Bipolar Disorder

Neurology
57
Pipeline Programs
22
Companies
50
Clinical Trials
1 recruiting
18
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
4
1
15
35
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
3100%
+ 57 programs with unclassified modality

On Market (18)

Approved therapies currently available

U
ARIPIPRAZOLEApproved
aripiprazole
Unknown Company
Atypical Antipsychotic [EPC]oral2015
U
ASENAPINE MALEATEApproved
asenapine
Unknown Company
Atypical Antipsychotic [EPC]sublingual2020
VP
FANAPTApproved
iloperidone
Vanda Pharmaceuticals
Atypical Antipsychotic [EPC]oral2009
Pfizer
GEODONApproved
ziprasidone hydrochloride
Pfizer
oral2006
U
ILOPERIDONEApproved
iloperidone
Unknown Company
oral
U
MEZOFYApproved
aripiprazole
Unknown Company
oral2025
U
OPIPZAApproved
aripiprazole
Unknown Company
Atypical Antipsychotic [EPC]oral2024
U
QUDEXY XRApproved
topiramate
Unknown Company
oral2014
U
ROPINIROLE HYDROCHLORIDEApproved
ropinirole
Unknown Company
oral2013
Takeda
ROZEREMApproved
ramelteon
Takeda
Melatonin Receptor Agonist [EPC]oral2005
U
SECUADOApproved
asenapine
Unknown Company
Atypical Antipsychotic [EPC]transdermal2019
U
SEROQUEL XRApproved
quetiapine fumarate
Unknown Company
oral2007
J&
TOPAMAXApproved
topiramate
Johnson & Johnson
oral1996
J&
TOPAMAX SPRINKLEApproved
topiramate
Johnson & Johnson
oral1998
U
TOPIRAMATEApproved
topiramate
Unknown Company
oral2024
U
VALPROATE SODIUMApproved
valproate sodium
Unknown Company
injection2021
U
ZYPREXAApproved
olanzapine
Unknown Company
Atypical Antipsychotic [EPC]oral1996
U
ZYPREXA ZYDISApproved
olanzapine
Unknown Company
Atypical Antipsychotic [EPC]oral2000

