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Drug Pipeline Review Therapy area: Schizophrenia40–50 pages · PDF + Excel tracker

Schizophrenia Drug Pipeline: 65 Assets by Phase

Schizophrenia pipeline: 65 drug candidates in clinical development, 15 in Phase III, from 44 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Schizophrenia 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 2132% of pipeline Registry
Phase I 2945% of pipeline Registry
Sponsors 44top 5 hold 29% 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 611174 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 32253% · Europe 23% 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 I29
Phase II21
Phase III15

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
SEP363856Phase IIIOct 2026 (est.)
KYN-5356Phase IIOct 2026 (est.)
NS-136Phase IINov 2026 (est.)

Candidates in development by lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.5
Boryung Pharmaceutical Co., Ltd4
Rovi Pharmaceuticals Laboratories4
Mapi Pharma Ltd.3
Humanis Saglık Anonim Sirketi3

Phase II and III primary completions per quarter

Q4 20265
Q1 20271
Q2 20275
Q3 20275
Q4 20276
Q1 20282
Q2 20280
Q3 20282

Answers at a glance

  • 15 of 65 schizophrenia candidates (23%) are in Phase III.
  • Otsuka Pharmaceutical Development & Commercialization, Inc. runs the largest schizophrenia pipeline, with 5 candidates.
  • 16 readouts are due in 12 months; the next is SEP363856 in Oct 2026.
  • 109 trials are recruiting patients now; 53% of all trials have a US site and 23% a European one.
65 candidates611 trials62 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: First edition

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Schizophrenia has 65 drug candidates in active clinical development, of which 15 are in Phase III, 21 in Phase II and 29 in Phase I, according to Douglas Insights' count of 611 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The schizophrenia 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 schizophrenia drugs are in each phase of development?

Douglas Insights counts 15 schizophrenia candidates in Phase III, 23% of the 65 assets in development; Phase II holds 21 and Phase I holds 29.

Phase I29Phase II21Phase 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 II2132%
Phase I2945%
Total65100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each schizophrenia asset appears in exactly one row. The 174 trials still recruiting or running carry 28% of the 611 registered trials in scope.

Which approved schizophrenia medicines are still in trials?

10 medicines already on the market are still being tested in schizophrenia Phase IV trials; Risperidone has the most, with 45 registered trials.

MedicineLead sponsorRegistered trials
RisperidoneSeveral sponsors45
AripiprazoleSeveral sponsors34
OlanzapineSeveral sponsors34
ClozapineWhanin Pharmaceutical Company15
KarXTKaruna Therapeutics, Inc., a Bristol Myers Squibb company13
Paliperidone palmitateSeveral sponsors10
QuetiapineSeveral sponsors9
PaliperidoneSeveral sponsors8

Post-approval schizophrenia 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 schizophrenia trials are recruiting patients now?

109 schizophrenia trials are recruiting patients and 39 more have not started recruiting yet, out of 611 interventional trials in scope; together they make up 24% of the trial base.

Registry statusTrialsShare
Completed33855%
Recruiting10918%
Terminated487.9%
Not yet recruiting396.4%
Status not verified355.7%
Active, not recruiting203.3%
Withdrawn142.3%
Enrolling by invitation61.0%
Suspended20.3%

Terminated, suspended and withdrawn schizophrenia 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 schizophrenia pipeline?

Otsuka Pharmaceutical Development & Commercialization, Inc. leads the schizophrenia pipeline with 5 candidates; the top 5 sponsors hold 29% of the 65 assets, and 44 sponsors run at least one.

SponsorAssets in developmentShare
Otsuka Pharmaceutical Development & Commercialization, Inc.57.7%
Boryung Pharmaceutical Co., Ltd46.2%
Rovi Pharmaceuticals Laboratories46.2%
Mapi Pharma Ltd.34.6%
Humanis Saglık Anonim Sirketi34.6%

Industry sponsors lead 302 of the 611 schizophrenia trials (49%); 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 schizophrenia pipeline?

Mechanism and drug-type classification for the 65 schizophrenia 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 schizophrenia trial readouts are coming next?

16 schizophrenia 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
SEP363856Otsuka Pharmaceutical Development & Commercialization, Inc.Phase IIIOct 2026 (estimated)NCT06894212
KYN-5356Kynexis B.V.Phase IIOct 2026 (estimated)NCT07191483
NS-136NeuShen TherapeuticsPhase IINov 2026 (estimated)NCT07521683

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 schizophrenia readouts fall in each quarter?

26 schizophrenia candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 6, due in Q4 2027.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026325
Q1 2027101
Q2 2027145
Q3 2027145
Q4 2027246
Q1 2028112
Q2 2028000
Q3 2028112

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 schizophrenia trials?

United States hosts the most schizophrenia trials, with sites in 322 of the 611 studies (53%); trials in scope run in 62 countries in all.

CountryTrials with a siteShare of trials
United States32253%
China6310%
Bulgaria406.5%
Japan396.4%
Spain376.1%
Ukraine335.4%
Taiwan325.2%
United Kingdom325.2%

A multinational schizophrenia 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 schizophrenia drugs being tested?

322 of the 611 schizophrenia trials (53%) have a site in the United States, 138 (23%) in Europe and 63 (10%) in China; 35 of the 65 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States32253%35FDA
Europe (EU/EEA, UK, Switzerland)13823%16EMA, MHRA, Swissmedic
China6310%13NMPA
Japan396.4%6PMDA
Rest of world17028%34national 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 schizophrenia 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 schizophrenia pipeline since the last update?

This is the first edition of the schizophrenia pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the schizophrenia pipeline?

Douglas Insights read 611 interventional trials registered on ClinicalTrials.gov for the conditions "schizophrenia" 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 Schizophrenia Pipeline Review include?

The Schizophrenia 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 schizophrenia 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 schizophrenia 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 schizophrenia, 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 Schizophrenia review

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Pipeline ReviewYour indication, geography and phase cut-off; ranked calls and an analyst call2–3 weeksFrom USD 4,000Enquire
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Frequently asked questions about the schizophrenia pipeline

How many drugs are in the schizophrenia pipeline?

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

Which company has the most schizophrenia drugs in development?

5 candidates make Otsuka Pharmaceutical Development & Commercialization, Inc. the largest schizophrenia pipeline sponsor, out of 44 sponsors counted by Douglas Insights.

When is the next schizophrenia trial readout?

Oct 2026 is the registered primary completion of the Phase III trial of SEP363856 (NCT06894212), the next schizophrenia catalyst in Douglas Insights' calendar.

How many schizophrenia trials run in the United States and Europe?

322 schizophrenia trials have a US site and 138 a European site, out of 611 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the schizophrenia 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). Schizophrenia Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/schizophrenia/