Approval Probability
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Adjusted LOA
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talnetant · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| talnetant | EXPERIMENTAL | 200mg, 400mg, 600mg) twice a day |
| placebo | PLACEBO_COMPARATOR | placebo |
| risperidone | ACTIVE_COMPARATOR | 3mg twice a day |
| Name | Type | Description |
|---|---|---|
| Talnetant | DRUG | talnetant |
| placebo | OTHER | Placebo Comparator |
| risperidone | OTHER | Active Comparator |
Inclusion criteria: * Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse. * Require inpatient hospitalization. * Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method. Exclusion crite...
Talnetant is an investigational small molecule developed by GSK plc (ticker GSK) that has been studied in Phase 2 clinical trials for schizophrenia and irritable colon, also known as irritable bowel syndrome. It is a TACR3 antagonist. It has not been approved by the FDA and remains a clinical-stage research compound.
Talnetant has been studied for two indications: schizophrenia and irritable colon, or irritable bowel syndrome. All of its clinical work has been in Phase 2 trials, and the program's trials are listed as completed. It is not an approved treatment for either condition.
Talnetant targets TACR3, also known as the neurokinin-3 receptor, and acts as an antagonist, meaning it blocks signaling at that receptor. This target class distinguishes it from dopamine-based antipsychotics, and the mechanism was the basis for testing it in schizophrenia and irritable bowel syndrome.
Talnetant is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 clinical program evaluating the compound in schizophrenia and irritable colon. No other developer is associated with the asset in the available trial record.
Talnetant is in Phase 2. All four of its registered trials were Phase 2 studies, and all are now completed, with no active trials ongoing. The compound is investigational and has not been approved by the FDA for any indication.
Talnetant has been evaluated in completed Phase 2 trials including NCT00300963 and NCT00103727, which compared it with risperidone and placebo in schizophrenia, NCT00049946 in adults with schizophrenia, and NCT00101985, an eight-week irritable bowel syndrome study run across the United States, Europe, Canada, Australia, and South Africa.