Xenon Pharmaceuticals Inc. XENE
Xenon Pharmaceuticals Inc. (Nasdaq: XENE) is a CNS/neurology/psychiatry drug developer. Its lead program, azetukalner (XEN1101), is in Phase 3 for focal onset seizures (epilepsy). Its next catalyst on record is XEN1701: Complete Phase 1 SAD/MAD to support Phase 2 in acute pain (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: XEN1701 — Complete Phase 1 SAD/MAD to support Phase 2 in acute pain (H2 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| azetukalner X-TOLE3 (Phase 3) | focal onset seizures | small molecule | Phase 3 |
| azetukalner X-ACKT (Phase 3) | primary generalized tonic-clonic seizures | small molecule | Phase 3 |
| azetukalner X-NOVA2 / X-NOVA3 (Phase 3) | major depressive disorder | small molecule | Phase 3 |
| azetukalner X-CEED (Phase 3) | bipolar depression (BPD I or II) | small molecule | Phase 3 |
| XEN1701 (Nav1.7) | acute pain | small molecule | Phase 1 |
| XEN1720 (Nav1.7) | pain | small molecule | Phase 1 |
| XEN1120 (Kv7) | acute pain | small molecule | Phase 1 |
| NBI-921355 (partnered with Neurocrine; Nav1.2/Nav1.6) | epilepsy | small molecule | Phase 1 |
| Nav1.1 program | Dravet syndrome | small molecule | Pre-clinical |
Recent results and decisions
- Mar 9, 2026met Met primary endpoint: median percent change in monthly FOS frequency -53.2% (25 mg, p=0.000000000006) and -34.5% (15 mg, p=0.00007) vs -10.4% placebo; RR50 54.8% / 37.6% vs 20.8%.
The study met its primary endpoint of MPC in monthly FOS frequency from baseline to week 12 in both the 25 mg and 15 mg azetukalner dose groups compared to placebo [MPC of -53.2% (p=0.000000000006), -34.5% (p=0.00007) and -10.4%, respectively].
Filing - Nov 3, 2025completed enrollment Phase 3 X-TOLE2 completed enrollment with 380 patients randomized.
Phase 3 X-TOLE2 study of azetukalner in FOS has completed patient enrollment with 380 patients randomized and topline data anticipated in early 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.