UniXell secures US FDA clearance for Parkinson's disease cell therapy
UniXell Biotechnology has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson's disease.
The approval follows the candidate's earlier IND clearance from China's National Medical Products Administration (NMPA), enabling parallel clinical development in both the US and China.
The milestone strengthens UniXell's strategy of advancing both personalised autologous and off-the-shelf allogeneic iPSC therapies for neurodegenerative diseases.
UX-DA003 is an allogeneic iPSC-derived midbrain dopaminergic progenitor cell therapy developed using UniXell's proprietary cell lineage tracing and directed differentiation technologies.
Preclinical studies showed high functional dopaminergic neuron purity, lower dosing requirements and a favourable long-term safety profile, supporting its potential for large-scale clinical use.
The FDA clearance represents UniXell's fourth regulatory milestone across China and the US within the past three months.
Alongside UX-DA003, the company is advancing UX-DA001, an autologous iPSC therapy currently in a Phase I clinical trial for Parkinson's disease, with early safety findings reported as encouraging.
UniXell said the regulatory submissions for UX-DA003 are supported by a unified iPSC seed cell platform and standardised manufacturing process, providing a foundation for global clinical development and future commercialisation.
