Recruiting
Phase 3

Azetukalner

Sponsor:

Xenon Pharmaceuticals Inc.

Code:

NCT07172516

Conditions

Bipolar Disorder

Bipolar Depression

Bipolar I Disorder

Bipolar II Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Azetukalner

Placebo

Study Details

Brief summary:

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Conditions

Bipolar Disorder

Bipolar Depression

Bipolar I Disorder

Bipolar II Disorder

Study ID

NCT07172516

Start date

Aug 8, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
  • Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • Current MDE must has a duration of ≥4 weeks and ≤12 months.

Key Exclusion Criteria:

  • Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
  • Participant has any nonbipolar psychiatric diagnosis.
  • Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
  • Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
  • Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
  • Participant has been hospitalized for mania within the 30 days prior to screening visit.
  • Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
  • Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
  • Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
  • Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
  • Participants with medical conditions that may interfere with the purpose or conduct of the study.
  • Participant is pregnant, breastfeeding, or planning to become pregnant.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Azetukalner

Azetukalner 20 mg

placebo comparator: Placebo

Placebo

Interventions

Azetukalner

Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks

Placebo

Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Primary outcome measure

  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. [ Time Frame: Baseline to Week 6 ]

Central Contacts and Locations

Central contacts

Xenon Medical Affairs

1-604-484-3300XenonCares@xenon-pharma.com

Locations

Noble Clinical Research

Recruiting

Tucson, Arizona, United States, 85704

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Woodland Research Northwest

Recruiting

Rogers, Arkansas, United States, 72758

Clinical Innovations Inc

Recruiting

Bellflower, California, United States, 90706

ProScience Research Group

Recruiting

Culver City, California, United States, 90230

ATP Clinical Research

Recruiting

Orange, California, United States, 92866

NRC Research Institute

Recruiting

Orange, California, United States, 92868

Clinical Innovations Inc

Recruiting

Riverside, California, United States, 92506

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

PharmaSouth Research, LLC

Recruiting

Coral Gables, Florida, United States, 33146

Sarkis Clinical Research

Recruiting

Gainesville, Florida, United States, 32607

Clinical Neuroscience Solutions, LLC

Recruiting

Jacksonville, Florida, United States, 32256

Central Miami Medical Institute

Recruiting

Miami, Florida, United States, 33125

Clinical Neuroscience Solutions, LLC

Recruiting

Orlando, Florida, United States, 32801

Synexus Clinical Research, Inc.

Recruiting

Atlanta, Georgia, United States, 30328

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

CenExel iResearch

Recruiting

Decatur, Georgia, United States, 30030

Denali Health Atlanta, LLC

Recruiting

Stone Mountain, Georgia, United States, 30083

Revival Research Institute

Recruiting

Elgin, Illinois, United States, 60123

Advanced Quality Medical Research

Recruiting

Orland Park, Illinois, United States, 60462

Psychiatric Care and Research Center

Recruiting

O'Fallon, Missouri, United States, 63368

Redbird Clinical Research, LLC

Recruiting

Las Vegas, Nevada, United States, 89119

Lumina Clinical Research Center

Recruiting

Cherry Hill, New Jersey, United States, 08002

Bio Behavioral Health

Recruiting

Toms River, New Jersey, United States, 08755

Integrative Clinical Trials LLC

Recruiting

Brooklyn, New York, United States, 11229

Neurobehavioral Research Inc

Recruiting

Cedarhurst, New York, United States, 11516

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

Lehigh Center for Clinical Research

Recruiting

Allentown, Pennsylvania, United States, 18103

Clinical Neuroscience Solutions, LLC

Recruiting

Memphis, Tennessee, United States, 38119

Elevate Synapsis, LLC

Recruiting

Atascocita, Texas, United States, 77346

Memorial Hermann Village

Recruiting

Houston, Texas, United States, 77043

Grayline Research Center

Recruiting

Wichita Falls, Texas, United States, 76309

Core Clinical Research

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Xenon Pharmaceuticals Inc.

Last update posted

Sep 2, 2026

Last verified

Jun, 2026

Keywords

  • Bipolar
  • XEN1101
  • Azetukalner

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Xenon Pharmaceuticals Inc. on 2026-09-02.