XEN1101 Clinical Trials (2026): 8 Studies for Focal Epilepsy & Focal Onset Seizures
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
8 XEN1101 clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 5 indications (including Focal Epilepsy & Focal Onset Seizures) and 2,323 total planned enrollment. 4 Phase 3 XEN1101 trials and 3 Phase 2 are listed. 3 XEN1101 clinical trials are actively recruiting at 68 U.S. sites across 27 states. Most recent activity: NCT05718817 (Jun 2033).
Where to Participate: All XEN1101 Trial Sites in the U.S. (68 sites across 27 states)
Every actively recruiting XEN1101trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | University of Alabama - Strada Patient Care Center, Neurology | Mobile36604 | NCT05667142 | Map |
| AZ | Xenoscience | Phoenix85004 | NCT05667142 | Map |
| AZ | University of Arizona - Health Science Center | Tucson85724 | NCT05667142 | Map |
| AR | Clinical Trials, Inc. | Little Rock72205 | NCT05716100 | Map |
| AR | University of Arkansas for Medical Sciences | Little Rock72205 | NCT05667142 | Map |
| CA | Rancho Research Institute | Downey90242 | NCT05716100 | Map |
| CA | Brain Science Research Institute | Los Angeles90025 | NCT05667142 | Map |
| CA | University of California Los Angeles (UCLA) | Los Angeles90095 | NCT05716100 | Map |
| CA | University of California Irvine Health | Orange92868 | NCT05716100 | Map |
| CA | University of California, Irvine - Health Neurology Services | Orange92868 | NCT05667142 | Map |
| CO | University of Colorado Anschutz Medical Campus | Aurora80045 | NCT05667142 | Map |
| FL | Panhandle Research and Medical Clinic | Gulf Breeze32651 | NCT05716100 | Map |
| FL | Mayo Clinic Florida | Jacksonville32224 | NCT05667142 | Map |
| FL | Mayo Clinic Florida | Jacksonville32224 | NCT05716100 | Map |
| FL | Serenity Research Center, LLC | Miami33176 | NCT05667142 | Map |
| FL | Panhandle Research and Medical Clinic | Pensacola32503 | NCT05667142 | Map |
| FL | Medsol Clinical Research Center Harbor Professional Centre | Port Charlotte33952 | NCT05667142 | Map |
| FL | University of South Florida | Tampa33606 | NCT05667142 | Map |
| FL | Encore Medical Research of Weston, LLC | Weston33331 | NCT05667142 | Map |
| GA | Children's Healthcare of Atlanta | Atlanta30342 | NCT05667142 | Map |
| GA | Emory Brain Health Center | Atlanta30329 | NCT05667142 | Map |
| HI | Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center | Honolulu96817 | NCT05667142 | Map |
| ID | Consultants in Epilepsy and Neurology, PLLC | Boise83702 | NCT05667142 | Map |
| ID | Consultants in Epilepsy and Neurology, PLLC | Boise83702 | NCT05716100 | Map |
| IL | Southern Illinois University School of Medicine | Springfield62794 | NCT05667142 | Map |
| IL | Southern Illinois University School of Medicine | Springfield62794 | NCT05716100 | Map |
| KS | University of Kansas Medical Center | Kansas City66160 | NCT05667142 | Map |
| KY | Bluegrass Epilepsy Research, LLC | Lexington40504 | NCT05667142 | Map |
| KY | University of Kentucky Albert B. Chandler Hospital (UK Healthcare) | Lexington40536 | NCT05667142 | Map |
| MD | MedStar Franklin Square Medical Center | Baltimore21237 | NCT05667142 | Map |
| MD | University of Maryland Medical Center | Baltimore21201 | NCT05667142 | Map |
| MD | Mid-Atlantic Epilepsy and Sleep Center | Bethesda20817 | NCT05667142 | Map |
| MD | Mid-Atlantic Epilepsy and Sleep Center | Bethesda20817 | NCT05716100 | Map |
| MD | Medstar Georgetown University Hospital | Clinton20735 | NCT05667142 | Map |
| MA | Brigham and Women's Hospital | Chestnut Hill02467 | NCT05667142 | Map |
