XEN1101

Phase 3Small molecule

XXenon Pharmaceuticals Inc.

XEN1101 is one of 123 small molecule programs targeting Focal-onset seizure. It is currently in Phase 3.

Indications

Total Trials

Active Trials

122

Competitors

Pipeline

Status by Indication[3][1]

Indication

Focal-Onset SeizureActive, not recruiting

SeizureActive, not recruiting

EpilepsyActive, not recruiting

Major Depressive DisorderActive, not recruiting

Focal EpilepsyEnrolling by invitation

Tonic-Clonic SeizuresRecruiting

Focal-Onset SeizurePhase 3

Active, not recruiting

SeizurePhase 3

Active, not recruiting

EpilepsyPhase 2

Active, not recruiting

Major Depressive DisorderPhase 2

Active, not recruiting

Focal EpilepsyPhase 3

Enrolling by invitation

Tonic-Clonic SeizuresPhase 3

Recruiting

Competition

Competitive Landscape

386 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 2

Elavil

AstraZeneca

Phase 3

2 3

Daliresp

AstraZeneca

Phase 3

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

5 5

Nuplazid

AACADIA Pharmaceuticals Inc.

Phase 3

4 6

Ketalar

Boehringer Ingelheim

Phase 3

3 7

Latuda

SSunovion Respiratory Development Inc.

Phase 3

3 8

Versed

CConrado Roberto Hoffmann Filho

Phase 3

2 9

Celebrex

PPhiladelphia Eye Associates

Phase 3

2 10

Risperdal

WWim Janssens

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Focal-Onset Seizure

NCT05716100

Q2 2027

Phase 3Recruiting

Tonic-Clonic Seizures

NCT05667142

Q4 2028

Phase 2Active, not recruiting

Epilepsy

NCT03796962

Clinical

Trials by Indication[1]

Focal-onset seizure2 trials

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Completed·XXenon Pharmaceuticals Inc.·Phase 3·NCT05614063·380 enrolled

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Recruiting·XXenon Pharmaceuticals Inc.·Phase 3·NCT05716100·360 enrolled

Major Depressive Disorder2 trials

A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder

Completed·XXenon Pharmaceuticals Inc.·Phase 2·NCT05376150·168 enrolled

XEN1101 for Major Depressive Disorder

Completed·JJames Murrough·Phase 2·NCT04827901·44 enrolled

Epilepsy1 trial

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Active, not recruiting·XXenon Pharmaceuticals Inc.·Phase 2·NCT03796962·325 enrolled

Tonic-Clonic Seizures1 trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Recruiting·XXenon Pharmaceuticals Inc.·Phase 3·NCT05667142·160 enrolled

Focal Epilepsy1 trial

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

Enrolling by invitation·XXenon Pharmaceuticals Inc.·Phase 3·NCT05718817·880 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for XEN1101. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — XEN1101 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for XEN1101. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Xenon Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: XXenon Pharmaceuticals Inc.

XEN1101

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2028

Trials by Indication[1]

Focal-onset seizure2 trials

Major Depressive Disorder2 trials

Epilepsy1 trial

Tonic-Clonic Seizures1 trial

Focal Epilepsy1 trial

References

Drug Info

Quick Facts

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