Drugs / Azetukalner
Azetukalner
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed focal epilepsy 1 milestone | |||||
| Filed | US (FDA) | — | focal epilepsy | 2019-03-06 | “An IND application for XEN1101 has been accepted by the FDA” xenon-pharma.com ↗ |
| Filed major depressive disorder 1 milestone | |||||
| Filed | US (FDA) | — | major depressive disorder | 2022-03-01 | “we have now filed an IND with the FDA to support the initiation of our company-sponsored Phase 2 XEN1101 clinical trial in major depressive disorder” xenon-pharma.com ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT04952467 | Jul → Oct 2021 | — | Xenon Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03468725 | Feb → Jul 2018 | — | Xenon Pharmaceuticals Inc. | Completed | Met primary |
| Phase 1 | NCT03340220 | Nov 2017 → Nov 2021 | — | Xenon Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05376150 | May 2022 → Sep 2023 | major depressive disorder | Xenon Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 2 | NCT03796962 | Jan 2019 → Sep 2021 overdue | focal epilepsy | Xenon Pharmaceuticals Inc. | Active not recruiting | Met primary |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT07217860 | Oct 2025 → Jun 2029 expected | bipolar I disorder, bipolar II disorder, bipolar depression | Xenon Pharmaceuticals Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT07172516 | Aug 2025 → Jun 2028 expected | bipolar I disorder, bipolar II disorder, bipolar depression | Xenon Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07076407 | Jul 2025 → May 2027 expected | major depressive disorder | Xenon Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06922110 | Mar 2025 → Jan 2027 expected | major depressive disorder | Xenon Pharmaceuticals Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06775379 | Dec 2024 → Aug 2026 overdue | major depressive disorder | Xenon Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05716100 | May 2023 → Oct 2026 expected | focal epilepsy | Xenon Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05718817 | Apr 2023 → Apr 2033 expected | epilepsy with generalized tonic-clonic seizures, focal epilepsy | Xenon Pharmaceuticals Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05667142 | Feb 2023 → Apr 2027 expected | epilepsy with generalized tonic-clonic seizures | Xenon Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05614063 | Nov 2022 → Jan 2026 | focal epilepsy | Xenon Pharmaceuticals Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04827901 Comparator | Oct 2021 → Oct 2024 | major depressive disorder | James Murrough | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-04-19 | Xenon Pharmaceuticals Inc. | Results Xenon Presents Azetukalner Phase 3 X-TOLE2 Study Results and 48-Month Long-term Data in Focal Onset Seizures at 2026 AAN Annual Meeting xenon-pharma.com ↗
Long-term data from the ongoing X-TOLE OLE study at 48 months show nearly 40% of participants achieving at least 12 months of seizure freedom and one in four participants achieving at least 24 months of seizure freedom |
| 2026-03-09 | Xenon Pharmaceuticals Inc. | Results Xenon Announces Positive Topline Data from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures (FOS) xenon-pharma.com ↗ |
| 2025-12-05 | Xenon Pharmaceuticals Inc. | Results Xenon Showcases New 48-Month Azetukalner OLE Study Data in Epilepsy at AES 2025 xenon-pharma.com ↗
Monthly reductions in seizure frequency of 90.9% among participants treated for ≥48 months in the OLE, with 38% achieving ≥1 year of seizure freedom |
| 2025-11-25 | Xenon Pharmaceuticals Inc. | Results Xenon to Present New Azetukalner OLE Study Data in Epilepsy at AES 2025 xenon-pharma.com ↗ |
| 2025-04-04 | Xenon Pharmaceuticals Inc. | Results Xenon to Showcase Long-Term 36-Month Azetukalner Data at AAN 2025 xenon-pharma.com ↗
Three posters will be presented, including long-term data from the ongoing X-TOLE open-label extension (OLE) study of azetukalner in patients with focal onset seizures (FOS). |
| 2024-12-06 | Xenon Pharmaceuticals Inc. | Results Xenon Showcases New Long-Term Azetukalner Data from X-TOLE OLE Study in FOS at AES 2024 xenon-pharma.com ↗
OLE data shows sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and consistent AE safety profile suggesting long-term efficacy and tolerability of azetukalner |
| 2024-09-09 | Xenon Pharmaceuticals Inc. | Results Xenon Showcases Azetukalner Data at 15th European Epilepsy Congress xenon-pharma.com ↗ |
| 2024-05-28 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Presents Data from Phase 2 X-NOVA Clinical Trial of Azetukalner in Major Depressive Disorder at the American Society of Clinical Psychopharmacology 2024 Annual Meeting xenon-pharma.com ↗
The X-NOVA results demonstrated a clinically meaningful reduction in depression, in addition to an early onset of action, a significant reduction in anhedonia, and a potentially differentiated safety profile of azetukalner as compared to other antidepressants. |
| 2023-12-02 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Provides Updates on Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2023) xenon-pharma.com ↗
These new data demonstrate impressive seizure freedom rates, including almost one in four patients who were on treatment for at least two years achieving at least 12 months of consecutive seizure freedom. |
