drugset / Trial / NCT07675135

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

NCT07675135 ↗

Phase 3 Recruiting 258 enrolled Harmony Biosciences Management, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-06-04
Primary completion
2027-10
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject HBS-301 Unknown — —