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NOUVNEU001 is an induced pluripotent stem cell (iPSC)-derived, chemically induced human dopaminergic neuron precursor therapy developed by iRegene Therapeutics. It is designed as a cell replacement therapy for neurodegenerative disorders, primarily Parkinson's disease (PD) and Multiple System Atrophy (MSA). The therapy involves the stereotactic transplantation of dopaminergic progenitor cells into the bilateral putamen, where they are expected to survive, mature into functional dopaminergic neurons, and reconstitute neural circuits to restore dopamine levels. Clinical data from Phase 1 studies have demonstrated safety, tolerability, and preliminary efficacy, including improvements in motor function (UPDRS Part III scores) and restoration of dopaminergic function as evidenced by PET imaging.
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