Major Depressive DisorderPhase 3X-NOVA-OLENCT06922110

An Open-Label Study of Azetukalner in Major Depressive Disorder

A Phase 3 study testing Azetukalner in people with Major Depressive Disorder, run by Xenon Pharmaceuticals Inc. at 71 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Azetukalner
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 460 participants
Where: 71 sitesin 3 countries
Study dates: 18 Mar 2025to Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

71 sites in 3 countries.

Country

City, postcode or hospital

71 sites in 3 countries

United States69 sites

Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18103
Advanced Discovery Research, Llc
Atlanta, Georgia, 30318
Synexus - Atlanta
Atlanta, Georgia, 30328
DelRicht Research
Atlanta, Georgia, 30329
Austin Clinical Trial Partners
Austin, Texas, 78737
Pharmasite Research Inc.
Baltimore, Maryland, 21208-6605
Cenexel Cit - Bellflower
Bellflower, California, 90706
Adams Clinical - Boston
Boston, Massachusetts, 02116
Boston Clinical Trials Llc
Boston, Massachusetts, 02131
Integrative Clinical Trials, Llc
Brooklyn, New York, 11229
Sanro Clinical Research Group, Llc
Bryant, Arkansas, 72022
Magnolia Clinical Research
Cary, North Carolina, 27511
New Hope Clinical Research
Charlotte, North Carolina, 28211
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002
IMA Clinical Research
Chicago, Illinois, 60634
Pharmasouth Research
Coral Gables, Florida, 33146
Cns Clinical Research - Coral Springs
Coral Springs, Florida, 33067
Ct Clinical Research Associates
Cromwell, Connecticut, 06416
Cenexel Iresearch - Atlanta
Decatur, Georgia, 30030
Core Clinical Research
Everett, Washington, 98201
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Sarkis Clinical Trials
Gainesville, Florida, 32607
Institute of Living - Clinical Trials Unit
Hartford, Connecticut, 06106
Neoclinical Research
Hialeah, Florida, 33016
Insight Clinical Trials Llc
Independence, Ohio, 44131
Irvine Clinical Research
Irvine, California, 92614
Clinical Neuroscience Solutions Llc.
Jacksonville, Florida, 32256
Accel Research Sites - Lakeland
Lakeland, Florida, 33803
Accel Research Sites - St. Petersburg-Largo
Largo, Florida, 33777
Ima Clinical Research - Las Vegas
Las Vegas, Nevada, 89102
Redbird Research
Las Vegas, Nevada, 89119
Woodland International Research Group
Little Rock, Arkansas, 72211
Calneuro Research Group, Inc.
Los Angeles, California, 90025
Psych Atlanta, Pc
Marietta, Georgia, 30060
Clinical Neuroscience Solutions, LLC
Memphis, Tennessee, 38119
Bioscience Research Llc.
Mount Kisco, New York, 10549
Fieve Clinical Research (Fcr), Inc.
New York, New York, 10017-1921
Ima Clinical Research - Nyc Uptown
New York, New York, 10128
Harmony Clinical Research Inc
North Miami Beach, Florida, 33162
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Excell Research Inc.
Oceanside, California, 92056
Pahl Pharmaceutical Professionals Llc
Oklahoma City, Oklahoma, 73112
Sooner Clinical Research
Oklahoma City, Oklahoma, 73116
Atp Clinical Research
Orange, California, 92866
Nrc Research Institute
Orange, California, 92868
Advanced Quality Medical Research, LLC
Orland Park, Illinois, 60462
Clinical Neuroscience Solutions Llc
Orlando, Florida, 32801
Combined Research Orlando Phase I-Iv
Orlando, Florida, 32807
Panhandle Research and Medical Clinic
Pensacola, Florida, 32502
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Ima Clinical Research - Phoenix
Phoenix, Arizona, 85012
Delricht Research - Plano
Plano, Texas, 75024
Global Medical Institutes - Princeton Medical Institute
Princeton, New Jersey, 08540
Boeson Research Pvu
Provo, Utah, 84604
Equipath Health and Research Tampa Bay, Llc
Riverview, Florida, 33578
Woodland Research Northwest
Rogers, Arkansas, 72758
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Artemis Institute For Clinical Research - San Diego
San Diego, California, 92123
Cenexel Iresearch - Savannah
Savannah, Georgia, 31405
Cenexel Cnr - Sherman Oaks
Sherman Oaks, California, 91403-2131
Elixia MA, LLC
Springfield, Massachusetts, 01103
Richmond Behavioral Associates
Staten Island, New York, 10314
Bio Behavioral Health
Toms River, New Jersey, 08755
Cenexel Cns - Torrance
Torrance, California, 90501
Pacific Clinical Research Management
Upland, California, 91786
Sunwise Clinical Research
Walnut Creek, California, 94596
Adams Clinical - Watertown
Watertown, Massachusetts, 02472
Grayline Research Center
Wichita Falls, Texas, 76309
Vitalix Clinical - Worcester
Worcester, Massachusetts, 01608

Other trials in United States

Finland1 site

Oulu Mentalcare Oy
Oulu, 90100

Other trials in Finland

Poland1 site

Praktyka Lekarska Malgorzata Wojtanowska-Bogacka - Centrum Badań Klinicznych
Poznan, 60192

Other trials in Poland

About this study

Official title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: Azetukalner
Keywords: Depression, Antidepressant, XEN1101, Azetukalner
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzetukalnerDrug
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

Study groups in NCT06922110
Study group	Role	What they receive
Azetukalner 20 mg	Experimental	Not described Receives: Drug: Azetukalner

What is being measured

The primary outcome is the main question the study is designed to answer.

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Measured: From the start of treatment in the open-label extension study through 8 weeks after the last dose

Secondary outcomes (5)

Change from baseline in the Hamilton Depression Rating Scale, 17-Item (HAMD-17) total score over time
Measured: From baseline through the active extension treatment (Week 52)
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Measured: From baseline through the active extension treatment (Week 52)
Change in the Clinical Global Impression of Severity (CGI-S) score over time
Measured: From baseline through the active extension treatment (Week 52)
Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores over time
Measured: From baseline through the active extension treatment (Week 52)
Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores over time
Measured: From baseline through the active extension treatment (Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 2025Mar 2027

First posted10 Apr 2025
Study start18 Mar 2025
Primary completionJan 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 460 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06922110
Sponsor's protocol ID: XPF-010-D303
Acronym: X-NOVA-OLE
Status last verified: Oct 2026
First submitted: 20 Mar 2025
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
ClinicalTrials.gov ID: NCT06922110
Acronym / sponsor ID: X-NOVA-OLE / XPF-010-D303
Conditions: Major Depressive Disorder
Keywords: Depression, Antidepressant, XEN1101, Azetukalner
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 460 participants (estimated)
Lead sponsor: Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 18 Mar 2025 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 10 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Azetukalner 20 mg	Experimental	Drug: Azetukalner

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzetukalnerAzetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.	Drug	Azetukalner 20 mg

Primary outcome

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose

5 secondary outcomes

Change from baseline in the Hamilton Depression Rating Scale, 17-Item (HAMD-17) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change in the Clinical Global Impression of Severity (CGI-S) score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores over time
Time frame: From baseline through the active extension treatment (Week 52)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
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Not yet recruiting
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Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

71 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azetukalner in people with Major Depressive Disorder, run by Xenon Pharmaceuticals Inc. at 71 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Finland, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest (time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06922110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.