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Also known as Eplivanserin (SR46349), SR46349
Eplivanserin · 7 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| Eplivanserin | EXPERIMENTAL | Eplivanserin 5 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo of Eplivanserin 5 mg/day |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | PLACEBO_COMPARATOR | - |
| Age Group 6-11 year old - Dose level 1 | EXPERIMENTAL | - |
| Age Group 6-11 year old - Dose Level 2 | EXPERIMENTAL | - |
| Age Group 6-11 year old - Dose Level 3 | EXPERIMENTAL | - |
| Age Group 12-17 year old - Dose level 1 | EXPERIMENTAL | - |
| Age Group 12-17 year old - Dose level 2 | EXPERIMENTAL | - |
| Age Group 12-17 year old - Dose level 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Eplivanserin | DRUG | one 5 mg tablet once a day |
| Placebo | DRUG | Placebo of Eplivanserin one tablet once a day |
| eplivanserin (SR46349) | DRUG | 5 mg/day |
| lormetazepam | DRUG | 1 mg/day |
Inclusion Criteria: * Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria Exclusion Criteria: * Inpatients. * Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening nigh...
Eplivanserin is an investigational small molecule developed by Sanofi for sleep related conditions. It has been studied in fibromyalgia, primary insomnia, and sleep initiation and maintenance disorders. Development reached Phase 2, and the program includes five completed clinical trials with a combined enrollment of about 3,054 participants.
Eplivanserin targets HTR2A, also known as the serotonin 5-HT2A receptor, and acts as an antagonist at this receptor. Antagonist activity means the compound blocks signaling through the receptor rather than activating it. This target class distinguishes it from many older sleep medications that act through other receptor systems.
Eplivanserin is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical program, including the Phase 3 insomnia studies and the Phase 2 fibromyalgia study. The compound is also identified in research records by the code SR46349 and the ChEMBL identifier CHEMBL257704.
Eplivanserin is in Phase 2 development and is not approved. Its clinical program includes Phase 1, Phase 2, and Phase 3 studies, all of which are completed, with no trials currently active. The Phase 2 work covered sleep disorders in fibromyalgia, while Phase 3 studies focused on primary insomnia and sleep maintenance difficulties.
Five completed trials have evaluated eplivanserin. These include NCT00913614, a Phase 1 single dose study in children with insomnia; NCT00805350, a Phase 3 study in primary insomnia; NCT00679900, a Phase 3 comparison with lormetazepam in insomnia; and NCT00313885, a Phase 2 study in fibromyalgia with sleep disorders.
Yes, eplivanserin is also known as SR46349 and SR46349B. These are alternate identifiers used for the same compound in study titles and research records, so searches for SR46349 refer to eplivanserin. The drug is additionally indexed under the ChEMBL identifier CHEMBL257704.