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Azetukalner

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Xenon Pharmaceuticals Inc.|Last Updated: Jun 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC

Total Trials3

Total Enrollment1,360

FDA Designations

No designations recorded

Clinical trial landscape

Azetukalner · 5 trials · 5 indications

Phase 3 5

Indication

NCT07217860An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)Bipolar Depression

ENROLLING BY_INVITATION400 Analytics

NCT07172516A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)Bipolar Disorder

RECRUITING400 Analytics

NCT07076407A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)Major Depressive Disorder

RECRUITING450 Analytics

NCT06922110An Open-Label Study of Azetukalner in Major Depressive DisorderMajor Depressive Disorder

ENROLLING BY_INVITATION460 Analytics

NCT06775379A Randomized Study of Azetukalner Versus Placebo in Major Depressive DisorderMajor Depressive Disorder

RECRUITING450 Analytics

PHASE3ENROLLING BY_INVITATION

An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

Bipolar Depression

NCT07217860400

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PHASE3RECRUITING

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Bipolar Disorder

NCT07172516400

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PHASE3RECRUITING

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

Major Depressive Disorder

NCT07076407450

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PHASE3ENROLLING BY_INVITATION

An Open-Label Study of Azetukalner in Major Depressive Disorder

Major Depressive Disorder

NCT06922110460

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PHASE3RECRUITING

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Major Depressive Disorder

NCT06775379450

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Study Endpoints

Primary Endpoints

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest

From the start of treatment in the open-label extension study through 8 weeks after the last dose

Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.

Baseline to Week 6

Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

Baseline to Week 6

The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.

Secondary Endpoints

Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time

From baseline through the active extension treatment (Week 52)

Change in Clinical Global Impression of Severity (CGI-S) score over time

From baseline through the active extension treatment (Week 52)

Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time

From baseline through the active extension treatment (Week 52)

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Azetukalner 20 mg	EXPERIMENTAL	-
Azetukalner	EXPERIMENTAL	Azetukalner 20 mg
Placebo	PLACEBO_COMPARATOR	Placebo

Interventions

Name	Type	Description
Azetukalner	DRUG	Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Placebo	DRUG	Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

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Eligibility Criteria

Age Range18 Years to 75 Years

SexALL

Healthy VolunteersNo

Study Sites15

Inclusion Criteria: * Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression. * Participant provides written informed consent to participate in the study, is able to understand the procedures and study req...

Countries:United StatesFinlandPolandRomaniaSlovakiaSpain

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Competitive Landscape -Major Depressive Disorder 87 trials

Top 20 of 32 competitors

Company	Ticker	Trials	Lead Phase	Drugs
COMPASS Pathways Plc Sponsored ADR	CMPS	5	PHASE3	Psilocybin
Neurocrine Biosciences, Inc.	NBIX	5	PHASE3	NBI-1065845
Johnson & Johnson	JNJ	3	PHASE3	Esketamine, Midazolam
AbbVie, Inc.	ABBV	2	PHASE3	Cariprazine
Xenon Pharmaceuticals Inc.	XENE	3	PHASE3	Azetukalner
Axsome Therapeutics, Inc.	AXSM	2	PHASE3	Solriamfetol
Definium Therapeutics, Inc.	DFTX	2	PHASE3	DT120
Eli Lilly and Company	LLY	1	PHASE3	Brenipatide
Takeda Pharmaceutical Co. Ltd. Sponsored ADR	TAK	1	PHASE3	Vortioxetine
Cybin, Inc.	HELP	3	PHASE3	CYB003
Vanda Pharmaceuticals Inc.	VNDA	1	PHASE3	Milsaperidone
Neumora Therapeutics, Inc.	NMRA	1	PHASE3	NMRA-335140
AtaiBeckley Inc.	ATAI	3	PHASE2	VLS-01-203 BU
ACADIA Pharmaceuticals Inc.	ACAD	1	PHASE2	ACP-211
Supernus Pharmaceuticals, Inc.	SUPN	1	PHASE2	SPN-821
Alto Neuroscience, Inc.	ANRO	1	PHASE2	ALTO-300
Harvard Bioscience, Inc.	HBIO	3	PHASE3	Antidepressant medication
Seaport Therapeutics, Inc.	SPTX	2	PHASE2	SPT-300
Sunshine Biopharma Incorporated	SBFM	1	PHASE2	Mitizodone
Masimo Corporation	MASI	1	PHASE1	Diprivan , Astra-Zeneca

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