Insilico Medicine Cayman Topco announced FDA clearance of an investigational new drug (IND) application for ISM‑8969, enabling initiation of a Phase I trial in healthy volunteers for a Parkinson’s disease candidate. The clearance permits the company to assess safety, tolerability and early pharmacokinetics as the first clinical milestone. Insilico, known for AI‑driven drug discovery, positioned the IND as validation of its computational pipeline translating into a clinical candidate. The Phase I study will generate human data that could inform dose selection and progression to patient studies. If ISM‑8969 clears safety and PK thresholds, Insilico will aim to move into disease cohorts. The IND also signals continued regulatory openness to AI‑enabled discovery programs transitioning into human testing.