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XEN1101

Phase 3

Focal Epilepsy | Small molecule | Neurology |Xenon Pharmaceuticals Inc.|Last Updated: Jul 8, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,205
FDA Designations
No designations recorded
Clinical trial landscape

XEN1101 · 6 trials · 5 indications

Phase 3 4Phase 2 2
NCT05716100A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)Focal Onset Seizures
RECRUITING360 Analytics
NCT05718817An Open-label Study of XEN1101 in EpilepsyFocal Epilepsy
ENROLLING BY_INVITATION880 Analytics
NCT05667142A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic SeizuresPrimary Generalized Tonic-Clonic Seizures
RECRUITING160 Analytics
NCT05614063A Randomized Study of XEN1101 Versus Placebo in Focal-Onset SeizuresFocal Onset Seizures
COMPLETED380 Analytics
PHASE3RECRUITING
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Focal Onset Seizures
NCT05716100360
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PHASE3ENROLLING BY_INVITATION
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy
NCT05718817880
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PHASE3RECRUITING
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures
NCT05667142160
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PHASE3COMPLETED
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Focal Onset Seizures
NCT05614063380
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Study Endpoints
Primary Endpoints
Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
From baseline through to the double blind period (week 12).
The adverse events
From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.

To assess the safety and tolerability of XEN1101

Median percent change (MPC) in monthly (28 days) PGTCS frequency
Baseline through DBP (Week 12)

Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.

Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
From baseline through to the double blind period (week 12)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
From baseline to end of treatment (Week 6).
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
From randomization to Week 10.
Median Percent Change in Focal Seizure Frequency
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)

Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo

Secondary Endpoints
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
From baseline through to the double blind period (week 12).
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
From baseline through to the week 1.
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
From baseline through to the double blind period (week 12).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XEN1101 25 mg/dayEXPERIMENTALXEN1101 25 mg/day
XEN1101 15 mg/dayEXPERIMENTALXEN1101 15 mg/day
PlaceboPLACEBO_COMPARATORPlacebo
XEN1101 15 or 25 mg/dayEXPERIMENTALXEN1101 15 or 25 mg/day
XEN1101 10 mgEXPERIMENTALDuring the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
XEN1101 20 mgEXPERIMENTALDuring the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
25 mg XEN1101EXPERIMENTALCapsule filled with 25 mg XEN1101
20 mg XEN1101EXPERIMENTALCapsule filled with 20 mg XEN1101
10 mg XEN1101EXPERIMENTALCapsule filled with 10 mg XEN1101
Interventions
NameTypeDescription
XEN1101DRUGXEN1101 Capsules
PlaceboDRUGPlacebo Capsules
XEN1101 10 mgDRUGXEN1101 oral capsule
XEN1101 20 mgDRUGXEN1101 oral capsule
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites95

Inclusion Criteria: * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study * Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must ha...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBulgariaChileCroatiaCzechiaFinlandFranceGermanyHungaryIsraelItalyMexicoNetherlandsPolandPortugalSpainCanadaGeorgiaIrelandNew ZealandUnited KingdomLatviaMoldovaUkraine
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Recent Changes (Last 90 Days)
LOWJul 8, 2026NCT05667142lastUpdatePostDate: changed
LOWJul 8, 2026NCT05718817lastUpdatePostDate: changed
LOWJul 8, 2026NCT05667142lastUpdatePostDate: changed
LOWJul 8, 2026NCT05718817lastUpdatePostDate: changed
MEDIUMJun 14, 2026NCT05614063TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT05614063TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT05614063TRIAL_REMOVED: changed
LOWJun 4, 2026NCT05667142lastUpdatePostDate: changed
LOWJun 4, 2026NCT05667142lastUpdatePostDate: changed
LOWJun 4, 2026NCT05667142lastUpdatePostDate: changed
LOWJun 4, 2026NCT05667142lastUpdatePostDate: changed
LOWJun 4, 2026NCT05667142lastUpdatePostDate: changed
LOWMay 26, 2026NCT05716100primaryCompletionDate: changed
LOWMay 26, 2026NCT05667142primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT05718817primaryCompletionDate: changed
LOWMay 26, 2026NCT03796962primaryCompletionDate: changed
LOWMay 24, 2026NCT05716100studyFirstPostDate: changed
LOWMay 24, 2026NCT05667142studyFirstPostDate: changed
LOWMay 24, 2026NCT05718817studyFirstPostDate: changed