Which bipolar depression drugs are in Phase 3?

Phase 3 (or later) programs for bipolar depression include Lumateperone (ITI-007) and Azetukalner (XEN1101).

What are the next bipolar depression trial readouts?

Upcoming catalysts include LB-102 (N-methylamisulpride) (1Q 2028) and Azetukalner (XEN1101) (2028).

How many clinical trials are recruiting for bipolar depression?

38 drug-interventional bipolar depression trials are currently recruiting participants, out of 339 registered interventional trials.

Mood Disorders

Bipolar depression drug pipeline

MeSH D001714
Subtype of Bipolar disorder

6 compounds from 6 companies are in active clinical development for bipolar depression, including 2 at Phase 3 or beyond.

6Compounds

6Companies

2Phase 3+

2Upcoming readouts

39Trials recruiting

Approved 1
Phase 3 1
Phase 2 3
Discontinued 1

Mechanisms: Small molecule (5) · Psychedelic (1)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

1Q 2028AnticipatedLB-102 (N-methylamisulpride)Topline dataNCT07494305
Phase 2 ILLUMINATE-1 topline (MADRS-10 change at Week 6) in bipolar I depression anticipated in 1Q 2028. ↗
2028AnticipatedAzetukalner (XEN1101)Topline dataNCT07172516
X-CEED Phase 3 topline in bipolar I/II depression (MADRS at Week 6) anticipated ↗
2026-06-04ReportedElunetirom (ABX-002)Topline datametNCT06869187
AMPLIFY-BD met its primary endpoint: HAMD-17 -16.8 at Week 6 (p<0.001), 75% response, 50% remission in adjunctive bipolar depression. ↗
2025-01-10ReportedMebufotenin (inhaled 5-MeO-DMT, GH001)Topline datametNCT05839509
GH001 met primary endpoint in Phase 2a bipolar II depression POC: -16.8-point (51.9%) MADRS reduction at Day 8 (p=0.0099), 33% Day-8 remission (n=6) ↗
2023-02-13ReportedLumateperone (ITI-007)Full resultsmetNCT02600507
Study 402 positive (42 mg): lumateperone adjunctive to lithium/valproate met the MADRS Week-6 primary in bipolar depression (LSMD -2.4, p=0.02). ↗
2021-12-20ReportedLumateperone (ITI-007)Regulatorymet
FDA approved Caplyta (lumateperone) for bipolar I and II depression in adults, as monotherapy and as adjunctive therapy with lithium or valproate. ↗

See the full catalyst calendar →

Compounds in development (6)

Compound	Company	Phase	Status	Mechanism
Lumateperone (ITI-007)	Johnson & Johnson	Approved	Approved	5-HT2A Antagonist
Azetukalner (XEN1101)	Xenon Pharmaceuticals Inc.	Phase 3	Recruiting	Kv7.2 Activator
ALTO-100 (amdiglurax)	Alto Neuroscience, Inc.	Phase 2	Recruiting	TLX Agonist
Elunetirom (ABX-002)Fast Track	Autobahn Therapeutics, Inc.	Phase 2	Active	TRbeta Agonist
LB-102 (N-methylamisulpride)	LB Pharmaceuticals Inc.	Phase 2	Recruiting	D2 Antagonist
Mebufotenin (inhaled 5-MeO-DMT, GH001)	GH Research PLC	Discontinued	Discontinued	5-HT2A Agonist

Trials recruiting now (38)

38 drug-interventional bipolar depression trials recruiting now, of 339 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Vortioxetine, Cariprazine (Augmentation Phase)
Mayo Clinicn=120United States · 1 siteStarted Feb 2026NCT07266545
Phase 4A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Valbenazine
Neurocrine Biosciences, Inc.n=50United States · 22 sitesStarted Aug 2025NCT07105111
Phase 4Lithium for Prevention of Cognitive Declining in Mood Illnesses
Trace lithium dose plus treatment as usual, Placebo pill plus treatment as usual
University of Chilen=250Chile · 2 sitesStarted Nov 2024NCT06662526
Phase 4Non-invasive BCI and Application Verification for Depressed People
SSRI
Shanghai Mental Health Centern=400China · 1 siteStarted Jul 2023NCT06417437
Phase 4Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Lithium, Cariprazine
Aalborg University Hospitaln=122Denmark · 1 siteStarted Dec 2022NCT05913947
Phase 3Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Pramipexole
Daniel Lindqvistn=126Sweden · 1 siteStarted Sep 2026NCT07664852
Phase 3Cognitive Strategies in Early Psychosis 2
Modafinil, D-serine solution, Placebo
University of Minnesotan=24Started Jul 2026NCT07263022
Phase 3Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
psilocybin (25 mg), psilocybin 1mg micro-dose
Lakshmi N Yathamn=90Canada · 3 sitesStarted May 2026NCT06943573
Phase 3Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Lacosamide, Placebo
University of Sao Paulon=40Brazil · 1 siteStarted Jan 2026NCT07412132
Phase 3A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)
Azetukalner, Placebo
Xenon Pharmaceuticals Inc.n=400United States · 28 sitesStarted Aug 2025Tracked: Azetukalner (XEN1101)NCT07172516
Phase 3Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
Clozapine, Esketamine Nasal Product, Escitalopram, Sertraline, Venlafaxine, Lithium, Valproate acid, Quetiapine, Second-line Antidepressants, Second-line Antipsychotics, Ketamine Hydrochloride, Esketamine hydrochloride, Bupropion
Dr. Inge Wintern=1,254Israel · 1 siteStarted Apr 2025NCT05603104
Phase 3The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Escitalopram, Sertraline, Venlafaxine, Lithium, Valproate acid, Quetiapine, Bupropion
Dr. Inge Wintern=418Austria, Germany +4 · 13 sitesStarted Feb 2025NCT05973786

Showing the 12 most advanced of 38 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for bipolar depression?: 6 compounds from 6 companies are in active clinical development for bipolar depression, including 2 at Phase 3 or beyond.
Which bipolar depression drugs are in Phase 3?: Phase 3 (or later) programs for bipolar depression include Lumateperone (ITI-007) and Azetukalner (XEN1101).
What are the next bipolar depression trial readouts?: Upcoming catalysts include LB-102 (N-methylamisulpride) (1Q 2028) and Azetukalner (XEN1101) (2028).
How many clinical trials are recruiting for bipolar depression?: 38 drug-interventional bipolar depression trials are currently recruiting participants, out of 339 registered interventional trials.