| 2023-11-27 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept X-NOVA Clinical Trial of XEN1101 in Major Depressive Disorder (MDD) xenon-pharma.com ↗
A clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group (p=0.135) was observed. |
| 2023-10-09 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b “X-TOLE” Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology xenon-pharma.com ↗ |
| 2023-09-04 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Showcases XEN1101 Epilepsy Program at 35th International Epilepsy Congress xenon-pharma.com ↗
New interim data from ongoing Phase 2b X-TOLE open-label extension demonstrates improvement in overall quality-of-life (QoL) when compared to baseline |
| 2022-12-02 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Provides Updates on Proprietary Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2022) xenon-pharma.com ↗
This interim analysis shows XEN1101 continues to be generally well-tolerated, yielding long-term efficacy at the 20 mg once-daily dose, with patients experiencing continued seizure reduction during the OLE and extended periods of seizure freedom. |
| 2022-06-22 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Provides Update on Additional Positive Data from the XEN1101 Program xenon-pharma.com ↗
Additionally, within our analysis of the open label extension (OLE) population, we are seeing seizure frequency continuing to improve after the double-blind period with patients experiencing increased periods of seizure freedom. |
| 2021-12-03 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Presents Additional Positive Data from Phase 2b ‘X-TOLE’ Clinical Trial at the Annual Meeting of the American Epilepsy Society (AES 2021) xenon-pharma.com ↗
Topline Data Showed All Primary and Secondary Seizure Reduction Endpoints Statistically Significant Across All Dose Groups, with p-value of <0.001 for 20 mg and 25 mg Dose Groups |
| 2021-10-04 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Announces Positive Topline Results from Phase 2b ‘X-TOLE’ Clinical Trial of XEN1101 for the Treatment of Focal Epilepsy xenon-pharma.com ↗
The trial met its primary efficacy endpoint with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly (defined as 28 days) focal seizure frequency when compared to placebo (monotonic dose response; p<0.001). |
| 2021-03-08 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Pharmaceuticals Announces Collaboration with Researchers at Icahn School of Medicine at Mount Sinai to Conduct a Phase 2 Study of XEN1101 for the Treatment of Major Depressive Disorder (MDD) xenon-pharma.com ↗
The U.S. Food and Drug Administration (FDA) has accepted the IND |
| 2021-02-22 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Announces Promising New Pre-Clinical Data and Provides Clinical Overview of its XEN1101 Program at ASENT 2021 xenon-pharma.com ↗
A pipeline presentation entitled “Depression and Anhedonia: Acute Pre-clinical Efficacy for XEN1101, a Differentiated Kv7 Potassium Channel Modulator” included new pre-clinical data from the Forced Swim Test and Progressive Ratio Test animal models, which support a potential benefit of XEN1101 in mood disorders. |
| 2019-01-28 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Provides Key Regulatory Updates on XEN007 and XEN1101 xenon-pharma.com ↗
Xenon Eligible to Apply for Priority Review Voucher IND for XEN1101 Accepted |
| 2018-12-03 | Xenon Pharmaceuticals Inc. | Results Xenon Announces Final Results of XEN1101 Phase 1 Clinical Trial and Update on XEN901 Phase 1 Clinical Trial at the American Epilepsy Society (AES) Annual Meeting xenon-pharma.com ↗
Xenon announced final results from its XEN1101 Phase 1 clinical trial and the related transcranial magnetic stimulation (TMS) studies, along with interim results from its XEN901 Phase 1 clinical trial, in posters at the American Epilepsy Society (AES) Annual Meeting held in New Orleans, LA. |
| 2018-08-29 | Xenon Pharmaceuticals Inc. | Results Xenon Announces Positive XEN1101 Pharmacodynamic Data from Phase 1b TMS Study xenon-pharma.com ↗
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage, neurology-focused biopharmaceutical company, today announced positive data from its XEN1101 Phase 1b transcranial magnetic stimulation (TMS) study. |
| 2018-05-15 | Xenon Pharmaceuticals Inc. | Results Xenon Presents Positive XEN1101 TMS Pharmacodynamic Phase 1 Data at 14th Eilat Conference xenon-pharma.com ↗
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today presented positive interim data from its ongoing XEN1101 Phase 1 clinical trial in a podium presentation at the 14thEilat Conference on New Antiepileptic Drugs and Devices (Eilat) held in Madrid, Spain. |
All press releases naming this drug 37 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azetukalner | “Azetukalner, a Novel KV7 Potassium Channel Opener, in Adults With Major Depressive Disorder: A Randomized Clinical Trial.” PMID 40423966 ↗ May 2025 |
| Known as | Encukalner | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095264 ↗ |
| Known as | XEN1101 | “Capsule filled with XEN1101” NCT03340220 ↗8“Capsule filled with XEN1101” NCT03468725 ↗ |
| Action | Activate | “potassium channel opener” PMID 37812429 ↗ Nov 2023 |
| Modality | Small molecule | “a novel small-molecule selective Kv7.2/Kv7.3 potassium channel opener” PMID 37812429 ↗ Nov 2023 |
| Route | Oral | “Single oral dose for each cohort” NCT03340220 ↗ |