drugset / Trial / NCT07500090

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

NCT07500090 ↗

Phase 3 Recruiting 248 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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Timeline

Start
2026-03-16
Primary completion
2027-10
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject HBS-301 Unknown — Oral