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New depression drug tested for Long-Term safety and effectiveness

NCT ID NCT06922110

Disease control Sponsor: Xenon Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study looks at the long-term safety and effectiveness of azetukalner in adults with major depressive disorder. Participants must have successfully completed a previous phase 3 study of this drug. The goal is to monitor side effects and track changes in depression symptoms over time.

Why investors are watching

Xenon Pharmaceuticals is running a Phase 3 open-label study of azetukalner as a long-term treatment for major depressive disorder in 460 adults who finished an earlier Phase 3 trial. For a small company, this readout matters because it tests whether the drug remains safe and effective over time, which is a key step toward regulatory approval and commercial launch.

If it works: A positive result could support Xenon's application to regulators and position azetukalner as a new option for depression. That would give the company a potential revenue-generating product in a large treatment area.

If it fails: The trial could show safety problems or weak long-term efficacy, which would delay or block approval. Clinical trials fail often, and an open-label design without a placebo makes it harder to prove the drug works beyond patient and doctor expectations.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 460 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD. * Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them. * Participant is willing to comply with the contraception requirements. * Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug. Exclusion Criteria: * Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study. * Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study. * Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator. * Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol. * Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug. * Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study. * Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites - Lakeland

    Lakeland, Florida, 33803, United States

  • Accel Research Sites - St. Petersburg-Largo

    Largo, Florida, 33777, United States

  • Adams Clinical - Boston

    Boston, Massachusetts, 02116, United States

  • Adams Clinical - Watertown

    Watertown, Massachusetts, 02472, United States

  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Advanced Discovery Research, Llc

    Atlanta, Georgia, 30318, United States

  • Advanced Quality Medical Research, LLC

    Orland Park, Illinois, 60462, United States

  • Artemis Institute For Clinical Research - San Diego

    San Diego, California, 92123, United States

  • Atp Clinical Research

    Orange, California, 92866, United States

  • Austin Clinical Trial Partners

    Austin, Texas, 78737, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • Bioscience Research Llc.

    Mount Kisco, New York, 10549, United States

  • Boeson Research Pvu

    Provo, Utah, 84604, United States

  • Boston Clinical Trials Llc

    Boston, Massachusetts, 02131, United States

  • Calneuro Research Group, Inc.

    Los Angeles, California, 90025, United States

  • Cenexel Cit - Bellflower

    Bellflower, California, 90706, United States

  • Cenexel Cnr - Sherman Oaks

    Sherman Oaks, California, 91403-2131, United States

  • Cenexel Cns - Torrance

    Torrance, California, 90501, United States

  • Cenexel Iresearch - Atlanta

    Decatur, Georgia, 30030, United States

  • Cenexel Iresearch - Savannah

    Savannah, Georgia, 31405, United States

  • Center For Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Neuroscience Solutions Llc

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions Llc.

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, LLC

    Memphis, Tennessee, 38119, United States

  • Cns Clinical Research - Coral Springs

    Coral Springs, Florida, 33067, United States

  • Combined Research Orlando Phase I-Iv

    Orlando, Florida, 32807, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Ct Clinical Research Associates

    Cromwell, Connecticut, 06416, United States

  • DelRicht Research

    Atlanta, Georgia, 30329, United States

  • Delricht Research - Plano

    Plano, Texas, 75024, United States

  • Elixia MA, LLC

    Springfield, Massachusetts, 01103, United States

  • Equipath Health and Research Tampa Bay, Llc

    Riverview, Florida, 33578, United States

  • Excell Research Inc.

    Oceanside, California, 92056, United States

  • Fieve Clinical Research (Fcr), Inc.

    New York, New York, 10017-1921, United States

  • Global Medical Institutes - Princeton Medical Institute

    Princeton, New Jersey, 08540, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912, United States

  • Harmony Clinical Research Inc

    North Miami Beach, Florida, 33162, United States

  • IMA Clinical Research

    Chicago, Illinois, 60634, United States

  • Ima Clinical Research - Las Vegas

    Las Vegas, Nevada, 89102, United States

  • Ima Clinical Research - Nyc Uptown

    New York, New York, 10128, United States

  • Ima Clinical Research - Phoenix

    Phoenix, Arizona, 85012, United States

  • Insight Clinical Trials Llc

    Independence, Ohio, 44131, United States

  • Institute of Living - Clinical Trials Unit

    Hartford, Connecticut, 06106, United States

  • Integrative Clinical Trials, Llc

    Brooklyn, New York, 11229, United States

  • Irvine Clinical Research

    Irvington District, California, 92614, United States

  • Lehigh Center For Clinical Research

    Allentown, Pennsylvania, 18103, United States

  • Magnolia Clinical Research

    Cary, North Carolina, 27511, United States

  • Neoclinical Research

    Hialeah, Florida, 33016, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Nrc Research Institute

    Orange, California, 92868, United States

  • Oulu Mentalcare Oy

    Oulu, 90100, Finland

  • Pacific Clinical Research Management

    Upland, California, 91786, United States

  • Pahl Pharmaceutical Professionals Llc

    Oklahoma City, Oklahoma, 73112, United States

  • Panhandle Research and Medical Clinic

    Pensacola, Florida, 32502, United States

  • Pharmasite Research Inc.

    Baltimore, Maryland, 21208-6605, United States

  • Pharmasouth Research

    Coral Gables, Florida, 33146, United States

  • Praktyka Lekarska Malgorzata Wojtanowska-Bogacka - Centrum Badań Klinicznych

    Poznan, 60192, Poland

  • Psych Atlanta, Pc

    Marietta, Georgia, 30060, United States

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368, United States

  • Redbird Research

    Las Vegas, Nevada, 89119, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Sanro Clinical Research Group, Llc

    Bryant, Arkansas, 72022, United States

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73116, United States

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Synexus - Atlanta

    Atlanta, Georgia, 30328, United States

  • Vitalix Clinical - Worcester

    Worcester, Massachusetts, 01608, United States

  • Woodland International Research Group

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.