Malaria has 24 drug candidates in active clinical development, of which 1 are in Phase III, 12 in Phase II and 11 in Phase I, according to Douglas Insights' count of 328 interventional trials registered on ClinicalTrials.gov (data as of 4 Oct 2026).
The malaria 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 malaria drugs are in each phase of development?
Douglas Insights counts 1 malaria candidates in Phase III, 4.2% of the 24 assets in development; Phase II holds 12 and Phase I holds 11.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 1 | 4.2% |
| Phase II | 12 | 50% |
| Phase I | 11 | 46% |
| Total | 24 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each malaria asset appears in exactly one row. The 79 trials still recruiting or running carry 24% of the 328 registered trials in scope.
Which approved malaria medicines are still in trials?
5 medicines already on the market are still being tested in malaria Phase IV trials; Artemether-lumefantrine has the most, with 55 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Artemether-lumefantrine | Novartis Pharmaceuticals | 55 |
| Primaquine | GlaxoSmithKline | 28 |
| Chloroquine | GlaxoSmithKline | 19 |
| Tafenoquine | GlaxoSmithKline | 18 |
| Artesunate | Novartis Pharmaceuticals | 7 |
Post-approval malaria 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 malaria trials are recruiting patients now?
29 malaria trials are recruiting patients and 28 more have not started recruiting yet, out of 328 interventional trials in scope; together they make up 17% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 194 | 59% |
| Status not verified | 31 | 9.5% |
| Recruiting | 29 | 8.8% |
| Not yet recruiting | 28 | 8.5% |
| Active, not recruiting | 22 | 6.7% |
| Terminated | 13 | 4.0% |
| Withdrawn | 7 | 2.1% |
| Suspended | 4 | 1.2% |
Terminated, suspended and withdrawn malaria trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.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 malaria pipeline?
GlaxoSmithKline leads the malaria pipeline with 4 candidates; the top 5 sponsors hold 71% of the 24 assets, and 10 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| GlaxoSmithKline | 4 | 17% |
| Novartis Pharmaceuticals | 4 | 17% |
| Sanaria Inc. | 3 | 13% |
| Guangzhou Patronus Biotech Co., Ltd. | 3 | 13% |
| Serum Institute of India Pvt. Ltd. | 3 | 13% |
Industry sponsors lead 55 of the 328 malaria trials (17%); 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 malaria pipeline?
Mechanism and drug-type classification for the 24 malaria 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 malaria trial readouts are coming next?
6 malaria 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 |
|---|---|---|---|---|
| R21 | Serum Institute of India Pvt. Ltd. | Phase II | Dec 2026 (estimated) | NCT07183371 |
| Cipargamin | Novartis Pharmaceuticals | Phase II | Feb 2027 (estimated) | NCT07811908 |
| KLU156 | Novartis Pharmaceuticals | Phase II | Feb 2027 (estimated) | NCT07811908 |
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 malaria readouts fall in each quarter?
8 malaria candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 3, due in Q1 2027.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 0 | 1 | 1 |
| Q1 2027 | 0 | 3 | 3 |
| Q2 2027 | 0 | 1 | 1 |
| Q3 2027 | 0 | 1 | 1 |
| Q4 2027 | 0 | 1 | 1 |
| Q1 2028 | 0 | 0 | 0 |
| 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 malaria trials?
Burkina Faso hosts the most malaria trials, with sites in 42 of the 328 studies (13%); trials in scope run in 54 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| Burkina Faso | 42 | 13% |
| Mali | 37 | 11% |
| Uganda | 33 | 10% |
| Kenya | 31 | 9.5% |
| United Kingdom | 22 | 6.7% |
| Thailand | 21 | 6.4% |
| United States | 21 | 6.4% |
| Gabon | 20 | 6.1% |
A multinational malaria 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 malaria drugs being tested?
21 of the 328 malaria trials (6.4%) have a site in the United States, 36 (11%) in Europe and 4 (1.2%) in China; 5 of the 24 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 21 | 6.4% | 5 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 36 | 11% | 5 | EMA, MHRA, Swissmedic |
| China | 4 | 1.2% | 0 | NMPA |
| Japan | 0 | 0.0% | 0 | PMDA |
| Rest of world | 250 | 76% | 18 | 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 malaria 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 malaria pipeline since the last update?
This is the first edition of the malaria pipeline count, dated 4 Oct 2026. The next refresh is due by 2 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.
How does Douglas Insights count the malaria pipeline?
Douglas Insights read 328 interventional trials registered on ClinicalTrials.gov for the conditions "Malaria", "Malaria, Falciparum" and updated since 4 Oct 2021, then grouped every drug or biologic named in them into 24 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 Malaria Pipeline Review include?
The Malaria Pipeline Review covers all 24 candidates in an Excel tracker and profiles the leading 24 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 malaria 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 malaria 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 malaria, 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 Malaria 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 malaria pipeline
How many drugs are in the malaria pipeline?
24 drug candidates are in active clinical development for malaria, with 1 in Phase III, per Douglas Insights (data as of 4 Oct 2026).
Which company has the most malaria drugs in development?
4 candidates make GlaxoSmithKline the largest malaria pipeline sponsor, out of 10 sponsors counted by Douglas Insights.
When is the next malaria trial readout?
Dec 2026 is the registered primary completion of the Phase II trial of R21 (NCT07183371), the next malaria catalyst in Douglas Insights' calendar.
How many malaria trials run in the United States and Europe?
21 malaria trials have a US site and 36 a European site, out of 328 registered trials counted by Douglas Insights (data as of 4 Oct 2026).
How often is the malaria pipeline count updated?
90 days is the refresh cycle; this edition uses registry data as of 4 Oct 2026 and the next is due by 2 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). Malaria Drug Pipeline, data as of 4 Oct 2026. https://www.douglasinsights.com/pipeline/malaria/