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Drug Pipeline Review Therapy area: Malaria40–50 pages · PDF + Excel tracker

Malaria Drug Pipeline: 24 Assets by Phase

Malaria pipeline: 24 drug candidates in clinical development, 1 in Phase III, from 10 sponsors. Data as of 4 Oct 2026.

Pipeline Terminal Malaria Data as of 4 Oct 2026
Candidates in development 24assets 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 14.2% 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 1250% of pipeline Registry
Phase I 1146% of pipeline Registry
Sponsors 10top 5 hold 71% 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 32879 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 4 Oct 2021.
Readouts in 12 months 6Phase 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 216.4% · Europe 11% 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 I11
Phase II12
Phase III1

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
R21Phase IIDec 2026 (est.)
CipargaminPhase IIFeb 2027 (est.)
KLU156Phase IIFeb 2027 (est.)

Candidates in development by lead sponsor

GlaxoSmithKline4
Novartis Pharmaceuticals4
Sanaria Inc.3
Guangzhou Patronus Biotech Co., Ltd.3
Serum Institute of India Pvt. Ltd.3

Phase II and III primary completions per quarter

Q4 20261
Q1 20273
Q2 20271
Q3 20271
Q4 20271
Q1 20280
Q2 20280
Q3 20281

Answers at a glance

  • 1 of 24 malaria candidates (4.2%) are in Phase III.
  • GlaxoSmithKline runs the largest malaria pipeline, with 4 candidates.
  • 6 readouts are due in 12 months; the next is R21 in Dec 2026.
  • 29 trials are recruiting patients now; 6.4% of all trials have a US site and 11% a European one.
24 candidates328 trials54 countriesData as of 4 Oct 2026Next refresh by 2 Jan 2027
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Edition: data as of 4 Oct 2026 Next refresh: by 2 Jan 2027 Change: First edition

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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 I11Phase II12Phase III1
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 4 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III14.2%
Phase II1250%
Phase I1146%
Total24100%

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.

MedicineLead sponsorRegistered trials
Artemether-lumefantrineNovartis Pharmaceuticals55
PrimaquineGlaxoSmithKline28
ChloroquineGlaxoSmithKline19
TafenoquineGlaxoSmithKline18
ArtesunateNovartis Pharmaceuticals7

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 statusTrialsShare
Completed19459%
Status not verified319.5%
Recruiting298.8%
Not yet recruiting288.5%
Active, not recruiting226.7%
Terminated134.0%
Withdrawn72.1%
Suspended41.2%

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.

SponsorAssets in developmentShare
GlaxoSmithKline417%
Novartis Pharmaceuticals417%
Sanaria Inc.313%
Guangzhou Patronus Biotech Co., Ltd.313%
Serum Institute of India Pvt. Ltd.313%

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.

CandidateSponsorPhasePrimary completionRegistry
R21Serum Institute of India Pvt. Ltd.Phase IIDec 2026 (estimated)NCT07183371
CipargaminNovartis PharmaceuticalsPhase IIFeb 2027 (estimated)NCT07811908
KLU156Novartis PharmaceuticalsPhase IIFeb 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.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026011
Q1 2027033
Q2 2027011
Q3 2027011
Q4 2027011
Q1 2028000
Q2 2028000
Q3 2028011

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.

CountryTrials with a siteShare of trials
Burkina Faso4213%
Mali3711%
Uganda3310%
Kenya319.5%
United Kingdom226.7%
Thailand216.4%
United States216.4%
Gabon206.1%

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.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States216.4%5FDA
Europe (EU/EEA, UK, Switzerland)3611%5EMA, MHRA, Swissmedic
China41.2%0NMPA
Japan00.0%0PMDA
Rest of world25076%18national 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.

  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 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.

11 chapters40–50 pages25 asset profilesExcel tracker of all 24 candidates
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

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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 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.

Cite this page Douglas Insights (2026). Malaria Drug Pipeline, data as of 4 Oct 2026. https://www.douglasinsights.com/pipeline/malaria/