| MA | UMass Memorial Medical Center | Worcester01655 | NCT05667142 | Map |
| MI | University of Michigan Hospitals | Ann Arbor48109 | NCT05667142 | Map |
| MI | 9D University Health Center | Detroit48201 | NCT05716100 | Map |
| MI | Wayne State University | Detroit48201 | NCT05667142 | Map |
| MI | Michigan State University Department of Neurology | East Lansing48824 | NCT05667142 | Map |
| MI | Spectrum Health | Grand Rapids49503 | NCT05667142 | Map |
| MO | Saint Louis University Medical School | St Louis14624 | NCT05667142 | Map |
| NJ | Northeast Regional Epilepsy Group | Hackensack07601 | NCT05667142 | Map |
| NJ | Northeast Regional Epilepsy Group | Hackensack07601 | NCT05716100 | Map |
| NY | SUNY Upstate Medical University | Syracuse13201 | NCT05667142 | Map |
| NC | Atrium Health | Charlotte28203 | NCT05667142 | Map |
| NC | Onsite Clinical Solutions, LLC | Charlotte28211 | NCT05667142 | Map |
| NC | Duke University Clinic | Durham27705 | NCT05716100 | Map |
| NC | Duke University Clinical Research | Durham27710 | NCT05667142 | Map |
| NC | Wake Forest Baptist Health | Winston-Salem27104 | NCT05667142 | Map |
| OH | Summa Health Clinical Research Center | Akron44304 | NCT05667142 | Map |
| OH | Cleveland Clinic | Cleveland44195 | NCT05716100 | Map |
| OH | Cleveland Clinic Foundation | Cleveland44195 | NCT05667142 | Map |
| OH | OhioHealth | Columbus43214 | NCT05716100 | Map |
| OH | OhioHealth Riverside Methodist Hospital | Columbus43214 | NCT05667142 | Map |
| OH | The Ohio State University | Columbus43210 | NCT05667142 | Map |
| OR | Providence Neurological Specialities | Portland97225 | NCT05716100 | Map |
| PA | Temple University Hospital | Philadelphia19140 | NCT05667142 | Map |
| PA | University of Pennsylvania | Philadelphia19104 | NCT05667142 | Map |
| PA | UPMC Comprehensive Epilepsy Center | Pittsburgh15213 | NCT05667142 | Map |
| TN | Vanderbilt University Medical Center | Nashville37232 | NCT05716100 | Map |
| TX | Austin Epilepsy Care Center | Austin78758 | NCT05716100 | Map |
| TX | ANESC Research | El Paso79912 | NCT05667142 | Map |
| TX | UTHealth Science Center at Houston | Houston77030 | NCT05667142 | Map |
| TX | University of Texas Health Science Center at San Antonio | San Antonio78229 | NCT05667142 | Map |
| VA | Sentara Neurology Specialists | Virginia Beach23456 | NCT05667142 | Map |
| WA | University of Washington, Regional Epilepsy Center at Harborview Medical Center | Seattle98104 | NCT05667142 | Map |
| WI | Advocate Aurora Research institute, St. Luke's Medical Center | Milwaukee53215 | NCT05667142 | Map |
XEN1101 clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | enrolling by invitation | completed | Total |
|---|---|---|---|---|---|
| P1 | 1 | 1 | |||
| P2 | 1 | 2 | 3 | ||
| P3 | 2 | 1 | 1 | 4 |
Recruiting XEN1101 clinical trials (3)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT05718817 | X-TOLE4An Open-label Study of XEN1101 in Epilepsy | P3 | Focal Epilepsy | 880 | Apr 2023 |
| NCT05667142 | X-ACKTA Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures | P3 | Primary Generalized Tonic-Clonic Seizures | 160 | Feb 2023 |
| NCT05716100 | X-TOLE3A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) | P3 | Focal Onset Seizures | 360 | May 2023 |
XEN1101 clinical trials by indication
Focal Onset Seizures (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05716100 | X-TOLE3 | P3 | recruiting | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) |
| NCT05614063 | X-TOLE2 | P3 | completed | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures |
Focal Epilepsy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05718817 | X-TOLE4 | P3 | enrolling by invitation | An Open-label Study of XEN1101 in Epilepsy |
