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Drug Pipeline Review Therapy area: Major Depressive Disorder40–50 pages · PDF + Excel tracker

Major Depressive Disorder Drug Pipeline: 65 Assets by Phase

Major Depressive Disorder pipeline: 65 drug candidates in clinical development, 15 in Phase III, from 51 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Major Depressive Disorder Data as of 3 Oct 2026
Candidates in development 65assets Desk-reviewed How this number is madeEvery drug named in an interventional trial, merged across code, generic and brand names, with a live or recent industry trial. Placebo and comparator arms excluded.
Phase III 1523% of pipeline Registry How this number is madeCandidates whose highest phase in a live or recent trial is Phase III (Phase II/III counts as Phase II).
Phase II 3757% of pipeline Registry
Phase I 1320% of pipeline Registry
Sponsors 51top 5 hold 22% Registry How this number is madeCompanies credited with at least one candidate: the lead sponsor on most of that candidate's industry trials.
Registered trials 705263 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 3 Oct 2021.
Readouts in 12 months 16Phase II or later Sponsor dates How this number is madeCandidates with a registered primary completion date in the next 12 months. Dates are the sponsor's own and often move.
Trials with US sites 37854% · Europe 26% Registry How this number is madeTrials with at least one site in the United States; Europe is the EU/EEA, the UK and Switzerland. A trial counts in every region where it has a site.

Candidates by highest phase reached

Phase I13
Phase II37
Phase III15

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
BPL-003Phase IINov 2026 (est.)
ALTO-300Phase IIDec 2026 (est.)
SeltorexantPhase IIIDec 2026 (est.)

Candidates in development by lead sponsor

Alto Neuroscience3
Janssen Research & Development, LLC3
Mapi Pharma Ltd.3
Otsuka Pharmaceutical Development & Commercialization, Inc.3
ACADIA Pharmaceuticals Inc.2

Phase II and III primary completions per quarter

Q4 20264
Q1 20274
Q2 20272
Q3 20276
Q4 20274
Q1 20285
Q2 20281
Q3 20280

Answers at a glance

  • 15 of 65 major depressive disorder candidates (23%) are in Phase III.
  • Alto Neuroscience runs the largest major depressive disorder pipeline, with 3 candidates.
  • 16 readouts are due in 12 months; the next is BPL-003 in Nov 2026.
  • 162 trials are recruiting patients now; 54% of all trials have a US site and 26% a European one.
65 candidates705 trials66 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Edition: data as of 3 Oct 2026 Next refresh: by 1 Jan 2027 Change: Since 3 Oct 2026: assets −1, Phase III 0, trials 0

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A sample of the Major Depressive Disorder Pipeline Review: the full chapter list, the tracker columns and two asset profiles from the report. The Research Desk reviews your request and emails it, usually within one business day.

Major Depressive Disorder has 65 drug candidates in active clinical development, of which 15 are in Phase III, 37 in Phase II and 13 in Phase I, according to Douglas Insights' count of 705 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The major depressive disorder drug pipeline is the set of medicines that sponsors are still testing in people for this condition: each candidate is counted once, at the highest phase it has reached in a running or recently completed trial. Medicines already on the market and studied only in Phase IV trials are kept out of the count.

How many major depressive disorder drugs are in each phase of development?

Douglas Insights counts 15 major depressive disorder candidates in Phase III, 23% of the 65 assets in development; Phase II holds 37 and Phase I holds 13.

Phase I13Phase II37Phase III15
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III1523%
Phase II3757%
Phase I1320%
Total65100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each major depressive disorder asset appears in exactly one row. The 263 trials still recruiting or running carry 37% of the 705 registered trials in scope.

Which approved major depressive disorder medicines are still in trials?

11 medicines already on the market are still being tested in major depressive disorder Phase IV trials; Escitalopram has the most, with 48 registered trials.

MedicineLead sponsorRegistered trials
EscitalopramSeveral sponsors48
EsketamineJanssen Research & Development, LLC37
VortioxetineH. Lundbeck A/S15
AripiprazoleOtsuka Pharmaceutical Development & Commercialization, Inc.14
FluoxetineAllergan12
BrexpiprazoleOtsuka Pharmaceutical Co., Ltd.8
LumateperoneIntra-Cellular Therapies, Inc.8
AXS-05Axsome Therapeutics, Inc.7

Post-approval major depressive disorder trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many major depressive disorder trials are recruiting patients now?

162 major depressive disorder trials are recruiting patients and 59 more have not started recruiting yet, out of 705 interventional trials in scope; together they make up 31% of the trial base.

Registry statusTrialsShare
Completed32646%
Recruiting16223%
Not yet recruiting598.4%
Terminated436.1%
Status not verified395.5%
Active, not recruiting334.7%
Withdrawn304.3%
Enrolling by invitation91.3%
Suspended40.6%

Terminated, suspended and withdrawn major depressive disorder trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the major depressive disorder pipeline?

Alto Neuroscience leads the major depressive disorder pipeline with 3 candidates; the top 5 sponsors hold 22% of the 65 assets, and 51 sponsors run at least one.

SponsorAssets in developmentShare
Alto Neuroscience34.6%
Janssen Research & Development, LLC34.6%
Mapi Pharma Ltd.34.6%
Otsuka Pharmaceutical Development & Commercialization, Inc.34.6%
ACADIA Pharmaceuticals Inc.23.1%

Industry sponsors lead 259 of the 705 major depressive disorder trials (37%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the major depressive disorder pipeline?

Mechanism and drug-type classification for the 65 major depressive disorder candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What major depressive disorder trial readouts are coming next?

