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Drug Pipeline Review Therapy area: Acute Lymphoblastic Leukemia40–50 pages · PDF + Excel tracker

Acute Lymphoblastic Leukemia Drug Pipeline: 111 Assets by Phase

Acute Lymphoblastic Leukemia pipeline: 111 drug candidates in clinical development, 6 in Phase III, from 73 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Acute Lymphoblastic Leukemia Data as of 3 Oct 2026
Candidates in development 111assets 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 65.4% 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 2119% of pipeline Registry
Phase I 8476% of pipeline Registry
Sponsors 73top 5 hold 23% 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 1,106567 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 12Phase 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 56251% · Europe 18% 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 I84
Phase II21
Phase III6

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
NelarabinePhase IIOct 2026 (est.)
Inotuzumab OzogamicinPhase IINov 2026 (est.)
MogamulizumabPhase IINov 2026 (est.)

Candidates in development by lead sponsor

Beijing Biotech8
Novartis Pharmaceuticals6
Chongqing Precision Biotech Co., Ltd4
AstraZeneca4
Sumitomo Pharma America, Inc.4

Phase II and III primary completions per quarter

Q4 20267
Q1 20273
Q2 20271
Q3 20271
Q4 20271
Q1 20280
Q2 20282
Q3 20280

Answers at a glance

  • 6 of 111 acute lymphoblastic leukemia candidates (5.4%) are in Phase III.
  • Beijing Biotech runs the largest acute lymphoblastic leukemia pipeline, with 8 candidates.
  • 12 readouts are due in 12 months; the next is Nelarabine in Oct 2026.
  • 334 trials are recruiting patients now; 51% of all trials have a US site and 18% a European one.
111 candidates1,106 trials63 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Acute Lymphoblastic Leukemia has 111 drug candidates in active clinical development, of which 6 are in Phase III, 21 in Phase II and 84 in Phase I, according to Douglas Insights' count of 1,106 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The acute lymphoblastic leukemia 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 acute lymphoblastic leukemia drugs are in each phase of development?

Douglas Insights counts 6 acute lymphoblastic leukemia candidates in Phase III, 5.4% of the 111 assets in development; Phase II holds 21 and Phase I holds 84.

Phase I84Phase II21Phase III6
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III65.4%
Phase II2119%
Phase I8476%
Total111100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each acute lymphoblastic leukemia asset appears in exactly one row. The 567 trials still recruiting or running carry 51% of the 1,106 registered trials in scope.

How many acute lymphoblastic leukemia trials are recruiting patients now?

334 acute lymphoblastic leukemia trials are recruiting patients and 75 more have not started recruiting yet, out of 1,106 interventional trials in scope; together they make up 37% of the trial base.

Registry statusTrialsShare
Recruiting33430%
Completed28726%
Active, not recruiting15414%
Terminated1069.6%
Status not verified918.2%
Not yet recruiting756.8%
Withdrawn423.8%
Suspended131.2%
Enrolling by invitation40.4%

Terminated, suspended and withdrawn acute lymphoblastic leukemia 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 acute lymphoblastic leukemia pipeline?

Beijing Biotech leads the acute lymphoblastic leukemia pipeline with 8 candidates; the top 5 sponsors hold 23% of the 111 assets, and 73 sponsors run at least one.

SponsorAssets in developmentShare
Beijing Biotech87.2%
Novartis Pharmaceuticals65.4%
Chongqing Precision Biotech Co., Ltd43.6%
AstraZeneca43.6%
Sumitomo Pharma America, Inc.43.6%

Industry sponsors lead 217 of the 1,106 acute lymphoblastic leukemia trials (20%); 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 acute lymphoblastic leukemia pipeline?

Mechanism and drug-type classification for the 111 acute lymphoblastic leukemia 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 acute lymphoblastic leukemia trial readouts are coming next?

12 acute lymphoblastic leukemia 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
NelarabineChia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase IIOct 2026 (estimated)NCT00501826
Inotuzumab OzogamicinPfizerPhase IINov 2026 (estimated)NCT02877303
MogamulizumabKyowa Kirin, Inc.Phase IINov 2026 (estimated)NCT05996185

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 acute lymphoblastic leukemia readouts fall in each quarter?

15 acute lymphoblastic leukemia candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 7, due in Q4 2026.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026167
Q1 2027123
Q2 2027011
Q3 2027011
Q4 2027011
Q1 2028000
Q2 2028022
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 acute lymphoblastic leukemia trials?

United States hosts the most acute lymphoblastic leukemia trials, with sites in 562 of the 1,106 studies (51%); trials in scope run in 63 countries in all.

CountryTrials with a siteShare of trials
United States56251%
China26824%
Italy777.0%
France756.8%
Canada746.7%
Germany726.5%
Spain676.1%
Australia635.7%

A multinational acute lymphoblastic leukemia 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 acute lymphoblastic leukemia drugs being tested?

562 of the 1,106 acute lymphoblastic leukemia trials (51%) have a site in the United States, 194 (18%) in Europe and 268 (24%) in China; 64 of the 111 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States56251%64FDA
Europe (EU/EEA, UK, Switzerland)19418%48EMA, MHRA, Swissmedic
China26824%44NMPA
Japan292.6%21PMDA
Rest of world20819%47national 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 acute lymphoblastic leukemia 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 acute lymphoblastic leukemia pipeline since the last update?

This is the first edition of the acute lymphoblastic leukemia 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 acute lymphoblastic leukemia pipeline?

Douglas Insights read 1,106 interventional trials registered on ClinicalTrials.gov for the conditions "precursor cell lymphoblastic leukemia-lymphoma", "acute lymphoblastic leukemia" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 111 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 Acute Lymphoblastic Leukemia Pipeline Review include?

The Acute Lymphoblastic Leukemia Pipeline Review covers all 111 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 111 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where acute lymphoblastic leukemia 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 acute lymphoblastic leukemia 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 acute lymphoblastic leukemia, 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

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Frequently asked questions about the acute lymphoblastic leukemia pipeline

How many drugs are in the acute lymphoblastic leukemia pipeline?

111 drug candidates are in active clinical development for acute lymphoblastic leukemia, with 6 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most acute lymphoblastic leukemia drugs in development?

8 candidates make Beijing Biotech the largest acute lymphoblastic leukemia pipeline sponsor, out of 73 sponsors counted by Douglas Insights.

When is the next acute lymphoblastic leukemia trial readout?

Oct 2026 is the registered primary completion of the Phase II trial of Nelarabine (NCT00501826), the next acute lymphoblastic leukemia catalyst in Douglas Insights' calendar.

How many acute lymphoblastic leukemia trials run in the United States and Europe?

562 acute lymphoblastic leukemia trials have a US site and 194 a European site, out of 1,106 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the acute lymphoblastic leukemia 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). Acute Lymphoblastic Leukemia Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/acute-lymphoblastic-leukemia/