Competitive Landscape

20 companies ranked by most advanced pipeline stage

Alliance Pharmaceuticals
10 programs
1
1
3
Depakote-ERPhase 41 trial
LithiumPhase 41 trial
ropinirolePhase 41 trial
Quetiapine XRPhase 31 trial
TaurinePhase 11 trial
+5 more programs
Active Trials
NCT00226317Completed20Est. Feb 2008
NCT00879632Unknown200Est. Sep 2011
NCT02481895Completed100Est. Dec 2018
+7 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
9 programs
1
1
Quetiapine fumaratePhase 41 trial
Seroquel®, quetiapine fumaratePhase 31 trial
Depressive Symptoms in Acute Manic EpisodeN/A1 trial
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence StudyN/A1 trial
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in N/A1 trial
+4 more programs
Active Trials
NCT00690248Completed250Est. Dec 2008
NCT00927420Completed300Est. Oct 2009
NCT00660712Completed1,018Est. Mar 2009
+6 more trials
Pfizer
PfizerNEW YORK, NY
7 programs
4
1
AsenapinePhase 31 trial
GEODON(Geodon)Phase 35 trials
Ziprasidone oral capsulesPhase 34 trials
asenapinePhase 31 trial
Enhanced Clinical InterventionN/A
+2 more programs
Active Trials
NCT01282281Completed13Est. Sep 2013
NCT00584961Completed553Est. Feb 2009
NCT00143182Completed504Est. Jun 2006
+10 more trials
Abbott
AbbottABBOTT PARK, IL
5 programs
1
3
DepakotePhase 41 trial
divalproex ERPhase 43 trials
divalproex sodium extended releasePhase 41 trial
Divalproex Sodium ERPhase 32 trials
Enhanced Clinical InterventionN/A1 trial
Active Trials
NCT00211263Completed750Est. Feb 2007
NCT00194116Completed54Est. Feb 2008
NCT00203528Completed30Est. Feb 2007
+5 more trials
Sanofi
SanofiPARIS, France
5 programs
1
1
3
Valproate sodiumPhase 41 trial
Valproic acid, sodium saltPhase 41 trial
depakine chronoPhase 41 trial
SODIUM DIVALPROATEPhase 31 trial
AmisulpridePhase 21 trial
Active Trials
NCT00126009Completed120
NCT00271258Completed200Est. Jan 2007
NCT00264173Completed270Est. Sep 2006
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
4 programs
3
OlanzapinePhase 42 trials
Olanzapine/ZyprexaPhase 41 trial
olanzapinePhase 41 trial
White Matter in Pediatric Bipolar Disorder: A DTI StudyN/A
Active Trials
NCT00191997Completed180Est. Mar 2006
NCT00169702Completed100Est. Jul 2007
NCT00186017Completed50Est. Jun 2010
+1 more trials
Bristol Myers Squibb
3 programs
1
1
aripiprazolePhase 4Small Molecule5 trials
Low dose Adjunctive AripiprazolePhase 3Small Molecule1 trial
Enhanced Clinical InterventionN/A
Active Trials
NCT01520350Terminated2Est. Jun 2013
NCT01386086Completed10Est. Nov 2013
NCT01227668Completed215Est. Jun 2012
+3 more trials
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
3 programs
1
2
1
Risperidone, oral tabletsPhase 32 trials
TopiramatePhase 31 trial
TOPAMAX(topiramate)Phase 11 trial
Active Trials
NCT00986128Completed32Est. Oct 2002
NCT00249236Completed291Est. Dec 2001
NCT00257075Completed267Est. May 2002
+1 more trials
Takeda
TakedaTOKYO, Japan
1 program
1
1
RamelteonPhase 31 trial
Active Trials
NCT01677182Terminated535Est. Sep 2014
Novartis
NovartisBASEL, Switzerland
1 program
1
iloperidonePhase 45 trials
Active Trials
NCT01917318Terminated1Est. Feb 2014
NCT01920802Completed31Est. Sep 2014
NCT01929889Terminated19Est. Oct 2014
+2 more trials
VP
Vanda PharmaceuticalsWASHINGTON, DC
1 program
1
iloperidonePhase 4
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
1 program
1
ropinirolePhase 41 trial
Active Trials
NCT00335205Unknown60
Gedeon Richter
Gedeon RichterHungary - Budapest
2 programs
1
1
CariprazinePhase 31 trial
CariprazinePhase 21 trial
Active Trials
NCT00488618Completed238Est. Jul 2008
NCT01058096Completed323Est. Jul 2011
Xenon Pharmaceuticals
1 program
1
AzetukalnerPhase 31 trial
Active Trials
NCT07172516Recruiting400Est. Aug 2028
Astellas
AstellasChina - Shenyang
1 program
1
FK949EPhase 31 trial
Active Trials
NCT01737268Completed20Est. Jun 2016
Biohaven
BiohavenNEW HAVEN, CT
2 programs
1
1
BHV-7000Phase 2/31 trial
BHV-7000Phase 21 trial
Active Trials
NCT06423794TerminatedEst. Apr 2025
NCT06419582CompletedEst. Jan 2025
Neuronetics
NeuroneticsMALVERN, PA
1 program
1
Repetitive Transcranial Magnetic StimulationPhase 21 trial
Active Trials
NCT00447096Withdrawn0Est. Feb 2010
AB
AP BiosciencesTaiwan - Taipei
1 program
EDIT-B testN/A1 trial
Active Trials
NCT06507787RecruitingEst. May 2027
Providence Therapeutics
1 program
Integrated Treatment Adherence Program for VeteransN/A1 trial
Active Trials
NCT04127604CompletedEst. Sep 2025
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
≥ 1 potential risk factor for BDN/A1 trial
Active Trials
NCT02456545CompletedEst. Oct 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Alliance PharmaceuticalsLithium
Novartisiloperidone
Novartisiloperidone
Novartisiloperidone
Novartisiloperidone
Bristol Myers Squibbaripiprazole
Novartisiloperidone
Bristol Myers Squibbaripiprazole
Bristol Myers Squibbaripiprazole
Bristol Myers Squibbaripiprazole
Sanofidepakine chrono
Abbottdivalproex ER
AbbottDepakote
Abbottdivalproex ER
Bristol Myers Squibbaripiprazole

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 4,370 patients across 50 trials

NCT02909504Alliance PharmaceuticalsLithium

Gao NARASD Lithium Study

Start: Sep 2016Est. completion: Nov 201824 patients
Phase 4Terminated
NCT01920802Novartisiloperidone

Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo

Start: Nov 2012Est. completion: Sep 201431 patients
Phase 4Completed
NCT01929889Novartisiloperidone

Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

Start: Apr 2012Est. completion: Oct 201419 patients
Phase 4Terminated
NCT02413918Novartisiloperidone

Iloperidone in Mixed States of Bipolar Disorder

Start: Apr 2012Est. completion: Apr 201541 patients
Phase 4Completed
NCT01464229Novartisiloperidone

Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability

Start: Apr 2012Est. completion: Dec 201420 patients
Phase 4Completed
NCT01227668Bristol Myers Squibbaripiprazole

Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

Start: Mar 2011Est. completion: Jun 2012215 patients
Phase 4Completed
NCT01207414Novartisiloperidone

Switching to Iloperidone From Other Antipsychotics in Schizophrenia

Start: Aug 2010Est. completion: Jan 2012501 patients
Phase 4Completed
NCT01411930Bristol Myers Squibbaripiprazole

Acute Impact of Intramuscular (IM) Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics

Start: Mar 2009Est. completion: Aug 201115 patients
Phase 4Completed
NCT00508157Bristol Myers Squibbaripiprazole

A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Start: Nov 2007Est. completion: Mar 2009125 patients
Phase 4Terminated
NCT01052389Bristol Myers Squibbaripiprazole

Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia

Start: Jul 2007Est. completion: Jun 2013300 patients
Phase 4Completed
NCT00477373Sanofidepakine chrono

Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Start: Dec 200670 patients
Phase 4Completed
NCT00397020Abbottdivalproex ER

Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes

Start: Dec 2006Est. completion: Dec 200830 patients
Phase 4Completed
NCT01075126AbbottDepakote

Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder

Start: Dec 2006Est. completion: Dec 200650 patients
Phase 4Withdrawn
NCT00375557Abbottdivalproex ER

Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients

Start: Oct 2006Est. completion: Sep 20070
Phase 4Withdrawn
NCT00608543Bristol Myers Squibbaripiprazole

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

Start: Oct 2005Est. completion: Jan 200917 patients
Phase 4Completed
NCT00314821Alliance Pharmaceuticalsropinirole

Ropinirole in the Treatment of Bipolar Depression

Start: Sep 2005Est. completion: Mar 200840 patients
Phase 4Completed
NCT00139074AstraZenecaQuetiapine fumarate

Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Start: Jul 2005Est. completion: Jun 200617 patients
Phase 4Terminated
NCT00186017Eli Lilly and CompanyOlanzapine/Zyprexa

Short Term Rescue Study of Olanzapine

Start: Jul 2005Est. completion: Jun 201050 patients
Phase 4Completed
NCT00438386Bristol Myers Squibbaripiprazole

Aripiprazole for the Treatment of Refractory Anxiety

Start: Apr 2005Est. completion: Jun 2007
Phase 4Completed
NCT00221962Bristol Myers Squibbaripiprazole

Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)

Start: Apr 2005Est. completion: Apr 200723 patients
Phase 4Completed
NCT00208169Bristol Myers Squibbaripiprazole

Abilify Therapy for Reducing Comorbid Substance Abuse

Start: Mar 2005Est. completion: Jun 200730 patients
Phase 4Completed
NCT00220636Bristol Myers Squibbaripiprazole

Abilify as an Adjunctive Treatment for Refractory Depression

Start: Mar 2005Est. completion: Jan 200815 patients
Phase 4Completed
NCT00205660Bristol Myers Squibbaripiprazole

Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole

Start: Feb 2005Est. completion: Aug 200951 patients
Phase 4Completed
NCT00431522SanofiValproic acid, sodium salt

Valproic Acid Sodium Salt in Bipolar Disorder

Start: Dec 2004Est. completion: Oct 200658 patients
Phase 4Completed
NCT00250705Bristol Myers Squibbaripiprazole

Trial of Aripiprazole in the Treatment of CD in Adolescents

Start: Nov 2004Est. completion: Mar 200912 patients
Phase 4Completed
NCT00222833Bristol Myers Squibbaripiprazole

The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia

Start: Oct 2004Est. completion: Dec 200530 patients
Phase 4Completed
NCT00191997Eli Lilly and CompanyOlanzapine

Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed Episode

Start: Oct 2004Est. completion: Mar 2006180 patients
Phase 4Completed
NCT00190892Eli Lilly and Companyolanzapine

Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

Start: Sep 2004Est. completion: Jun 2006120 patients
Phase 4Completed
NCT00223496Bristol Myers Squibbaripiprazole

12- Week Open Label Treatment of Refractory Bipolar Depression

Start: Sep 2004Est. completion: Sep 200932 patients
Phase 4Completed
NCT00194038Bristol Myers Squibbaripiprazole

Aripiprazole in Late Life Bipolar Disorder

Start: Apr 2004Est. completion: Jun 200620 patients
Phase 4Completed
NCT00208195Abbottdivalproex ER

Depakote ER Therapy for Mania Comorbid With Substance Abuse

Start: Mar 2004Est. completion: Nov 200720 patients
Phase 4Completed
NCT00224822Bristol Myers Squibbaripiprazole

The Effects of Aripiprazole on Patients With Metabolic Syndrome

Start: Mar 2004Est. completion: Mar 200727 patients
Phase 4Completed
NCT00264173SanofiValproate sodium

VALID : VAlproate Versus LIthium in Bipolar Disorders

Start: Feb 2004Est. completion: Sep 2006270 patients
Phase 4Completed
NCT00203528AbbottDivalproex Sodium ER

Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder

Start: Jan 2004Est. completion: Feb 200730 patients
Phase 4Completed
NCT00181727Abbottdivalproex sodium extended release

Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

Start: Jan 2004Est. completion: Nov 200614 patients
Phase 4Completed
NCT00226343Alliance PharmaceuticalsDepakote-ER

Depakote-ER for Depressive and Bipolar Depression

Start: Aug 2003Est. completion: Aug 200625 patients
Phase 4Completed
NCT00335205Jerusalem Pharmaceuticalsropinirole

A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.

Start: Apr 200360 patients
Phase 4Unknown
NCT00181779Bristol Myers Squibbaripiprazole

Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

Start: Feb 2003Est. completion: Dec 200620 patients
Phase 4Completed
NCT00208208PfizerGeodon

Geodon (Ziprasidone) for Posttraumatic Stress Disorder

Start: Dec 2002Est. completion: Apr 200580 patients
Phase 4Completed
NCT00181922PfizerGeodon

Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

Start: Mar 2002Est. completion: Dec 200420 patients
Phase 4Completed
NCT07172516Xenon PharmaceuticalsAzetukalner

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

Start: Aug 2025Est. completion: Aug 2028400 patients
Phase 3Recruiting
NCT01737268AstellasFK949E

Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Start: Oct 2012Est. completion: Jun 201620 patients
Phase 3Completed
NCT01677182TakedaRamelteon

Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

Start: Aug 2012Est. completion: Sep 2014535 patients
Phase 3Terminated
NCT01520350Bristol Myers SquibbLow dose Adjunctive Aripiprazole

Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

Start: Feb 2012Est. completion: Jun 20132 patients
Phase 3Terminated
NCT01386086Bristol Myers Squibbaripiprazole

Aripiprazole and Resistant Postpartum Depression

Start: Jun 2011Est. completion: Nov 201310 patients
Phase 3Completed
NCT01124877PfizerZiprasidone oral capsules

Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Start: Jul 2010Est. completion: Oct 20110
Phase 3Withdrawn
NCT01058096Gedeon RichterCariprazine

Safety and Efficacy of Cariprazine for Mania

Start: Feb 2010Est. completion: Jul 2011323 patients
Phase 3Completed
NCT00870727Bristol Myers Squibbaripiprazole

Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

Start: Feb 2009Est. completion: May 201533 patients
Phase 3Completed
NCT00683852Bristol Myers Squibbaripiprazole

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy

Start: Sep 2008Est. completion: Sep 2009225 patients
Phase 3Completed
NCT00671853Alliance PharmaceuticalsQuetiapine XR

Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)

Start: Apr 2008Est. completion: Mar 2011120 patients
Phase 3Completed

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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

15 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 4,370 patients
22 companies competing in this space

Related Indications

Multiple Sclerosis(274)Schizophrenia(255)Epilepsy(242)Parkinson Disease(171)Alzheimer's Disease(165)Parkinson's Disease(160)Alzheimer Disease(117)Stroke(102)Relapsing-Remitting Multiple Sclerosis(83)Depression(82)