Sponsor Name: Harmony Biosciences Management, Inc.
Regulatory Agency Identifier Numbers: IND 179310; EU Trial Number 2025-523821-17-00
Protocol Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.