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Also known as vestipitant
vestipitant/paroxetine · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Period 1 | OTHER | - |
| Period 2 | OTHER | - |
| Period 3 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Vestipitant | DRUG | NK1 receptor antagonist |
| Vestipitant + Paroxetine | DRUG | NK1 receptor antagonist and SSRI |
| Placebo | OTHER | Placebo |
| paroxetine | DRUG | - |
| vestipitant/paroxetine | DRUG | - |
Inclusion criteria: * Male or female subjects with a diagnosed tinnitus. * Subject with THI severity grade of 3 or 4. * Subjects willing to restrict alcohol intake. * The subject must have given written consent. * Women of childbearing potential who abstain from intercourse OR agree to birth contro...
Vestipitant/paroxetine is an investigational combination therapy developed by GSK plc for psychiatric conditions. It pairs vestipitant, a small-molecule TACR1 antagonist, with paroxetine, an antidepressant. The combination has been studied in Phase 2 trials for social phobia, tinnitus with hearing loss, and depressive and anxiety disorders.
Vestipitant/paroxetine has been studied in clinical trials for social phobia, tinnitus with hearing loss, and depressive and anxiety disorders. It is an investigational combination and is not an approved treatment. All reported studies were Phase 2 trials that have been completed.
Vestipitant, the novel component of the combination, targets TACR1, the neurokinin 1 receptor, and acts as an antagonist. Paroxetine is an antidepressant component of the combination. The TACR1 antagonist mechanism is intended to complement paroxetine in treating psychiatric conditions such as social phobia and anxiety disorders.
GSK plc, which trades under the ticker GSK, is the developer of the vestipitant/paroxetine combination. The company sponsored the Phase 2 clinical trials evaluating the combination in social phobia, tinnitus with hearing loss, and depressive and anxiety disorders.
Vestipitant/paroxetine is in Phase 2 development. It is an investigational combination therapy and has not been approved by the FDA. All three reported clinical trials of the combination were Phase 2 studies, and all have been completed.
Three completed Phase 2 trials have evaluated vestipitant/paroxetine: NCT00403962 in social anxiety disorder with 204 patients across Denmark, Germany, Norway, and South Africa; NCT00394056 in tinnitus and hearing loss with 26 patients in the United Kingdom; and NCT00343707, a PET and public speaking study in social anxiety patients in Sweden.
Vestipitant/paroxetine is a combination of vestipitant and paroxetine, so it is not the same as vestipitant alone. Vestipitant is the TACR1 antagonist component, and paroxetine is the antidepressant component. Trials have studied both vestipitant alone and the vestipitant/paroxetine combination.