Approval Probability
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ML Risk
volinanserin · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Volinanserin | EXPERIMENTAL | Volinanserin 2 mg for a maximum of 87 days |
| Placebo | PLACEBO_COMPARATOR | Placebo for volinanserin for a maximum of 106 days |
| Name | Type | Description |
|---|---|---|
| volinanserin (M100907) | DRUG | oral, one tablet taken around bedtime |
| Placebo | DRUG | oral, one tablet taken around bedtime |
| volinanserin | DRUG | oral administration |
Inclusion Criteria: * Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria * Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month Sub-study : * Patients will ...
Volinanserin is an investigational small molecule being developed by Sanofi for sleep initiation and maintenance disorders, a condition commonly known as insomnia. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
Volinanserin targets the serotonin 5-HT2A receptor, a subtype of serotonin receptor involved in the regulation of sleep and wakefulness. By modulating this receptor, the drug is designed to improve sleep maintenance and initiation in patients with insomnia. This mechanism is the basis for its investigational use in sleep disorders.
Volinanserin is being developed by Sanofi, a global biopharmaceutical company headquartered in France. Sanofi's stock is traded on the NASDAQ under the ticker symbol SNY. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy for sleep initiation and maintenance disorders.
Volinanserin is currently in Phase 3 clinical development. It has completed two Phase 3 trials, both of which were randomized, double-blind, and placebo-controlled. However, the drug is still investigational and has not received FDA approval. Its safety and efficacy profile is still being evaluated through clinical studies.
Volinanserin has completed two Phase 3 clinical trials. The first, NCT00464243, enrolled 604 participants and studied the drug's efficacy and safety on sleep maintenance insomnia using polysomnography. The second, NCT00495885, enrolled 848 participants and included a sub-study in patients with stable type II diabetes mellitus. Both trials were conducted across multiple countries.
Yes, volinanserin is also known as M100907. In clinical trials, the drug has been referred to by both names. For example, the Phase 3 trial NCT00495885 is titled 'Efficacy and Safety of M100907 on Sleep Maintenance Insomnia,' confirming that M100907 is an alternative name for volinanserin.