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Phase 3 randomized double-blind placebo-controlled study of HBS-301 in adults with narcolepsy with open-label extension
2025-523821-17-00Phase 3Authorised
- Sponsor
- Harmony Biosciences
- Start
- Sep 2026
- Modality
- Small Molecules
- Countries
- 8
01
Overview
Phase 3, randomised, double-blind trial in narcolepsy comparing HBS-301 with Placebo (2 arms). Primary endpoint: Change in severity of excessive daytime sleepiness measured by the Epworth Sleepiness Scale. Planned start Sep 2026; status: authorised.
02
Drugs
pitolisant
03
Conditions
narcolepsy
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