16 major depressive disorder candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

CandidateSponsorPhasePrimary completionRegistry
BPL-003Beckley Psytech LimitedPhase IINov 2026 (estimated)NCT05660642
ALTO-300Alto NeurosciencePhase IIDec 2026 (estimated)NCT05922878
SeltorexantJanssen Research & Development, LLCPhase IIIDec 2026 (estimated)NCT06559306

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many major depressive disorder readouts fall in each quarter?

26 major depressive disorder candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 6, due in Q3 2027.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026134
Q1 2027134
Q2 2027112
Q3 2027246
Q4 2027224
Q1 2028235
Q2 2028101
Q3 2028000

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most major depressive disorder trials?

United States hosts the most major depressive disorder trials, with sites in 378 of the 705 studies (54%); trials in scope run in 66 countries in all.

CountryTrials with a siteShare of trials
United States37854%
Canada8312%
Germany598.4%
China588.2%
United Kingdom578.1%
Poland547.7%
Spain436.1%
Bulgaria395.5%

A multinational major depressive disorder trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are major depressive disorder drugs being tested?

378 of the 705 major depressive disorder trials (54%) have a site in the United States, 185 (26%) in Europe and 58 (8.2%) in China; 46 of the 65 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States37854%46FDA
Europe (EU/EEA, UK, Switzerland)18526%24EMA, MHRA, Swissmedic
China588.2%14NMPA
Japan182.6%6PMDA
Rest of world19828%17national regulators

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational major depressive disorder trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the major depressive disorder pipeline since the last update?

Since 3 Oct 2026, the major depressive disorder pipeline count moved by −1 assets to 65, Phase III moved by 0 and the trial base by 0.

How does Douglas Insights count the major depressive disorder pipeline?

Douglas Insights read 705 interventional trials registered on ClinicalTrials.gov for the conditions "major depressive disorder", "treatment-resistant depression" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 65 unique candidates.

  1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
  2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
  3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
  4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

What does the Major Depressive Disorder Pipeline Review include?

The Major Depressive Disorder Pipeline Review covers all 65 candidates in an Excel tracker and profiles the leading 25 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.

11 chapters40–50 pages25 asset profilesExcel tracker of all 65 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where major depressive disorder treatment is heading.

  • Pipeline size and phase mix
  • The three calls that matter
  • What changed since the last edition
02Disease and unmet need3 pp

Who is treated today, what current therapy leaves unmet, and how regulators judge new medicines.

  • Patient population and diagnosis
  • Treatment guidelines and gaps
  • Regulatory endpoints
03Approved therapies3 pp

The marketed medicines every major depressive disorder candidate will be measured against.

  • Marketed medicines and their sponsors
  • Post-approval trials
  • The bar a new entrant must clear
04Pipeline at a glance4 pp

Every candidate counted by phase, drug type, sponsor and country.

  • Assets by phase and drug type
  • Sponsors by size of pipeline
  • Trial footprint: US, Europe, China, Japan
05Mechanism landscape and white space5 pp

Which mechanisms are crowded and which no sponsor has entered.

  • Mechanism classes and crowding
  • Classes with no candidate yet
  • Differentiation by route and dosing
06Key asset profiles12–15 pp

The leading 25 candidates, one profile each, every claim linked to a source document.

  • Design and endpoints of the pivotal trials
  • Data to date, with sources
  • Next readout and the risk to it
07Catalyst calendar3 pp

Readouts, filings and regulatory decisions 24 months ahead.

  • Readouts by quarter
  • Filings and regulatory decisions
  • Date confidence for each event
08Deals and partnering3 pp

Who is licensing, buying and partnering in major depressive disorder, and on what terms.

  • Licensing and M&A in the area
  • Deal terms where disclosed
  • Sponsors open to partnering
09Sponsor landscape3 pp

Large pharma against biotech, and how concentrated the pipeline is.

  • Pipeline share by sponsor
  • Sponsor-by-phase matrix
  • New entrants since the last edition
10Our call: winners, risks, opportunities3–4 pp

The candidates most likely to win, ranked, with the reasoning and evidence.

  • Ranked candidates
  • Risks that could change the order
  • Openings for new entrants and investors
11Methodology and source log2 pp

How the count is built and every document behind it.

  • How candidates are counted and merged
  • Every source document listed
  • The ten quality checks

Ways to buy the Major Depressive Disorder review

OptionWhat you getDeliveryPrice
Pipeline SnapshotThis therapy area as published: PDF report + Excel trackerReady nowUSD 3,000Enquire
Pipeline ReviewYour indication, geography and phase cut-off; ranked calls and an analyst call2–3 weeksFrom USD 4,000Enquire
Company AssessmentOne sponsor's full pipeline against its peers2 weeksFrom USD 5,000Enquire

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Frequently asked questions about the major depressive disorder pipeline

How many drugs are in the major depressive disorder pipeline?

65 drug candidates are in active clinical development for major depressive disorder, with 15 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most major depressive disorder drugs in development?

3 candidates make Alto Neuroscience the largest major depressive disorder pipeline sponsor, out of 51 sponsors counted by Douglas Insights.

When is the next major depressive disorder trial readout?

Nov 2026 is the registered primary completion of the Phase II trial of BPL-003 (NCT05660642), the next major depressive disorder catalyst in Douglas Insights' calendar.

How many major depressive disorder trials run in the United States and Europe?

378 major depressive disorder trials have a US site and 185 a European site, out of 705 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the major depressive disorder pipeline count updated?

90 days is the refresh cycle; this edition uses registry data as of 3 Oct 2026 and the next is due by 1 Jan 2027.

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

Cite this page Douglas Insights (2026). Major Depressive Disorder Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/major-depressive-disorder/