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Also known as volinanserin (M100907), M100907
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 developed by Sanofi for sleep initiation and maintenance disorders. It has been studied in Phase 3 clinical trials as a treatment for insomnia, specifically sleep maintenance insomnia. It is not approved and remains in clinical development.
Volinanserin is being developed for sleep initiation and maintenance disorders, including sleep maintenance insomnia. Two Phase 3 trials evaluated its efficacy and safety in adults with these conditions. One trial also included a sub-study in patients with stable Type II diabetes mellitus.
Volinanserin targets HTR2A, the serotonin 5-HT2A receptor, and acts as an antagonist at this receptor. By blocking HTR2A, the drug is designed to modulate serotonin signaling relevant to sleep regulation. This mechanism underlies its investigation for sleep maintenance insomnia.
Volinanserin is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the drug in sleep initiation and maintenance disorders.
Volinanserin is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
Volinanserin has been studied in two completed Phase 3 trials: NCT00495885, which enrolled 848 participants and included a sub-study in stable Type II diabetes, and NCT00464243, a polysomnographic study that enrolled 604 participants. Both were randomized, double-blind, placebo-controlled trials in adults with sleep initiation and maintenance disorders.
Yes, volinanserin is also known as M100907. Both names refer to the same Sanofi compound, an HTR2A antagonist studied in Phase 3 trials for sleep maintenance insomnia. Searches for M100907 and volinanserin refer to the same drug asset.