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Clinical trials
catalyst calendar across sponsors →Studies where XENE is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
23 interventional · 6 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| An Open-label Study of XEN1101 in EpilepsyNCT05718817The adverse eventsOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: XEN1101 | Focal Epilepsy, Tonic-Clonic Seizures | 880 | Apr 2033 | ≤ 2,446 d | 2026-08-10 |
| An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)NCT07217860Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interestOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Azetukalner | Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder | 400 | Jun 2029 | ≤ 1,046 d | 2026-06-03 |
| A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)NCT07172516Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Azetukalner, Placebo | Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder | 400 | Jun 2028 | ≤ 681 d | 2026-06-03 |
| A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)NCT07076407Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Azetukalner, Placebo | Major Depressive Disorder | 450 | May 2027 | ≤ 285 d | 2026-08-03 |
| A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic SeizuresNCT05667142Median percent change (MPC) in monthly (28 days) PGTCS frequencyRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: XEN1101, Placebo | Primary Generalized Tonic-Clonic Seizures | 160 | Apr 2027 | ≤ 254 d | 2026-08-10 |
| An Open-Label Study of Azetukalner in Major Depressive DisorderNCT06922110Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interestOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Azetukalner | Major Depressive Disorder | 460 | Jan 2027 | ≤ 165 d | 2026-08-03 |
| A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)NCT05716100Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: XEN1101, Placebo | Focal Onset Seizures | 360 | Oct 2026 | ≤ 73 d | 2026-05-14 |
| A Randomized Study of Azetukalner Versus Placebo in Major Depressive DisorderNCT06775379Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Azetukalner, Placebo | Major Depressive Disorder | 450 | Aug 2026 | ≤ 12 d | 2026-08-03 |
| A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal EpilepsyNCT03796962results2024-09-24Median Percent Change in Focal Seizure FrequencyRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Active, not recruiting | Drug: XEN1101 | Focal Epilepsy | 325 | 2021-09-02actual | — | 2024-09-24 |
| A Randomized Study of XEN1101 Versus Placebo in Focal-Onset SeizuresNCT05614063Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: XEN1101, Placebo | Focal Onset Seizures | 380 | 2026-01-12actual | — | 2026-05-14 |
| An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEENCT04912856results2025-02-14Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to InterventionNon-randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan: Study Protocol ↗ · Statistical Analysis Plan: Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision; not a safety decision | Drug: XEN496 | Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epileptic Syndromes | 8 | 2023-11-17actual | — | 2025-02-14 |
| A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive DisorderNCT05376150Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: XEN1101 10 mg, XEN1101 20 mg, Placebo | Major Depressive Disorder | 168 | 2023-09-18actual | — | 2024-09-19 |
| XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic EncephalopathyNCT04639310results2024-08-23Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision; Not a safety decision | Drug: XEN496, Placebo | Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epileptic Syndromes | 8 | 2023-05-16actual | — | 2024-08-23 |
| Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.NCT03340220Parts 1 & 2: Number of Participants with Adverse Events (AEs)Non-randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: XPF-008, Microcrystalline Cellulose, XPF-010, Itraconazole 400mg | Healthy Volunteers | 130 | 2021-11-26actual | — | 2023-05-11 |
| Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101NCT04952467Total radioactivity excreted in urine and faeces following oral administration of XEN1101Open-label · Basic science | Phase 1 | Completed | Drug: 14C-XEN1101 | Healthy Volunteers | 6 | 2021-10-04actual | — | 2022-01-14 |
| Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901NCT03467100Number of Participants with Adverse Events (AEs) as assessed by CTCAE v4.03Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: XEN901, Inert Ingredients Oral Product | Healthy Volunteers | 70 | 2018-12-19actual | — | 2019-07-22 |
| Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101NCT03468725Number of participants with adverse events (AEs) as assessed by CTCAE v4.03Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: XPF-008, Microcrystalline Cellulose | Healthy Male Volunteers | 20 | 2018-07-31actual | — | 2018-09-18 |
| A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical GelNCT02656043Change from Baseline in acne lesion countRandomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: XPF-005, Placebo | Acne Vulgaris | 213 | 2017-02-16actual | — | 2019-01-22 |
| Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited ErythromelalgiaNCT01486446results2014-04-14Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2Randomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: XPF-002, Placebo | Primary Erythromelalgia, Inherited Erythromelalgia | 8 | Apr 2012actual | — | 2014-04-14 |
| A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)NCT01195636results2013-11-25Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: XPF-002, Placebo | Postherpetic Neuralgia | 70 | Mar 2011actual | — | 2013-11-25 |
| Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)NCT01090622Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)Randomized · Double-masked · Treatment | Phase 1/2 | Completed | Drug: XPF-001, Placebo | Primary Erythromelalgia, Inherited Erythromelalgia | 4 | Aug 2010actual | — | 2012-03-16 |
| Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth ExtractionNCT00954356results2012-06-29Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: XPF-001, placebo | Dental Pain | 61 | Nov 2009actual | — | 2012-07-16 |
| Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy VolunteersNCT00813670ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: XPF-001 | Healthy Human Volunteers | 64 | May 2009actual | — | 2009-09-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19