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Major Depressive Disorder

268
Pipeline Programs
30
Companies
50
Clinical Trials
5 recruiting
15
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
33
5
57
2
105
66
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
16100%
+ 390 programs with unclassified modality

On Market (15)

Approved therapies currently available

AbbVie
VRAYLARApproved
cariprazine
AbbVie
Atypical Antipsychotic [EPC]oral2015
936M Part D
Otsuka
REXULTIApproved
brexpiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2015
630M Part D
Takeda
TRINTELLIXApproved
vortioxetine
Takeda
oral2013
390M Part D
Intra-Cellular Therapies
CAPLYTAApproved
lumateperone
Intra-Cellular Therapies
Atypical Antipsychotic [EPC]oral2019
195M Part D
Otsuka
ABILIFY ASIMTUFIIApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]intramuscular2023
13M Part D
Otsuka
ABILIFYApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2002
12M Part D
Pfizer
PRISTIQApproved
desvenlafaxine succinate
Pfizer
oral2008
7M Part D
Johnson & Johnson
RISPERDALApproved
risperidone
Johnson & Johnson
Atypical Antipsychotic [EPC]oral1996
4M Part D
Merck & Co.
EMENDApproved
aprepitant
Merck & Co.
Substance P/Neurokinin-1 Receptor Antagonist [EPC]oral2015
62K Part D
Takeda
VORTIOXETINE HYDROBROMIDEApproved
vortioxetine
Takeda
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013
Takeda
VORTIOXETINEApproved
vortioxetine
Takeda
oral
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
MEZOFYApproved
aripiprazole
Otsuka
oral2025
Eli Lilly and Company
PROZACApproved
fluoxetine hydrochloride
Eli Lilly and Company
oral1987

