Parkinson disease in USA
03 Aug 2025 iRegene Therapeutics plans a phase I trial for Parkinson's Disease (Treatment-experienced) in USA (Parenteral, Injection) in October 2025 (NCT07102342 )

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