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Also known as HBS-301 tablet, pitolisant delayed-release
HBS-301 · 2 trials · 5 indications
The ESS is an 8-item, 4-point rating scale.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Treatment Period HBS-301 | EXPERIMENTAL | HBS-301 tablets administered once daily in the morning upon wakening |
| Double-blind Treatment Period Placebo | PLACEBO_COMPARATOR | Matching placebo tablets administered once daily in the morning upon wakening |
| Open-Label Extension Period HBS-301 | EXPERIMENTAL | HBS-301 tablets administered once daily in the morning upon wakening |
| Name | Type | Description |
|---|---|---|
| HBS-301 | DRUG | HBS-301 tablet |
| Placebo | OTHER | Placebo tablet |
| HBS-301 tablet | DRUG | HBS-301 tablet |
Inclusion Criteria: * Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years. * Has EDS. * If taking a permitted chronic concomitant medication or supplement, i...
HBS-301 is an investigational small molecule being developed by Harmony Biosciences Holdings, Inc. (ticker HRMY) for neurological sleep disorders. It is in Phase 3 clinical development for excessive daytime sleepiness (EDS) and idiopathic hypersomnia. HBS-301 is also known as HBS-301 tablet.
HBS-301 is being studied for excessive daytime sleepiness (EDS) and idiopathic hypersomnia. Phase 3 trials are also evaluating it in narcolepsy, including symptoms such as cataplexy and fatigue. It is investigational and has not been approved for any use.
HBS-301 targets H3R, the histamine H3 receptor. It is a small molecule designed to act on this receptor, a mechanism relevant to promoting wakefulness in sleep disorders such as excessive daytime sleepiness and idiopathic hypersomnia.
HBS-301 is being developed by Harmony Biosciences Holdings, Inc., which trades under the ticker HRMY. The company is running Phase 3 clinical trials of HBS-301 in the United States and Canada for sleep-related neurological conditions.
HBS-301 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Two Phase 3 trials are currently recruiting: one in narcolepsy and one in idiopathic hypersomnia.
HBS-301 is being studied in two recruiting Phase 3 trials. NCT07675135 is a Phase 3 efficacy and safety study in participants with narcolepsy, enrolling 258 adults in the United States and Canada. NCT07500090 is a Phase 3 efficacy and safety study in participants with idiopathic hypersomnia, enrolling 248 adults.
Yes, HBS-301 tablet is another name for HBS-301. Both refer to the same investigational small molecule developed by Harmony Biosciences Holdings, Inc. (HRMY) for excessive daytime sleepiness and idiopathic hypersomnia.