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Major Depressive Disorder (MDD)

27
Pipeline Programs
27
Companies
33
Clinical Trials
9 recruiting
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
7
0
10
10
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
3100%
+ 36 programs with unclassified modality

On Market (6)

Approved therapies currently available

Otsuka
REXULTIApproved
brexpiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2015
630M 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
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
MEZOFYApproved
aripiprazole
Otsuka
oral2025

Competitive Landscape

26 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
6 programs
5
1
BrexpiprazolePhase 4Small Molecule1 trial
ADTPhase 31 trial
AripiprazolePhase 3Small Molecule1 trial
EscitalopramPhase 31 trial
EscitalopramPhase 31 trial
+1 more programs
Active Trials
NCT02012218Completed61Est. Oct 2014
NCT01123707Terminated173Est. Sep 2011
NCT01111552Terminated237Est. Sep 2011
+3 more trials
Prevail Therapeutics
2 programs
1
1
Duloxetine hydrochloridePhase 41 trial
LY2216684Phase 31 trial
Active Trials
NCT01187407Completed1,480Est. Aug 2013
NCT00960986Completed249Est. Apr 2011
Servier
ServierFrance - Suresnes
1 program
1
AgomelatinePhase 41 trial
Active Trials
NCT01483053Unknown40Est. Feb 2015
Lundbeck
LundbeckDenmark - Copenhagen
1 program
1
BrexpiprazolePhase 4Small Molecule
ViiV Healthcare
ViiV HealthcareNC - Durham
4 programs
2
2
Extended-Release Bupropion HydrochloridePhase 31 trial
Extended-release Bupropion HydrochloridePhase 31 trial
323U66 SRPhase 21 trial
RadafaxinePhase 21 trial
Active Trials
NCT00330616Completed35Est. Nov 2007
NCT00057239Completed546Est. May 2004
NCT00051259Completed420Est. Jun 2004
+1 more trials
Luye Pharma
Luye PharmaChina - Shanghai
1 program
1
LY03005 extended-release tabletPhase 31 trial
Active Trials
NCT04853407Completed558Est. Dec 2020
Sandoz
SandozAustria - Kundl
1 program
1
agomelatinePhase 31 trial
Active Trials
NCT00411242Completed503
Acadia Pharmaceuticals
1 program
1
ACP-211Phase 21 trial
Active Trials
NCT07284667Recruiting153Est. Sep 2027
Cognition Therapeutics
Cognition TherapeuticsPA - Pittsburgh
1 program
1
Dextromethorphan-BupropionPhase 21 trial
Active Trials
NCT07523048Recruiting30Est. Jan 2027
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
Dextromethorphan-BupropionPhase 2
Chengdu Kanghong Pharmaceutical Group
1
KH607 tabletsPhase 21 trial
Active Trials
NCT07101120Completed126Est. Feb 2026
Supernus Pharmaceuticals
1 program
1
SPN-821 2400 mgPhase 21 trial
Active Trials
NCT07226661Recruiting230Est. Jan 2027
GSK
GSKLONDON, United Kingdom
4 programs
323U66 SRPHASE_2
RadafaxinePHASE_2
Extended-Release Bupropion HydrochloridePHASE_3
Extended-release Bupropion HydrochloridePHASE_3
Seaport Therapeutics
2 programs
SPT-300PHASE_21 trial
SPT-300PHASE_21 trial
Active Trials
NCT07161700Enrolling By Invitation360Est. May 2027
NCT07065240Recruiting360Est. Mar 2027
NeuroQore
NeuroQoreCA - Mountain View
1 program
Accelerated rTMS treatmentN/A1 trial
Active Trials
NCT06772987Completed50Est. May 2025
Concerto Biosciences
Concerto BiosciencesMA - Cambridge
1 program
Active tDCSN/A1 trial
Active Trials
NCT06714643Not Yet Recruiting105Est. Jan 2026
Combined Therapeutics
1 program
Dextromethorphan-BupropionN/A1 trial
Active Trials
NCT06957223Completed80Est. Dec 2025
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
European Drug Utilization StudyN/A1 trial
Active Trials
NCT01594996Completed814Est. Mar 2014
BrainsWay
BrainsWayJerusalem, Israel
1 program
H7-CoilN/A1 trial
Active Trials
NCT03012724Unknown106Est. Dec 2020
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
1 program
Motivationally Enhanced Compensatory Cognitive Training for Major Depressive DisorderN/A1 trial
Active Trials
NCT06728774Recruiting24Est. Jun 2026
Neuronetics
NeuroneticsMALVERN, PA
1 program
TMSN/A1 trial
Active Trials
NCT05541302Completed6,456Est. Aug 2022
Sooma
SoomaFinland - Helsinki
1 program
Transcranial direct current stimulationN/A1 trial
Active Trials
NCT06976697Recruiting200Est. Dec 2026
Acacia Pharma
Acacia PharmaUK - Cambridge
1 program
fNIRS measurementN/A1 trial
Active Trials
NCT07294924Terminated11Est. Mar 2026
Draig Therapeutics
Draig TherapeuticsUK - Cardiff
1 program
DT-101PHASE_22 trials
Active Trials
NCT07610473Recruiting118Est. May 2027
NCT07300969Recruiting300Est. Aug 2027
Vanda Pharmaceuticals
Vanda PharmaceuticalsWASHINGTON, DC
1 program
MilsaperidonePHASE_31 trial
Active Trials
NCT06830044Recruiting500Est. Mar 2028
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
Duloxetine hydrochloridePHASE_4

