Depressive Disorder, Major

31
Pipeline Programs
14
Companies
31
Clinical Trials
3 recruiting
8
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
9
0
8
10
Early DiscoveryClinical DevelopmentMarket

On Market (8)

Approved therapies currently available

Takeda
ACTOPLUS METApproved
pioglitazone and metformin hydrochloride
Takeda
oral2005
Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004
Corcept Therapeutics
KORLYMApproved
mifepristone
Corcept Therapeutics
Progestin Antagonist [EPC]oral2012
U
MIFEPREXApproved
mifepristone
Unknown Company
oral2000
U
MIFEPRISTONEApproved
mifepristone
Unknown Company
Progestin Antagonist [EPC]oral2019
Takeda
TRINTELLIXApproved
vortioxetine
Takeda
oral2013
U
VORTIOXETINEApproved
vortioxetine
Unknown Company
oral
U
VORTIOXETINE HYDROBROMIDEApproved
vortioxetine
Unknown Company

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
10 programs
2
4
3
1
DuloxetinePhase 41 trial
DuloxetinePhase 31 trial
DuloxetinePhase 31 trial
Duloxetine HydrochloridePhase 31 trial
BI 1358894Phase 21 trial
+5 more programs
Active Trials
NCT03854578Completed73Est. Sep 2019
NCT04937829Completed59Est. Nov 2023
NCT04521478Completed389Est. Feb 2024
+7 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
3 programs
2
1
1
duloxetinePhase 31 trial
LY2216684Phase 11 trial
LY2216684Phase 11 trial
Active Trials
NCT01389765Completed24Est. Aug 2011
NCT01389752Completed22Est. Sep 2011
NCT00191685Completed200Est. Sep 2005
Takeda
TakedaTOKYO, Japan
3 programs
2
1
1
VortioxetinePhase 31 trial
ACTOPLUS MET(Pioglitazone)Phase 21 trial
VortioxetinePhase 21 trial
Active Trials
NCT00671515Completed23Est. Nov 2011
NCT02919501Completed55Est. Apr 2017
NCT01153009Completed614Est. Mar 2012
Corcept Therapeutics
Corcept TherapeuticsCA - Redwood City
1 program
1
1
MifepristonePhase 31 trial
Active Trials
NCT00208156Completed87Est. Nov 2006
Alliance Pharmaceuticals
1 program
1
EstrogenPhase 41 trial
Active Trials
NCT00229450Completed17Est. Aug 2004
Biogen
BiogenCAMBRIDGE, MA
2 programs
2
SAGE-217Phase 31 trial
SAGE-217Phase 33 trials
Active Trials
NCT04476030Completed440Est. Dec 2021
NCT04442490Completed543Est. Apr 2021
NCT03864614Completed1,515Est. Jun 2023
+1 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
NMDA Antagonist, CP-101,606Phase 21 trial
Active Trials
NCT00163059Completed30Est. Dec 2005
Relmada Therapeutics
Relmada TherapeuticsCORAL GABLES, FL
1 program
1
REL-1017Phase 21 trial
Active Trials
NCT03051256CompletedEst. Sep 2019
Seelos Therapeutics
Seelos TherapeuticsNY - New York
1 program
1
SLS-002Phase 21 trial
Active Trials
NCT04669665Completed164Est. Jul 2023
Abbott
AbbottABBOTT PARK, IL
2 programs
Deep Brain StimulationN/A1 trial
Deep Brain Stimulation, Libra Deep Brain Stimulation SystemN/A1 trial
Active Trials
NCT01331330Completed9Est. Jan 2015
NCT00617162Terminated125Est. Jun 2015
QT
Q TherapeuticsUT - Salt Lake City
1 program
L-dopa/CarbidopaN/A1 trial
Active Trials
NCT05909267RecruitingEst. Oct 2025
Verona Pharma
Verona PharmaUK - London
1 program
Psychoeducational Family InterventionN/A1 trial
Active Trials
NCT05988333RecruitingEst. Sep 2026
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
RESPECT-DN/A1 trial
Active Trials
NCT01583400Completed131Est. Oct 2013
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
Valence-Specific Ecological Momentary InterventionN/A1 trial
Active Trials
NCT06311136Recruiting200Est. Aug 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Boehringer IngelheimDuloxetine
Alliance PharmaceuticalsEstrogen
BiogenSAGE-217
BiogenSAGE-217
BiogenSAGE-217
TakedaVortioxetine
Boehringer IngelheimDuloxetine Hydrochloride
Boehringer IngelheimDuloxetine
Corcept TherapeuticsMifepristone
Boehringer IngelheimDuloxetine
Eli Lilly and Companyduloxetine
Boehringer IngelheimBI 1569912
Boehringer IngelheimBI 1569912
Seelos TherapeuticsSLS-002
Boehringer IngelheimBI 1358894

