DR.NOAH BIOTECH

DR.NOAH BIOTECH has developed a robust pipeline of AI-discovered combination therapies targeting neurological and muscular rare/orphan diseases. Their lead program NDC‑011 received FDA IND approval in August/September 2024 to begin a U.S. Phase I trial in ALS after showing strong preclinical efficacy; it also holds Orphan Drug Designation from the FDA. NDC‑002 completed Korea’s first-ever Phase I trial of an AI-developed stroke recovery therapy in 2023 with promising results on motor function restoration. NDC‑026 for Duchenne Muscular Dystrophy has both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA based on positive preclinical outcomes.