Competitive Landscape

92 companies ranked by most advanced pipeline stage

Prevail Therapeutics
11
2
12
16
DuloxetinePhase 4
DuloxetinePhase 4
DuloxetinePhase 4
DuloxetinePhase 4
DuloxetinePhase 4
+41 more programs
Lundbeck
34 programs
1
6
13
9
BrexpiprazolePhase 4Small Molecule
EscitalopramPhase 41 trial
EscitalopramPhase 41 trial
VortioxetinePhase 41 trial
VortioxetinePhase 41 trial
+29 more programs
Active Trials
NCT01427439Completed1,455
NCT00232700Completed42Est. Dec 2008
NCT02480400Completed52Est. Oct 2012
+28 more trials
Otsuka
25 programs
1
6
1
12
3
AripiprazolePhase 4Small Molecule1 trial
Aripiprazole 6-week groupPhase 41 trial
BrexpiprazolePhase 4Small Molecule1 trial
ASC-01Phase 31 trial
Antidepressant + AripiprazolePhase 3Small Molecule1 trial
+20 more programs
Active Trials
NCT01488266Unknown90Est. Mar 2013
NCT04770285Completed386Est. Oct 2022
NCT01670279Completed18Est. May 2013
+22 more trials
Angeles Therapeutics
2
7
EscitalopramPhase 41 trial
FluoxetinePhase 41 trial
Vilazodone; ViibrydPhase 41 trial
escitalopram and eszopiclonePhase 41 trial
fluoxetinePhase 41 trial
+14 more programs
Active Trials
NCT04507243Completed72Est. Mar 2024
NCT03556124Completed66Est. May 2020
NCT04556890Recruiting54Est. Dec 2027
+15 more trials
Pfizer
PfizerNEW YORK, NY
19 programs
1
11
3
EffexorPhase 41 trial
Effexor XRPhase 41 trial
venlafaxinePhase 4
DVS SRPhase 31 trial
DVS SRPhase 31 trial
+14 more programs
Active Trials
NCT07674524Not Yet Recruiting160Est. Dec 2029
NCT00770289Completed851Est. Dec 2009
NCT00242229Completed52Est. Oct 2005
+17 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
13 programs
1
Duloxetine HydrochlorideN/A1 trial
PROZAC(Fluoxetine)N/A1 trial
Internet based disease management programN/A1 trial
LY2216684PHASE_11 trial
LY2216684PHASE_11 trial
+8 more programs
Active Trials
NCT00071708Approved For Marketing
NCT00208897Completed80Est. Nov 2007
NCT00485420Completed404Est. Dec 2009
+11 more trials
Alliance Pharmaceuticals
10 programs
1
2
1
2
Cognitive Behavioral TherapyPhase 41 trial
acamprosatePhase 41 trial
Deep Brain StimulationPhase 31 trial
D-cycloserinePhase 21 trial
ZiprasidonePhase 21 trial
+5 more programs
Active Trials
NCT00562367Completed30Est. Sep 2004
NCT03749629Completed201Est. Mar 2022
NCT00245557Completed43Est. Aug 2008
+6 more trials
Takeda
9 programs
1
Mobile AppN/A1 trial
Antidepressant + SPD489PHASE_21 trial
EscitalopramPHASE_31 trial
Lu AA21004PHASE_31 trial
SPD489PHASE_31 trial
+4 more programs
Active Trials
NCT03242213Completed40Est. Sep 2019
NCT01435759Completed1,197Est. Jan 2014
NCT00642694Terminated29Est. May 2010
+5 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
9 programs
1
5
3
1
CariprazinePhase 31 trial
CariprazinePhase 31 trial
Levomilnacipran ERPhase 31 trial
ABT-436Phase 2
GLYX-13Phase 21 trial
+4 more programs
Active Trials
NCT01380704Completed51Est. Sep 2011
NCT01234558Completed115Est. Jul 2012
NCT01684163Completed369Est. Jun 2014
+5 more trials
Sandoz
8 programs
1
6
1
IloperidonePhase 41 trial
AGO178Phase 31 trial
AgomelatinePhase 31 trial
AgomelatinePhase 31 trial
AgomelatinePhase 31 trial
+3 more programs
Active Trials
NCT05666687Completed10Est. Nov 2023
NCT01156415Terminated837Est. Oct 2011
NCT00463242Completed501
+5 more trials
Luye Pharma
7 programs
6
1
Toludesvenlafaxine Hydrochloride Sustained-release TabletsPhase 41 trial
LY03005Phase 11 trial
LY03005Phase 11 trial
LY03005Phase 11 trial
LY03005Phase 11 trial
+2 more programs
Active Trials
NCT03357796Completed20Est. Dec 2017
NCT02055300Completed88Est. Aug 2014
NCT03733574Completed56Est. Jul 2018
+4 more trials
Medtronic
5 programs
1
2
Selective serotonin reuptake inhibitorsPhase 41 trial
venlafaxinePhase 41 trial
ITP StimulationPhase 1/21 trial
Deep Brain Stimulation Model 3387 Model 3389N/A1 trial
EEG Biomarkers for Predicting Response to Antidepressant TherapyN/A1 trial
Active Trials
NCT02046330Active Not Recruiting16Est. Apr 2027
NCT00289523Completed375Est. Jul 2007
NCT01921543Terminated7Est. Oct 2013
+2 more trials
Alto Neuroscience
Alto NeuroscienceMOUNTAIN VIEW, CA
5 programs
3
2
DuloxetinePhase 41 trial
SertralinePhase 41 trial
ALTO-100Phase 24 trials
ALTO-203Phase 21 trial
