Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Org 50081 · 2 trials · 3 indications
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.
| Arm | Type | Description |
|---|---|---|
| Esmirtazapine | EXPERIMENTAL | One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks |
| Treatment 1 | EXPERIMENTAL | - |
| Treatment 2 | EXPERIMENTAL | - |
| Treatment 3 | PLACEBO_COMPARATOR | - |
| Treatment 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Org 50081 | DRUG | One tablet daily |
| Placebo | DRUG | Once daily on Day 1-7 |
| zopiclone | DRUG | Single dose of 7.5 mg |
Inclusion Criteria: * sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations; * completed Protocol P05706 or P05707; * Have safety and efficacy assessments conducted per protocol P05706 or P05707. Exclusion Cr...
| 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 |
Org 50081 is an investigational small molecule being developed for sleep initiation and maintenance disorders, specifically insomnia. It is in Phase 3 clinical development for this psychiatric condition. The drug is not approved and remains under study.
Org 50081 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug for insomnia and sleep initiation and maintenance disorders.
Org 50081 is in Phase 3 clinical development for insomnia. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 extension trial has been completed, along with a Phase 1 study.
Org 50081 has been studied in two completed trials. NCT00610675 was a 52-week Phase 3 extension trial in 346 patients with insomnia. NCT00798395 was a Phase 1 study in 32 healthy volunteers assessing driving ability and psychomotor performance.
Yes, Org 50081 is also known as esmirtazapine. The Phase 3 trial title refers to Org 50081 (Esmirtazapine) in the treatment of insomnia, confirming that these names refer to the same drug.