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New depression pill could lift the fog: phase 3 trial underway

NCT ID NCT07076407

Symptom relief 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 study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 4 times

Summary

This study tests an experimental drug called azetukalner in 450 adults with moderate-to-severe major depression. Participants take the drug or a placebo daily for 6 weeks to see if it reduces depression symptoms like low mood and loss of pleasure. The goal is to find a new treatment option for people who need better symptom control.

Why investors are watching

Xenon Pharmaceuticals is running a Phase 3 trial of its drug azetukalner in 450 adults with moderate-to-severe major depressive disorder. The trial compares the drug against a placebo to see if it eases symptoms safely. For a small company like Xenon, this readout is a major test of whether its lead drug can succeed in a large, competitive market.

If it works: A positive result could show that azetukalner works as a depression treatment, which might lead to regulatory approval and a new revenue source for Xenon. That outcome would validate the company's research and strengthen its position.

If it fails: Phase 3 trials often fail, and a negative or unclear result could delay or end the drug's development, hurting Xenon's prospects. A safety problem would also raise serious concerns about the drug's future.

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 450 people

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

Started

Jul 2025

Expected to finish

Jul 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 to 74 years

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.

Key Inclusion Criteria: * Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age * Body Mass Index (BMI) ≤40 kg/m2 * Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI) * Participant's current MDE has a duration of ≥6 weeks and ≤24 months. Key Exclusion Criteria: * Participant has a primary diagnosis of a mood disorder other than MDD. * Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder. * Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator. * Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening. * Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1 suicide attempt \> 24 years of age. * Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening. * Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization. * Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ). * Participants with medical conditions that may interfere with the purpose or conduct of the study * Participant is pregnant, breastfeeding, or planning to become pregnant.

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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

    48 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Activmed Practices & Research, Llc - Methuen

    RECRUITING

    Methuen, Massachusetts, 01844, United States

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Advanced Quality Medical Research

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    San Diego, California, 92103, United States

  • Austin Clinical Trial Partners

    RECRUITING

    Austin, Texas, 78737, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Bioscience Research, LLC

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • Boehm-Peters PartGmbB - Praxis fur Psychiatrie, Psychotherapie, Neurologie

    RECRUITING

    Rosenheim, 83022, Germany

  • Boeson Research

    RECRUITING

    Provo, Utah, 84604, United States

  • California Neuroscience Research

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Center for Neurohealth

    RECRUITING

    La Jolla, California, 93037, United States

  • Centru De Evaluare Si Tratament A Toxicodependentenlor Pentru Tineri Sf. Stelian

    RECRUITING

    Bucharest, 011216, Romania

  • Charite - Universitatsmedizin Berline

    RECRUITING

    Berlin, 10117, Germany

  • Clinica Nutrimed Cercetare Sr

    RECRUITING

    Bucharest, 020744, Romania

  • Clinical Innovations Inc

    RECRUITING

    Bellflower, California, 90706, United States

  • Clinical Medical Research Sp. z o.o.

    RECRUITING

    Katowice, 40156, Poland

  • Dana Ignjatovićová, spol. s r.o

    RECRUITING

    Banská Bystrica, 97401, Slovakia

  • Delricht Research

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Emory University Brain Health Center

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Equipath Health and Research Tampa Bay, Llc

    RECRUITING

    Riverview, Florida, 33578, United States

  • Fieve Clinical Research, Inc.

    RECRUITING

    New York, New York, 10017, United States

  • Gulfcoast Clinical Research Center

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Harmonex Neuroscience Research

    TERMINATED

    Dothan, Alabama, 36303, United States

  • Hospital Universitari Vall D'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • IMA Clinical Research

    RECRUITING

    New York, New York, 10128, United States

  • In Vivo Sp. z.o.o.

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • Insight Clinical Trials

    RECRUITING

    Independence, Ohio, 44195, United States

  • Institute of Living

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Institutul Privat De Cercetari Melchisedec (ICPM) Pentru Boli Autoimune Ereditare si Rare - ICPM

    RECRUITING

    Craiova, 200157, Romania

  • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas

    RECRUITING

    Liptovský Mikuláš, 03123, Slovakia

  • Lumina Clinical Research Center

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Magnolia Clinical Research, Llc

    RECRUITING

    Cary, North Carolina, 27511, United States

  • Oulu Mentalcare Oy

    RECRUITING

    Oulu, 90100, Finland

  • Pacific Clinical Research Management Group

    COMPLETED

    Upland, California, 91786, United States

  • Pharmasite Research Inc.

    RECRUITING

    Baltimore, Maryland, 21208-6605, United States

  • Pillar Clinical Research

    RECRUITING

    Bentonville, Arkansas, 72712, United States

  • Praktyka Lekarska Malgorzata Wojtanowska-Bogacka

    RECRUITING

    Poznan, 60192, Poland

  • Princeton Medical Institute

    RECRUITING

    Princeton, New Jersey, 08540, United States

  • Psychiatric Care and Research Center

    RECRUITING

    O'Fallon, Missouri, 63368, United States

  • SanRo Clinical Research Group

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Sarkis Clinical Trials

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Smart Trials, LLC

    RECRUITING

    Jefferson, Louisiana, 70121, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Specjalistyczna Praktyka Lekarska, Filip Rybakowski

    RECRUITING

    Poznan, 60744, Poland

  • St. Charles Psychiatric Associates - Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Suomen Terveystalo Oy

    RECRUITING

    Helsinki, 00180, Finland

  • University of Alabama at Birmingham, Huntsville Regional Medical Campus

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Vitalix Clinical, Inc

    RECRUITING

    Worcester, Massachusetts, 01608, United States

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