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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 13, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07217860). This is a study registration, not published results. Lead sponsor: Xenon Pharmaceuticals Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder. Interventions: DRUG: Azetukalner. Primary outcome measures: Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest , From the start of treatment in the open-label extension study through 8 weeks after the last dose. Brief summary: X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.