Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07051252 | A Study of HBS-201 (Pitolisant Delayed-release) | PHASE1 | COMPLETED | 46 | — | — | May 21, 2025 | Oct 13, 2025 | Dec 12, 2025 | 15 | United States |
A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.
A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| HBS-201 | EXPERIMENTAL | Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14. |
| Name | Type | Description |
|---|---|---|
| HBS-201 | DRUG | On Days 1-7, participants will take HBS-201 17.8 mg per day (one 17.8 mg tablet) and on Days 8-14, participants will take HBS-201 35.6 mg per day (two 17.8 mg tablets). |
Inclusion Criteria: 1\. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. Exclusion Criteria: 1. Has hypersomnolence due to another medical disorder. 2. Is currently taking or has taken ...