Major Depressive Disorder (MDD)

9
Pipeline Programs
10
Companies
13
Clinical Trials
4 recruiting
2
Approved Products

Pipeline by Development Stage

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

On Market (2)

Approved therapies currently available

VP
BYSANTIApproved
milsaperidone
Vanda Pharmaceuticals
oral2026
U
DULOXETINE HYDROCHLORIDEApproved
duloxetine hydrochloride
Unknown Company
oral2013

Competitive Landscape

10 companies ranked by most advanced pipeline stage

VP
Vanda PharmaceuticalsWASHINGTON, DC
1 program
1
1
MilsaperidonePhase 31 trial
Active Trials
NCT06830044Recruiting500Est. Mar 2028
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
Duloxetine hydrochloridePhase 41 trial
Active Trials
NCT00960986Completed249Est. Apr 2011
ST
2 programs
2
SPT-300Phase 21 trial
SPT-300Phase 21 trial
Active Trials
NCT07065240Recruiting360Est. Mar 2027
NCT07161700Enrolling By Invitation360Est. May 2027
Acadia Pharmaceuticals
1 program
1
ACP-211Phase 21 trial
Active Trials
NCT07284667Recruiting153Est. Sep 2027
Draig Therapeutics
Draig TherapeuticsUK - Cardiff
1 program
1
DT-101Phase 21 trial
Active Trials
NCT07300969RecruitingEst. Aug 2027
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
FosigotifatorPhase 13 trials
Active Trials
NCT06594016No Longer Available
NCT06618118Terminated20Est. Sep 2025
NCT04948645Terminated31Est. Jul 2025
Concerto Biosciences
Concerto BiosciencesMA - Cambridge
1 program
Active tDCSN/A1 trial
Active Trials
NCT06714643Not Yet Recruiting105Est. Jan 2026
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
NCT03012724UnknownEst. Dec 2020
Neuronetics
NeuroneticsMALVERN, PA
1 program
TMSN/A1 trial
Active Trials
NCT05541302Completed6,456Est. Aug 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Boehringer IngelheimDuloxetine hydrochloride
Vanda PharmaceuticalsMilsaperidone
Draig TherapeuticsDT-101
Acadia PharmaceuticalsACP-211
Seaport TherapeuticsSPT-300
Seaport TherapeuticsSPT-300
AbbVieFosigotifator
AbbVieFosigotifator
Concerto BiosciencesActive tDCS
BrainsWayH7-Coil
AstraZenecaEuropean Drug Utilization Study
NeuroneticsTMS

Clinical Trials (13)

Total enrollment: 9,048 patients across 13 trials

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

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

Start: Dec 2025Est. completion: Aug 2027
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
NCT06618118AbbVieFosigotifator

A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder

Start: Oct 2024Est. completion: Sep 202520 patients
Phase 1Terminated
NCT04948645AbbVieFosigotifator

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis

Start: Sep 2021Est. completion: Jul 202531 patients
Phase 1Terminated
NCT06594016AbbVieFosigotifator

Expanded Access to Fosigotifator

N/ANo Longer Available

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 2020
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

1 late-stage (Phase 3) programs — potential near-term approvals
4 actively recruiting trials targeting 9,048 patients
10 companies competing in this space