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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00569972 | A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia | PHASE2 | COMPLETED | 682 | — | — | Oct 1, 2007 | Jan 1, 2009 | Jul 25, 2012 | 84 | United States, Canada |
| NCT00722306 | A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers | PHASE1 | COMPLETED | 6 | — | — | May 1, 2008 | May 1, 2008 | Feb 4, 2011 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 15 mg PD 0200390 | EXPERIMENTAL | - |
| 30 mg PD 0200390 | EXPERIMENTAL | - |
| 45 mg PD 0200390 | EXPERIMENTAL | - |
| 60 mg PD 0200390 | EXPERIMENTAL | - |
| Placebo PD 0200390 | EXPERIMENTAL | - |
| A425 | EXPERIMENTAL | A425 Treated |
| Name | Type | Description |
|---|---|---|
| PD 0200390 | DRUG | Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days |
| Placebo | DRUG | Matched oral placebo for weeks 2-7. |
Inclusion Criteria: * 3 month history of primary insomnia; * 18 to 64 years * For the last 3 months-regularly awake unrefreshed and unrestored * Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Unity Health Toronto | UBX | 1 | PHASE2 | Lemborexant |
| ResMed Inc. | RMD | 1 | NA | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | — | Daridorexant, Non-orexin receptor antagonist medications for insomnia |