ALTO-300Phase 23 trials
Active Trials
NCT06656416Recruiting200Est. Oct 2027
NCT05712187Completed301Est. Oct 2024
NCT05419869Completed21Est. Jan 2023
+7 more trials
Axsome Therapeutics
Axsome TherapeuticsNY - New York
4 programs
2
1
1
AXS-05Phase 41 trial
AXS-05Phase 31 trial
AXS-05Phase 21 trial
AXS-05Phase 21 trial
Active Trials
NCT03595579Completed97Est. Jan 2019
NCT04971291Unknown312Est. Jul 2021
NCT04039022Completed876Est. Oct 2020
+1 more trials
Intra-Cellular Therapies
4
1
LumateperonePhase 31 trial
LumateperonePhase 31 trial
LumateperonePhase 31 trial
LumateperonePhase 31 trial
Active Trials
NCT05061706Completed480Est. Apr 2024
NCT05850689Recruiting470Est. Apr 2027
NCT04985942Completed485Est. Feb 2024
+1 more trials
ViiV Healthcare
3 programs
3
Bupropion, EscitalopramPhase 4
bupropion and smoking cessation behavioral interventionPhase 4
paroxetine CRPhase 4
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
1
R228060PHASE_21 trial
RISPERDAL(risperidone)PHASE_31 trial
Active Trials
NCT00073203Completed488Est. May 2004
NCT00095134Completed630Est. Nov 2005
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
1
EMEND(aprepitant)PHASE_3
Bausch Health
1 program
1
bupropion hydrobromidePhase 4
AstraZeneca
13 programs
1
5
5
TC-5214Phase 31 trial
TC-5214Phase 31 trial
TC-5214Phase 31 trial
TC-5214Phase 31 trial
TC-5214Phase 31 trial
+8 more programs
Active Trials
NCT00782964Completed364Est. Nov 2009
NCT01446692Completed2,260Est. Jan 2012
NCT01217645Completed6Est. Oct 2010
+10 more trials
Alkermes
AlkermesDUBLIN 4, Ireland
9 programs
1
1
7
ALKS 5461Phase 31 trial
ALKS 5461Phase 31 trial
ALKS 5461Phase 31 trial
ALKS 5461Phase 31 trial
ALKS 5461Phase 31 trial
+4 more programs
Active Trials
NCT01381107Completed32Est. Jul 2011
NCT01500200Completed142Est. Mar 2013
NCT03188185Completed278Est. Mar 2020
+5 more trials
MSD
9 programs
9
MK0869, aprepitantPhase 31 trial
MK0869, aprepitantPhase 31 trial
MK0869, aprepitantPhase 31 trial
MK0869, aprepitantPhase 31 trial
aprepitantPhase 31 trial
+4 more programs
Active Trials
NCT00035295Completed584Est. Dec 2003
NCT00035009Completed468Est. Mar 2004
NCT00042029Completed324Est. Oct 2003
+6 more trials
Sharp Therapeutics
9
MK0869, aprepitantPhase 3
MK0869, aprepitantPhase 3
MK0869, aprepitantPhase 3
MK0869, aprepitantPhase 3
aprepitantPhase 3
+4 more programs
Neurocrine Biosciences
1
5
NBI-1065845Phase 31 trial
NBI-1065845Phase 31 trial
NBI-1065845Phase 31 trial
NBI-1065845Phase 31 trial
NBI-1065845Phase 31 trial
+1 more programs
Active Trials
NCT06267846Completed73Est. Sep 2025
NCT06963021Recruiting200Est. Jul 2027
NCT06911112Recruiting200Est. Jul 2027
+3 more trials
Neumora Therapeutics
1
4
NMRA-335140Phase 31 trial
NMRA-335140Phase 31 trial
NMRA-335140Phase 31 trial
NMRA-335140Phase 31 trial
NMRA-335140Phase 21 trial
Active Trials
NCT04221230Completed204Est. Jun 2022
NCT06029439Terminated904Est. Aug 2026
NCT06058013Completed430Est. Jun 2026
+2 more trials
Viatris
ViatrisCANONSBURG, PA
2 programs
2
Venlafaxine ERPhase 31 trial
venlafaxine ER 75 mg/dayPhase 31 trial
Active Trials
NCT01485887Completed50Est. Jan 2014
NCT01441440Completed538Est. Mar 2014
Mochida Pharmaceutical
1
Desvenlafaxine 100 mgPhase 3
Cognition Therapeutics
2
1
1
VortioxetinePhase 2/31 trial
Autobiographical Memory FlexibilityPhase 21 trial
Memory Flexibility TrainingPhase 1/21 trial
The Modular Protocol for Mental HealthPhase 1/21 trial
Ketamine HydrochlorideN/A1 trial
+1 more programs
Active Trials
NCT04209296Completed891Est. Sep 2023
NCT02508493Completed200Est. Jul 2016
NCT02371291Completed60Est. Jan 2017
+3 more trials
Syndeio Biosciences
3
1
2
ZelquistinelPhase 21 trial
ZelquistinelPhase 21 trial
AGN-241751Phase 1/21 trial
GATE-101Phase 11 trial
apimostinelPhase 11 trial
+1 more programs
Active Trials
NCT04618263Terminated18Est. Aug 2021
NCT05597241Completed40Est. Apr 2023
NCT04981561Completed68Est. Dec 2017
+3 more trials
Astellas
AstellasChina - Shenyang
3 programs
2
1
quetiapine extended releasePhase 21 trial
FK949EPhase 11 trial
FK949EPhase 11 trial
Active Trials
NCT01919008Completed16Est. Jun 2012
NCT01924520Completed32Est. May 2011
NCT01725282Completed172Est. Aug 2013

