Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4305 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MK-4305 40 mg | EXPERIMENTAL | Day 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 |
| MK-4305 20 mg | EXPERIMENTAL | Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo |
| Zopiclone 7.5 mg | ACTIVE_COMPARATOR | Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo |
| Placebo | PLACEBO_COMPARATOR | Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo |
| Name | Type | Description |
|---|---|---|
| MK-4305 40 mg | DRUG | 4 x 10 mg MK-4305 tablets |
| MK-4305 20 mg | DRUG | 2 x 10 mg MK-4305 tablets |
| Zopiclone | DRUG | 1 x 7.5 mg Zopiclone tablet |
| Grossly Matching Placebo for Zopiclone | DRUG | Grossly Matching Placebo for Zopiclone |
| Matching Placebo for MK-4305 | DRUG | Matching Placebo for MK-4305 |
Inclusion Criteria: * Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study * Has a body mass index (BMI) within ...
| 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 |
| ResMed Inc. | RMD | 1 | N/A | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | - | Daridorexant, Non-orexin receptor antagonist medications for insomnia |
MK-4305 is an investigational small molecule being developed for the treatment of insomnia. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its effects on sleep and next-day performance in patients with insomnia.
MK-4305 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is in Phase 1 clinical development for the treatment of insomnia.
MK-4305 is in Phase 1 clinical development. It is an investigational drug for insomnia and has not been approved by the FDA or other regulatory agencies. The drug is still in early-stage clinical testing to evaluate its safety and effects.
MK-4305 has one completed Phase 1 clinical trial, identified as NCT01311882. This study, titled "A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)", enrolled 28 participants in the Netherlands. The trial was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 21 years and older.
MK-4305 is the development code for suvorexant, a drug being studied for insomnia. It is an investigational small molecule developed by Merck & Company, Inc. The drug is in Phase 1 clinical development and has not been approved for use.