Bipolar I Disorder

Neurology
18
Pipeline Programs
9
Companies
13
Clinical Trials
6
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
0
5
7
Early DiscoveryClinical DevelopmentMarket

On Market (6)

Approved therapies currently available

VP
FANAPTApproved
iloperidone
Vanda Pharmaceuticals
Atypical Antipsychotic [EPC]oral2009
U
ILOPERIDONEApproved
iloperidone
Unknown Company
Atypical Antipsychotic [EPC]oral2016
U
OLANZAPINEApproved
olanzapine
Unknown Company
Atypical Antipsychotic [EPC]oral2014
AbbVie
VRAYLARApproved
cariprazine
AbbVie
Atypical Antipsychotic [EPC]oral2015
U
ZYPREXAApproved
olanzapine
Unknown Company
Atypical Antipsychotic [EPC]intramuscular2004
U
ZYPREXA ZYDISApproved
olanzapine
Unknown Company
Atypical Antipsychotic [EPC]oral2000

Competitive Landscape

8 companies ranked by most advanced pipeline stage

VP
Vanda PharmaceuticalsWASHINGTON, DC
2 programs
1
1
1
IloperidonePhase 31 trial
IloperidonePhase 11 trial
Active Trials
NCT04127058Completed12Est. Nov 2019
NCT04819776Completed417Est. Aug 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
1
CariprazinePhase 31 trial
Active Trials
NCT03573297Completed901Est. Sep 2022
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
OlanzapinePhase 41 trial
Active Trials
NCT00982020Completed203Est. May 2013
Alliance Pharmaceuticals
2 programs
1
SensorilPhase 31 trial
L-carnosineN/A1 trial
Active Trials
NCT00177463Completed47Est. Dec 2007
NCT00761761Completed60Est. Mar 2011
Alkermes
AlkermesDUBLIN 4, Ireland
2 programs
1
1
OLZ/SAMPhase 31 trial
OLZ/SAMPhase 11 trial
Active Trials
NCT04987658CompletedEst. Aug 2023
NCT04987229Enrolling By InvitationEst. Sep 2027
Gedeon Richter
Gedeon RichterHungary - Budapest
1 program
1
CariprazinePhase 31 trial
Active Trials
NCT01059539Completed403Est. Feb 2012
Bial
BialPortugal - Coronado
3 programs
3
BIA 2-093 1800 mg once daily [Group 1Phase 21 trial
Eslicarbazepine AcetatePhase 21 trial
Eslicarbazepine acetate 1800 mgPhase 21 trial
Active Trials
NCT01825837CompletedEst. Jun 2007
NCT01822678CompletedEst. Nov 2006
NCT01824602TerminatedEst. Nov 2006
Pfizer
PfizerNEW YORK, NY
1 program
1
BifeprunoxPhase 21 trial
Active Trials
NCT00141505CompletedEst. Dec 2006

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Eli Lilly and CompanyOlanzapine
AlkermesOLZ/SAM
Vanda PharmaceuticalsIloperidone
AbbVieCariprazine
Gedeon RichterCariprazine
Alliance PharmaceuticalsSensoril
BialBIA 2-093 1800 mg once daily [Group 1
BialEslicarbazepine acetate 1800 mg
BialEslicarbazepine Acetate
PfizerBifeprunox
AlkermesOLZ/SAM
Vanda PharmaceuticalsIloperidone
Alliance PharmaceuticalsL-carnosine

Clinical Trials (13)

Total enrollment: 2,043 patients across 13 trials

NCT00982020Eli Lilly and CompanyOlanzapine

Study in Adolescents With Schizophrenia or Bipolar Disorder

Start: Sep 2009Est. completion: May 2013203 patients
Phase 4Completed
NCT04987229AlkermesOLZ/SAM

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Start: Oct 2021Est. completion: Sep 2027
Phase 3Enrolling By Invitation
NCT04819776Vanda PharmaceuticalsIloperidone

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Start: Mar 2021Est. completion: Aug 2023417 patients
Phase 3Completed
NCT03573297AbbVieCariprazine

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Start: Jun 2018Est. completion: Sep 2022901 patients
Phase 3Completed
NCT01059539Gedeon RichterCariprazine

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Start: Feb 2010Est. completion: Feb 2012403 patients
Phase 3Completed
NCT00761761Alliance PharmaceuticalsSensoril

Sensoril(Ashwaganhda)for Bipolar Disorder

Start: Oct 2008Est. completion: Mar 201160 patients
Phase 3Completed
NCT01825837BialBIA 2-093 1800 mg once daily [Group 1

Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder

Start: Mar 2006Est. completion: Jun 2007
Phase 2Completed
NCT01824602BialEslicarbazepine acetate 1800 mg

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Start: Feb 2006Est. completion: Nov 2006
Phase 2Terminated
NCT01822678BialEslicarbazepine Acetate

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Start: Dec 2005Est. completion: Nov 2006
Phase 2Completed
NCT00141505PfizerBifeprunox

PK Effects of Bifeprunox & Valproate in Bipolar I

Start: Feb 2005Est. completion: Dec 2006
Phase 2Completed
NCT04987658AlkermesOLZ/SAM

Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

Start: Jul 2021Est. completion: Aug 2023
Phase 1Completed
NCT04127058Vanda PharmaceuticalsIloperidone

Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

Start: Oct 2019Est. completion: Nov 201912 patients
Phase 1Completed
NCT00177463Alliance PharmaceuticalsL-carnosine

L-Carnosine for Bipolar I Disorder

Start: Sep 2004Est. completion: Dec 200747 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

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

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