+62 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Luye PharmaToludesvenlafaxine Hydrochloride Sustained-release Tablets
Axsome TherapeuticsAXS-05
OtsukaBrexpiprazole
Alto NeuroscienceDuloxetine
Alto NeuroscienceSertraline
LundbeckVortioxetine
LundbeckVortioxetine
LundbeckVortioxetine
LundbeckVortioxetine
Verona PharmaVortioxetine
BrainsWayBrainsway DTMS with intermittent Theta Burst Stimulation
Angeles Therapeuticslevomilnacipran
TakedaVortioxetine
Lundbeckvortioxetine
Pfizerdesvenlafaxine

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 12,458 patients across 50 trials

NCT06426485Luye PharmaToludesvenlafaxine Hydrochloride Sustained-release Tablets

To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets

Start: May 2024Est. completion: Jun 2027736 patients
Phase 4Not Yet Recruiting

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Start: Dec 2023Est. completion: Mar 2026350 patients
Phase 4Recruiting
NCT04830215OtsukaBrexpiprazole

Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Start: Apr 2021Est. completion: May 2022122 patients
Phase 4Completed

Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

Start: Oct 2020Est. completion: May 20230
Phase 4Withdrawn

Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

Start: Oct 2020Est. completion: May 20230
Phase 4Withdrawn

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

Start: Jun 2020Est. completion: Feb 2022605 patients
Phase 4Completed

Vortioxetine in Patients With Depression and Early Dementia

Start: Feb 2020Est. completion: Jul 202282 patients
Phase 4Completed

Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India

Start: Feb 2020Est. completion: Mar 2022400 patients
Phase 4Completed

Study With Vortioxetine on Emotional Functioning in Patients With Depression

Start: Feb 2019Est. completion: Feb 2020150 patients
Phase 4Completed

Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

Start: Feb 2019Est. completion: Feb 2023362 patients
Phase 4Completed
NCT04679753BrainsWayBrainsway DTMS with intermittent Theta Burst Stimulation

Brainsway DTMS for Treatment of MDD Using iTBS

Start: Jan 2019Est. completion: Jul 2020177 patients
Phase 4Completed

Trial of Levomilnacipran in Geriatric Depression

Start: Jun 2016Est. completion: Dec 201829 patients
Phase 4Completed
NCT02371980TakedaVortioxetine

Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)

Start: Feb 2015Est. completion: Apr 20191,106 patients
Phase 4Completed

Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine

Start: Feb 2015Est. completion: Jul 2017226 patients
Phase 4Completed
NCT02200406Pfizerdesvenlafaxine

Desvenlafaxine in Opioid-Dependent Patients

Start: Jul 2014Est. completion: Jan 201718 patients
Phase 4Completed

Vilazodone for Treatment of Geriatric Depression

Start: Jul 2012Est. completion: Sep 201565 patients
Phase 4Completed

Lexapro®'s Efficacy After Dose Escalation in Remission Study

Start: May 2012Est. completion: Dec 201660 patients
Phase 4Completed

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

Start: Apr 2012Est. completion: Dec 201420 patients
Phase 4Completed
NCT01696617OtsukaAripiprazole 6-week group

Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Start: Feb 2012Est. completion: Feb 201946 patients
Phase 4Completed
NCT01492621Pfizerdesvenlafaxine

