UX-DA003 / Shanghai Yuesai Biotech - LARVOL DELTA

Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Shanghai UniXell Biotechnology Co., Ltd

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

UniXell Biotechnology Secures FDA IND Clearance for UX-DA003, Achieving China-U.S. Dual Breakthrough in iPSC Parkinson’s Therapy (The Manila Times) - "UniXell Biotechnology Co., Ltd. ('UniXell') has secured Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson's disease. Paired with the prior IND approval from China's National Medical Products Administration (NMPA) on June 3, 2026, the candidate will undergo clinical development in both China and the United States concurrently, marking a landmark dual-country breakthrough for the company's neurodegenerative disease pipeline."

IND • New trial • Parkinson's Disease