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Major Depressive Disorder (MDD)

27
Pipeline Programs
27
Companies
31
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
MEZOFYApproved
aripiprazole
Otsuka
oral2025
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013

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
NCT01111565Terminated137Est. Sep 2011
+3 more trials
Prevail Therapeutics
2 programs
1
1
Duloxetine hydrochloridePhase 4
LY2216684Phase 3
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 3
Extended-release Bupropion HydrochloridePhase 3
323U66 SRPhase 2
RadafaxinePhase 2
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
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
Dextromethorphan-BupropionPhase 2
Cognition Therapeutics
Cognition TherapeuticsPA - Pittsburgh
1 program
1
Dextromethorphan-BupropionPhase 21 trial
Active Trials
NCT07523048Recruiting30Est. Jan 2027
Chengdu Kanghong Pharmaceutical Group
1
KH607 tabletsPhase 21 trial
Active Trials
NCT07101120Not Yet Recruiting120Est. Apr 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_21 trial
RadafaxinePHASE_21 trial
Extended-Release Bupropion HydrochloridePHASE_31 trial
Extended-release Bupropion HydrochloridePHASE_31 trial
Active Trials
NCT00330616Completed35Est. Nov 2007
NCT00057239Completed546Est. May 2004
NCT00051259Completed420Est. Jun 2004
+1 more trials
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
NCT06957223Active Not Recruiting80Est. 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
NCT07294924Recruiting100Est. Dec 2026
Draig Therapeutics
Draig TherapeuticsUK - Cardiff
1 program
DT-101PHASE_21 trial
Active Trials
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_41 trial
Active Trials
NCT00960986Completed249Est. Apr 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
OtsukaBrexpiprazole
ServierAgomelatine
Boehringer IngelheimDuloxetine hydrochloride
Vanda PharmaceuticalsMilsaperidone
Luye PharmaLY03005 extended-release tablet
OtsukaADT
OtsukaAripiprazole
OtsukaEscitalopram
OtsukaEscitalopram
OtsukaEscitalopram
Sandozagomelatine
GSKExtended-Release Bupropion Hydrochloride
GSKExtended-release Bupropion Hydrochloride
Supernus PharmaceuticalsSPN-821 2400 mg
Draig TherapeuticsDT-101

Showing 15 of 31 trials with date data

Clinical Trials (31)

Total enrollment: 13,583 patients across 31 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
NCT00960986Boehringer IngelheimDuloxetine 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
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
NCT00051259GSKExtended-Release Bupropion Hydrochloride

Effects of Antidepressants on Sexual Functioning

Start: Jan 2003Est. completion: Jun 2004420 patients
Phase 3Completed
NCT00051272GSKExtended-release Bupropion Hydrochloride

Effects Of Antidepressants On Sexual Functioning In Adults

Start: Jan 2003Est. completion: Jun 2004425 patients
Phase 3Completed

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

Start: Aug 2025Est. completion: Apr 2026120 patients
Phase 2Not Yet Recruiting

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

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

Start: May 2006Est. completion: Nov 200735 patients
Phase 2Completed
NCT00057239GSKRadafaxine

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: Dec 2025Est. completion: Dec 2026100 patients
N/ARecruiting
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/AActive Not Recruiting
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 13,583 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.