Acute Myeloid Leukemia has 204 drug candidates in active clinical development, of which 18 are in Phase III, 41 in Phase II and 145 in Phase I, according to Douglas Insights' count of 1,695 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).
The acute myeloid 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 myeloid leukemia drugs are in each phase of development?
Douglas Insights counts 18 acute myeloid leukemia candidates in Phase III, 8.8% of the 204 assets in development; Phase II holds 41 and Phase I holds 145.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 18 | 8.8% |
| Phase II | 41 | 20% |
| Phase I | 145 | 71% |
| Total | 204 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each acute myeloid leukemia asset appears in exactly one row. The 774 trials still recruiting or running carry 46% of the 1,695 registered trials in scope.
Which approved acute myeloid leukemia medicines are still in trials?
1 medicines already on the market are still being tested in acute myeloid leukemia Phase IV trials; Olutasidenib has the most, with 9 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Olutasidenib | Several sponsors | 9 |
Post-approval acute myeloid leukemia 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 acute myeloid leukemia trials are recruiting patients now?
456 acute myeloid leukemia trials are recruiting patients and 122 more have not started recruiting yet, out of 1,695 interventional trials in scope; together they make up 34% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 471 | 28% |
| Recruiting | 456 | 27% |
| Terminated | 259 | 15% |
| Active, not recruiting | 183 | 11% |
| Not yet recruiting | 122 | 7.2% |
| Status not verified | 119 | 7.0% |
| Withdrawn | 54 | 3.2% |
| Suspended | 18 | 1.1% |
| Enrolling by invitation | 13 | 0.8% |
Terminated, suspended and withdrawn acute myeloid leukemia trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as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 myeloid leukemia pipeline?
Beijing Biotech leads the acute myeloid leukemia pipeline with 8 candidates; the top 5 sponsors hold 14% of the 204 assets, and 142 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| Beijing Biotech | 8 | 3.9% |
| CellCentric Ltd. | 8 | 3.9% |
| Hoffmann-La Roche | 5 | 2.5% |
| Ascentage Pharma Group Inc. | 4 | 2.0% |
| Lomond Therapeutics Holdings, Inc. | 4 | 2.0% |
Industry sponsors lead 521 of the 1,695 acute myeloid leukemia trials (31%); 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 myeloid leukemia pipeline?
Mechanism and drug-type classification for the 204 acute myeloid 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 myeloid leukemia trial readouts are coming next?
18 acute myeloid 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.
| Candidate | Sponsor | Phase | Primary completion | Registry |
|---|---|---|---|---|
| Gilteritinib | Astellas Pharma Global Development, Inc. | Phase II | Oct 2026 (estimated) | NCT06022003 |
| FCN-338 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Phase II | Dec 2026 (estimated) | NCT06858618 |
| Clofarabine | Genzyme, a Sanofi Company | Phase II | Dec 2026 (estimated) | NCT04644016 |
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 myeloid leukemia readouts fall in each quarter?
27 acute myeloid leukemia candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 7, due in Q2 2027.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 0 | 4 | 4 |
| Q1 2027 | 0 | 4 | 4 |
| Q2 2027 | 1 | 6 | 7 |
| Q3 2027 | 1 | 2 | 3 |
| Q4 2027 | 1 | 6 | 7 |
| Q1 2028 | 0 | 1 | 1 |
| Q2 2028 | 0 | 0 | 0 |
| Q3 2028 | 0 | 1 | 1 |
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 myeloid leukemia trials?
United States hosts the most acute myeloid leukemia trials, with sites in 990 of the 1,695 studies (58%); trials in scope run in 73 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| United States | 990 | 58% |
| China | 359 | 21% |
| France | 185 | 11% |
| Germany | 150 | 8.8% |
| Spain | 150 | 8.8% |
| Italy | 130 | 7.7% |
| Canada | 118 | 7.0% |
| Australia | 109 | 6.4% |
A multinational acute myeloid 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 myeloid leukemia drugs being tested?
990 of the 1,695 acute myeloid leukemia trials (58%) have a site in the United States, 361 (21%) in Europe and 359 (21%) in China; 142 of the 204 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 990 | 58% | 142 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 361 | 21% | 93 | EMA, MHRA, Swissmedic |
| China | 359 | 21% | 62 | NMPA |
| Japan | 55 | 3.2% | 18 | PMDA |
| Rest of world | 264 | 16% | 80 | national 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 myeloid 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 myeloid leukemia pipeline since the last update?
This is the first edition of the acute myeloid 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 myeloid leukemia pipeline?
Douglas Insights read 1,695 interventional trials registered on ClinicalTrials.gov for the conditions "acute myeloid leukemia" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 204 unique candidates.
- 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.
- 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.
- Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
- 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 Myeloid Leukemia Pipeline Review include?
The Acute Myeloid Leukemia Pipeline Review covers all 204 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.
01Executive summary and our call2–3 pp
The pipeline on one page and the desk's verdict on where acute myeloid 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 myeloid 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 myeloid 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
Ways to buy the Acute Myeloid Leukemia review
| Option | What you get | Delivery | Price | |
|---|---|---|---|---|
| Pipeline Snapshot | This therapy area as published: PDF report + Excel tracker | Ready now | USD 3,000 | Enquire |
| Pipeline Review | Your indication, geography and phase cut-off; ranked calls and an analyst call | 2–3 weeks | From USD 4,000 | Enquire |
| Company Assessment | One sponsor's full pipeline against its peers | 2 weeks | From USD 5,000 | Enquire |
Frequently asked questions about the acute myeloid leukemia pipeline
How many drugs are in the acute myeloid leukemia pipeline?
204 drug candidates are in active clinical development for acute myeloid leukemia, with 18 in Phase III, per Douglas Insights (data as of 3 Oct 2026).
Which company has the most acute myeloid leukemia drugs in development?
8 candidates make Beijing Biotech the largest acute myeloid leukemia pipeline sponsor, out of 142 sponsors counted by Douglas Insights.
When is the next acute myeloid leukemia trial readout?
Oct 2026 is the registered primary completion of the Phase II trial of Gilteritinib (NCT06022003), the next acute myeloid leukemia catalyst in Douglas Insights' calendar.
How many acute myeloid leukemia trials run in the United States and Europe?
990 acute myeloid leukemia trials have a US site and 361 a European site, out of 1,695 registered trials counted by Douglas Insights (data as of 3 Oct 2026).
How often is the acute myeloid 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.
Douglas Insights (2026). Acute Myeloid Leukemia Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/acute-myeloid-leukemia/