Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HBS-301 tablet
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 for excessive daytime sleepiness (EDS) and idiopathic hypersomnia. It is also being studied in narcolepsy, including symptoms of cataplexy and fatigue. The drug is in Phase 3 clinical development and is not yet approved by the FDA.
HBS-301 is a small molecule in development for neurological sleep disorders. Its specific molecular target has not been disclosed in available information. The drug is being evaluated for its effects on excessive daytime sleepiness and idiopathic hypersomnia in clinical trials.
HBS-301 is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on NASDAQ under the ticker HRMY. The company is conducting Phase 3 clinical trials for the drug in the United States and Canada.
HBS-301 is currently in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 3 trials are actively recruiting participants to evaluate its efficacy and safety in idiopathic hypersomnia and narcolepsy.
HBS-301 is being studied in two Phase 3 trials. NCT07500090 is evaluating the drug in 248 participants with idiopathic hypersomnia in the United States. NCT07675135 is studying 258 participants with narcolepsy in the United States and Canada. Both trials are randomized, double-blind, and placebo-controlled.
Yes, HBS-301 is also known as HBS-301 tablet. The drug is an oral small molecule being developed by Harmony Biosciences for the treatment of excessive daytime sleepiness and idiopathic hypersomnia. It is currently in Phase 3 clinical trials.