| NCT03796962 | X-TOLE | P2 | active not recruiting | A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy |
Major Depressive Disorder (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04827901 | — | P2 | completed | XEN1101 for Major Depressive Disorder |
| NCT05376150 | X-NOVA | P2 | completed | A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder |
Primary Generalized Tonic-Clonic Seizures (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05667142 | X-ACKT | P3 | recruiting | A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures |
Healthy Volunteers (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04952467 | — | P1 | completed | Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101 |
XEN1101 pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| X-TOLE4 | NCT05718817 | P3 | enrolling by invitation | Focal Epilepsy | 880 | — |
| X-ACKT | NCT05667142 | P3 | recruiting | Primary Generalized Tonic-Clonic Seizures | 160 | — |
| X-TOLE3 | NCT05716100 | P3 | recruiting | Focal Onset Seizures | 360 | — |
| X-TOLE2 | NCT05614063 | P3 | completed | Focal Onset Seizures | 380 | — |
| X-TOLE | NCT03796962 | P2 | active not recruiting | Focal Epilepsy | 325 | PMID 37812429 |
| X-NOVA | NCT05376150 | P2 | completed | Major Depressive Disorder | 168 | PMID 40423966 |
All XEN1101 trials (8)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05718817 | X-TOLE4 | An Open-label Study of XEN1101 in Epilepsy | P3 | enrolling by invitation | 880 | Xenon Pharmaceuticals Inc. | Apr 2023 |
| NCT03796962 | X-TOLE | A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy | P2 | active not recruiting | 325 | Xenon Pharmaceuticals Inc. | Jan 2019 |
| NCT05667142 | X-ACKT | A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures | P3 | recruiting | 160 | Xenon Pharmaceuticals Inc. | Feb 2023 |
| NCT05716100 | X-TOLE3 | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) | P3 | recruiting | 360 | Xenon Pharmaceuticals Inc. | May 2023 |
| NCT05614063 | X-TOLE2 | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures | P3 | completed | 380 | Xenon Pharmaceuticals Inc. | Nov 2022 |
| NCT04827901 | XEN1101 for Major Depressive Disorder | P2 | completed | 44 | James Murrough | Oct 2021 | |
| NCT05376150 | X-NOVA | A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder | P2 | completed | 168 | Xenon Pharmaceuticals Inc. | May 2022 |
| NCT04952467 | Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101 | P1 | completed | 6 | Xenon Pharmaceuticals Inc. | Jul 2021 |
XEN1101 clinical trials: frequently asked questions
- How many XEN1101 clinical trials are there?
- 8 XEN1101 clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 4 are marked completed.
- Are XEN1101 clinical trials recruiting in 2026?
- Yes — 3 XEN1101 trials are actively recruiting in 2026, with 68 U.S. sites across 27 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is XEN1101 being studied for?
- XEN1101 is being studied for Focal Epilepsy, Focal Onset Seizures, Major Depressive Disorder, Healthy Volunteers, Primary Generalized Tonic-Clonic Seizures and 1 more. The trials are grouped by indication on this page.
- What phase is XEN1101 in?
- XEN1101 clinical trials span 4 Phase 3, 3 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors XEN1101 clinical trials?
- The lead sponsor across the most XEN1101 trials is Xenon Pharmaceuticals Inc., with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming XEN1101as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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