Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azetukalner · 5 trials · 5 indications
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
| Arm | Type | Description |
|---|---|---|
| Azetukalner 20 mg | EXPERIMENTAL | - |
| Azetukalner | EXPERIMENTAL | Azetukalner 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Azetukalner | DRUG | Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks. |
| Placebo | DRUG | Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks |
Inclusion Criteria: * Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression. * Participant provides written informed consent to participate in the study, is able to understand the procedures and study req...
Azetukalner is an investigational small molecule being developed for the treatment of major depressive disorder, bipolar depression, and bipolar disorder. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Azetukalner is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XENE. The company is conducting Phase 3 clinical trials for this investigational drug.
Azetukalner is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials are currently recruiting or enrolling participants to evaluate its safety and efficacy.
Azetukalner is being studied in four Phase 3 clinical trials. These include NCT06775379 and NCT07076407, randomized placebo-controlled studies in major depressive disorder, and NCT06922110, an open-label study in major depressive disorder. NCT07217860 is an open-label study in bipolar I or II depression.
Yes, Azetukalner is being studied in bipolar disorder. The clinical trial NCT07217860, known as X-CEED-OLE, is an open-label Phase 3 study enrolling participants with bipolar I or II depression, including those with bipolar I disorder, bipolar II disorder, and bipolar depression.