Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rozerem · 1 trial · 2 indications
Time to sleep onset as determined by polysomnography
| Arm | Type | Description |
|---|---|---|
| Ramelteon | EXPERIMENTAL | Ramelteon 8 mg oral before bedtime |
| sugar pill | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| rozerem | DRUG | Ramelteon (rozerem) 8mg oral before bedtime |
| Placebo | DRUG | placebo |
Inclusion Criteria: * Obstructive sleep apnea * Insomnia * Age\>60 Exclusion Criteria: * Cognitive impairment * Active alcohol or substance abuse * Active use of other sedative-hypnotic agents * Active use of fluvoxamine (drug interaction with Ramelteon * Evidence of hepatic dysfunction (Ramelteo...
| 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 |
Rozerem is used for the treatment of insomnia. It is a small molecule being developed by Takeda Pharmaceutical Company Limited. In clinical trials, it has been studied for insomnia in elderly patients with obstructive sleep apnea. The drug is currently in Phase 3 clinical development.
Rozerem targets the melatonin receptors in the brain. It works by binding to these receptors to help regulate the sleep-wake cycle, which can improve sleep onset in patients with insomnia. This mechanism is particularly relevant for elderly patients who may have disrupted circadian rhythms.
Rozerem is developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is publicly traded under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of Rozerem for the treatment of insomnia.
Rozerem is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, which studied the drug in elderly patients with insomnia and obstructive sleep apnea.
Rozerem has been studied in one completed Phase 3 clinical trial with the identifier NCT01048242. This trial, titled 'Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)', enrolled 27 participants in the United States. The study was randomized, double-blind, and placebo-controlled.
Yes, Rozerem is the brand name for ramelteon, which is also known as TAK 375. The clinical trial NCT01048242 refers to the drug as ramelteon (TAK 375). This medication is being developed by Takeda Pharmaceutical Company Limited for the treatment of insomnia.