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
OtsukaBrexpiprazole
ServierAgomelatine
Prevail TherapeuticsDuloxetine hydrochloride
Vanda PharmaceuticalsMilsaperidone
Luye PharmaLY03005 extended-release tablet
OtsukaADT
Prevail TherapeuticsLY2216684
OtsukaAripiprazole
OtsukaEscitalopram
OtsukaEscitalopram
OtsukaEscitalopram
Sandozagomelatine
ViiV HealthcareExtended-release Bupropion Hydrochloride
ViiV HealthcareExtended-Release Bupropion Hydrochloride
Draig TherapeuticsDT-101

Showing 15 of 33 trials with date data

Clinical Trials (33)

Total enrollment: 15,098 patients across 33 trials

NCT05504486OtsukaBrexpiprazole

Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

Start: Aug 2022Est. completion: Apr 20230
Phase 4Withdrawn

Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder (MDD)

Start: Jan 2014Est. completion: Feb 201540 patients
Phase 4Unknown
NCT00960986Prevail TherapeuticsDuloxetine hydrochloride

A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder

Start: Aug 2009Est. completion: Apr 2011249 patients
Phase 4Completed

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

Start: Mar 2025Est. completion: Mar 2028500 patients
Phase 3Recruiting
NCT04853407Luye PharmaLY03005 extended-release tablet

A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

Start: Dec 2018Est. completion: Dec 2020558 patients
Phase 3Completed

Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

Start: Nov 2013Est. completion: Oct 201461 patients
Phase 3Completed

A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

Start: Mar 2011Est. completion: Aug 20131,480 patients
Phase 3Completed
NCT01123707OtsukaAripiprazole

To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start: Nov 2010Est. completion: Sep 2011173 patients
Phase 3Terminated
NCT01111565OtsukaEscitalopram

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start: Oct 2010Est. completion: Sep 2011137 patients
Phase 3Terminated
NCT01111552OtsukaEscitalopram

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start: Jul 2010Est. completion: Sep 2011237 patients
Phase 3Terminated
NCT01111539OtsukaEscitalopram

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start: Jul 2010Est. completion: Sep 2011211 patients
Phase 3Terminated

Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Start: Dec 2006503 patients
Phase 3Completed
NCT00051272ViiV HealthcareExtended-release Bupropion Hydrochloride

Effects Of Antidepressants On Sexual Functioning In Adults

Start: Jan 2003Est. completion: Jun 2004425 patients
Phase 3Completed
NCT00051259ViiV HealthcareExtended-Release Bupropion Hydrochloride

Effects of Antidepressants on Sexual Functioning

Start: Jan 2003Est. completion: Jun 2004420 patients
Phase 3Completed

A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

Start: May 2026Est. completion: May 2027118 patients
Phase 2Recruiting

Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder

Start: Jan 2026Est. completion: Jan 2027230 patients
Phase 2Recruiting

A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression

Start: Dec 2025Est. completion: Aug 2027300 patients
Phase 2Recruiting
NCT07523048Cognition TherapeuticsDextromethorphan-Bupropion

Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder

Start: Nov 2025Est. completion: Jan 202730 patients
Phase 2Recruiting

ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Start: Nov 2025Est. completion: Sep 2027153 patients
Phase 2Recruiting

An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)

Start: Sep 2025Est. completion: May 2027360 patients
Phase 2Enrolling By Invitation

A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)

Start: Jun 2025Est. completion: Mar 2027360 patients
Phase 2Recruiting

A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major Depressive Disorder

Start: Mar 2025Est. completion: Feb 2026126 patients
Phase 2Completed

Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

Start: May 2006Est. completion: Nov 200735 patients
Phase 2Completed

An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder

Start: Mar 2003Est. completion: May 2004546 patients
Phase 2Completed
NCT07294924Acacia PharmafNIRS measurement

Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

Start: Jan 2026Est. completion: Mar 202611 patients
N/ATerminated
NCT06976697SoomaTranscranial direct current stimulation

Home-Based tDCS Treatment Of Major Depressive Disorder

Start: Jun 2025Est. completion: Dec 2026200 patients
N/ARecruiting
NCT06957223Combined TherapeuticsDextromethorphan-Bupropion

Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder

Start: May 2025Est. completion: Dec 202580 patients
N/ACompleted
NCT06728774Oregon TherapeuticsMotivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder

Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits

Start: May 2025Est. completion: Jun 202624 patients
N/ARecruiting
NCT06772987NeuroQoreAccelerated rTMS treatment

NQ TMS for MDD Therapy Using 1 Day x 3 Sessions Protocol for Adult Patient

Start: Jan 2025Est. completion: May 202550 patients
N/ACompleted

Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Start: Jan 2025Est. completion: Jan 2026105 patients
N/ANot Yet Recruiting

Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)

Start: Mar 2017Est. completion: Dec 2020106 patients
N/AUnknown
NCT01594996AstraZenecaEuropean Drug Utilization Study

European Drug Utilization Study

Start: Apr 2012Est. completion: Mar 2014814 patients
N/ACompleted

Retrospective TMS Therapy for Adults With MDD

Start: Nov 2008Est. completion: Aug 20226,456 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

10 late-stage (Phase 3) programs, potential near-term approvals
9 actively recruiting trials targeting 15,098 patients
27 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.