Effect of Antidepressants on White Matter Structure

Start: Nov 2011Est. completion: Nov 201340 patients
Phase 4Unknown
NCT01429831OtsukaAripiprazole

Aripiprazole for the Augmentation of Antidepressant Therapy

Start: Sep 2011Est. completion: May 2013300 patients
Phase 4Completed

Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)

Start: Apr 201026 patients
Phase 4Completed

A Study of the Neurobiology of Depression

Start: Jan 2010Est. completion: Mar 201360 patients
Phase 4Completed

Biomarkers for Outcomes In Late-life Depression (BOLD)

Start: Oct 2009Est. completion: Oct 201280 patients
Phase 4Completed

A Study of Patients With Major Depressive Disorder and Residual Apathy

Start: Sep 2009Est. completion: Dec 2010483 patients
Phase 4Completed

Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder

Start: Apr 2009Est. completion: Oct 20110
Phase 4Withdrawn
NCT01541475GSKBupropion, Escitalopram

Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Start: Mar 2009Est. completion: Jan 201160 patients
Phase 4Completed
NCT00824044Alliance PharmaceuticalsCognitive Behavioral Therapy

Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression

Start: Jul 2008Est. completion: Mar 201139 patients
Phase 4Completed
NCT00628914Angeles Therapeuticsescitalopram and eszopiclone

Brain Mechanisms and Targeting Insomnia in Major Depression

Start: May 2008Est. completion: Feb 201060 patients
Phase 4Unknown

Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults

Start: May 2007Est. completion: Apr 201030 patients
Phase 4Completed

Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

Start: Apr 2007Est. completion: Mar 20081,151 patients
Phase 4Completed

Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism

Start: Mar 2007Est. completion: May 201023 patients
Phase 4Completed

Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Start: Feb 200725 patients
Phase 4Unknown
NCT00422162Boehringer IngelheimDuloxetine hydrochloride

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Start: Feb 2007Est. completion: Aug 2008339 patients
Phase 4Completed
NCT00406848Boehringer Ingelheimduloxetine hydrochloride

A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients

Start: Nov 2006Est. completion: Nov 2009370 patients
Phase 4Completed

Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Start: Sep 2005Est. completion: Nov 2006294 patients
Phase 4Completed
NCT00186446GSKbupropion and smoking cessation behavioral intervention

Treatment of Nicotine Dependence and Acute Depression

Start: Jun 2004Est. completion: Sep 200720 patients
Phase 4Completed
NCT00157547MedtronicSelective serotonin reuptake inhibitors

Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression

Start: Apr 2003Est. completion: Aug 200695 patients
Phase 4Completed

Electroencephalography (EEG) Biomarkers of Response in Depression

Start: Nov 2002Est. completion: Dec 200544 patients
Phase 4Completed
NCT00049972GSKparoxetine CR

Major Depressive Disorder Study In Adults

Start: Sep 2002Est. completion: Sep 2003646 patients
Phase 4Completed

Neurophysiologic Monitoring of Antidepressant Treatment

Start: Aug 1994Est. completion: Aug 199624 patients
Phase 4Completed

Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

Est. completion: May 2005369 patients
Phase 3Completed

Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder

Est. completion: May 2004247 patients
Phase 3Completed

Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Est. completion: Nov 2004480 patients
Phase 3Completed

Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

Est. completion: Mar 2005369 patients
Phase 3Completed
NCT07204314TakedaVortioxetine tablets

A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder

Start: Oct 2025Est. completion: Sep 2029180 patients
Phase 3Recruiting

A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Start: Aug 2025Est. completion: Jul 2028550 patients
Phase 3Recruiting

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

Start: Jul 2025Est. completion: Jul 2027450 patients
Phase 3Active Not Recruiting

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Start: May 2025Est. completion: Jul 2027200 patients
Phase 3Recruiting

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Start: Apr 2025Est. completion: May 2030850 patients
Phase 3Recruiting

Related Jobs

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

105 late-stage (Phase 3) programs, potential near-term approvals
5 actively recruiting trials targeting 12,458 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.