Bipolar Depression

Neurology
3
Pipeline Programs
7
Companies
9
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Xenon Pharmaceuticals
1 program
1
AzetukalnerPhase 31 trial
Active Trials
NCT07217860Enrolling By Invitation400Est. Aug 2029
Astellas
AstellasChina - Shenyang
1 program
1
FK949EPhase 31 trial
Active Trials
NCT02362412Completed22Est. Feb 2016
Gedeon Richter
Gedeon RichterHungary - Budapest
1 program
1
cariprazinePhase 21 trial
Active Trials
NCT00852202Completed234Est. Jun 2010
BrainsWay
BrainsWayJerusalem, Israel
3 programs
Deep Brain Transcranial Magnetic StimulationN/A1 trial
Deep TMS TreatmentN/A1 trial
H-Coil deep TMSN/A1 trial
Active Trials
NCT01962350CompletedEst. Nov 2016
NCT01566591UnknownEst. Dec 2021
NCT00657735UnknownEst. Jan 2013
Alliance Pharmaceuticals
1 program
CoEnzyme Q10N/A1 trial
Active Trials
NCT00720369Completed42Est. Mar 2010
Magnus Medical
Magnus MedicalCA - Burlingame
1 program
Magnus Transcranial Magnetic Neuromodulation SystemN/A1 trial
Active Trials
NCT05375214CompletedEst. Nov 2023
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Treatment Clinical Practice in Bipolar Depression in SpainN/A1 trial
Active Trials
NCT00757328Completed378Est. Dec 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Xenon PharmaceuticalsAzetukalner
AstellasFK949E
Gedeon Richtercariprazine
Magnus MedicalMagnus Transcranial Magnetic Neuromodulation System
BrainsWayDeep Brain Transcranial Magnetic Stimulation
BrainsWayDeep TMS Treatment
BrainsWayH-Coil deep TMS
Alliance PharmaceuticalsCoEnzyme Q10
AstraZenecaTreatment Clinical Practice in Bipolar Depression in Spain

Clinical Trials (9)

Total enrollment: 1,076 patients across 9 trials

NCT07217860Xenon PharmaceuticalsAzetukalner

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

Start: Oct 2025Est. completion: Aug 2029400 patients
Phase 3Enrolling By Invitation
NCT02362412AstellasFK949E

Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes

Start: Feb 2015Est. completion: Feb 201622 patients
Phase 3Completed
NCT00852202Gedeon Richtercariprazine

Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Start: Jun 2009Est. completion: Jun 2010234 patients
Phase 2Completed
NCT05375214Magnus MedicalMagnus Transcranial Magnetic Neuromodulation System

iTBS in Bipolar I Depression

Start: Mar 2023Est. completion: Nov 2023
N/ACompleted
NCT01962350BrainsWayDeep Brain Transcranial Magnetic Stimulation

Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS: Clinical-Cognitive and Safety Evaluation

Start: Feb 2014Est. completion: Nov 2016
N/ACompleted
NCT01566591BrainsWayDeep TMS Treatment

Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

Start: May 2012Est. completion: Dec 2021
N/AUnknown
NCT00657735BrainsWayH-Coil deep TMS

Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression

Start: Jan 2009Est. completion: Jan 2013
N/AUnknown
NCT00720369Alliance PharmaceuticalsCoEnzyme Q10

CoQ10 in Geriatric Bipolar Depression

Start: Jul 2008Est. completion: Mar 201042 patients
N/ACompleted
NCT00757328AstraZenecaTreatment Clinical Practice in Bipolar Depression in Spain

Treatment Clinical Practice in Bipolar Depression in Spain

Start: Jul 2008Est. completion: Dec 2008378 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
7 companies competing in this space

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