Showing 15 of 31 trials with date data

Clinical Trials (31)

Total enrollment: 6,592 patients across 31 trials

Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression

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

Estrogen and Perimenopausal Depression

Start: Apr 2002Est. completion: Aug 200417 patients
Phase 4Completed

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Start: Nov 2020Est. completion: Dec 2021440 patients
Phase 3Completed

A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

Start: May 2020Est. completion: Apr 2021543 patients
Phase 3Completed

A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

Start: Feb 2019Est. completion: Jun 20231,515 patients
Phase 3Completed
NCT01153009TakedaVortioxetine

Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Start: Jun 2010Est. completion: Mar 2012614 patients
Phase 3Completed
NCT00191919Boehringer IngelheimDuloxetine Hydrochloride

A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

Start: May 2005Est. completion: May 2006310 patients
Phase 3Completed

Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain

Start: May 2005327 patients
Phase 3Completed

A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Start: May 2005Est. completion: Nov 200687 patients
Phase 3Completed

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Start: Mar 2005Est. completion: Jan 2008514 patients
Phase 3Completed

Duloxetine in the Treatment of Melancholic Depression

Start: May 2004Est. completion: Sep 2005200 patients
Phase 3Completed

A Study to Test Different Doses of BI 1569912 in People With Depression

Start: Oct 2024Est. completion: May 2025224 patients
Phase 2Completed

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine

Start: Mar 2024Est. completion: Mar 202584 patients
Phase 2Completed

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide

Start: Dec 2020Est. completion: Jul 2023164 patients
Phase 2Completed

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Start: Nov 2020Est. completion: Feb 2024389 patients
Phase 2Completed

A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression

Start: Jun 2020Est. completion: May 202245 patients
Phase 2Terminated

Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD

Start: May 2018Est. completion: Sep 2019
Phase 2Completed

A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

Start: Nov 2016Est. completion: Sep 201729 patients
Phase 2Completed
NCT02919501TakedaVortioxetine

Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

Start: Sep 2016Est. completion: Apr 201755 patients
Phase 2Completed
NCT00671515TakedaPioglitazone

Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

Start: Apr 2008Est. completion: Nov 201123 patients
Phase 2Completed
NCT00163059PfizerNMDA Antagonist, CP-101,606

The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD

Start: May 2004Est. completion: Dec 200530 patients
Phase 2Completed

A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication

Start: Jul 2021Est. completion: Nov 202359 patients
Phase 1Completed

A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions

Start: Mar 2019Est. completion: Sep 201973 patients
Phase 1Completed

A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects

Start: Jul 2011Est. completion: Sep 201122 patients
Phase 1Completed

A Study to Evaluate the Effect of Food on LY2216684

Start: Jul 2011Est. completion: Aug 201124 patients
Phase 1Completed
NCT06311136Heidelberg PharmaValence-Specific Ecological Momentary Intervention

Effectiveness of an Ecological Momentary Emotion Regulation Intervention

Start: Jan 2024Est. completion: Aug 2025200 patients
N/ARecruiting
NCT05988333Verona PharmaPsychoeducational Family Intervention

Psychoeducational Intervention for Families With a Member Affected by Major Depression

Start: Sep 2023Est. completion: Sep 2026
N/ARecruiting

Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

Start: Jul 2023Est. completion: Oct 2025
N/ARecruiting

Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial

Start: Sep 2011Est. completion: Oct 2013131 patients
N/ACompleted
NCT01331330AbbottDeep Brain Stimulation

European Deep Brain Stimulation (DBS) Depression Study

Start: May 2011Est. completion: Jan 20159 patients
N/ACompleted
NCT00617162AbbottDeep Brain Stimulation, Libra Deep Brain Stimulation System

Deep Brain Stimulation for Major Depressive Disorder

Start: Mar 2008Est. completion: Jun 2015125 patients
N/ATerminated

Phase Legend

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

Key Insights

8 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 6,592 patients
14 companies competing in this space