May 12 2026
ONSTRIDE-1: 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

NOW RECRUITING adults (ages ≥18 years) with a documented diagnosis of narcolepsy. The purpose of this clinical trial is to evaluate the safety and efficacy of HBS-301 (pitolisant delayed-release tablets) in treating narcolepsy symptoms, which include excessive daytime sleepiness, cataplexy, and fatigue in adults diagnosed with narcolepsy (type 1 or type 2). HBS-301 is a new delayed-release pitolisant tablet formulation with a coating that was developed to facilitate how pitolisant gets absorbed into the body. This study will also evaluate a higher dose of pitolisant than what is currently approved for people with narcolepsy.

Participation in the ONSTRIDE-1 study is expected to last approximately 16 weeks, followed by an optional open-label extension period (1 year). For further information about this clinical study, please see details on the ONSTRIDE-1 website by clicking here. You will be able to review the study information, study visit schedule, key participation criteria, and current study locations.

If you have further interest in this study as a potential participant, please contact Harmony Biosciences at clinicaltrials@harmonybiosciences.com.