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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07096674 | A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia | PHASE2 | RECRUITING | 90 | — | — | Aug 12, 2025 | Apr 30, 2026 | Apr 16, 2026 | 24 | United States, Canada +2 |
| NCT06752668 | A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia | PHASE2 | RECRUITING | 248 | — | — | Dec 23, 2024 | Dec 1, 2026 | Apr 27, 2026 | 37 | United States, Canada +3 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Number of Participants With Abnormal Change From Baseline in Vital Signs
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
| Arm | Type | Description |
|---|---|---|
| Narcolepsy Type 1 | EXPERIMENTAL | Narcolepsy Type 1 (Open Label) |
| Narcolepsy Type 2 | EXPERIMENTAL | Narcolepsy Type 2 (Open Label) |
| Idiopathic Hypersomnia | EXPERIMENTAL | Idiopathic Hypersomnia (Open Label) |
| Narcolepsy Type 1: ORX750 and Placebo | EXPERIMENTAL | - |
| Narcolepsy Type 2: ORX750 and Placebo | EXPERIMENTAL | - |
| Idiopathic Hypersomnia: ORX750 and Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ORX750 | DRUG | Oral ORX750 |
| Placebo | DRUG | ORX750 matching placebo capsule. |
Inclusion Criteria: * Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1) * Is willing and able to adhere to additional protocol requirements Exclusion Criteria: * Development of any new disea...